Food & Beverage

CDMO / CRO

Pharmaceutical

Cellular Agriculture

Comprehensive Checklist for Bioprocessing Data Ontology

Your checklist for implementing Electronic Batch Records (EBR) at your organisation.   .

Your checklist for implementing Electronic Batch Records (EBR) at your organisation.

Chemicals

Medical Device

EBR Implementation Checklist

T﻿he ultimate guide to batch records.   .

Electronic Batch Records: The Ultimate Guide 

T﻿he Ultimate Guide to Electronic Lab Notebooks (ELN).   .

T﻿he Ultimate Guide to Electronic Lab Notebooks (ELN).

Electronic Lab Notebooks: The Ultimate Guide

Y﻿our checklist for implementing an Electronic Lab Notebook.   .

Y﻿our checklist for implementing an Electronic Lab Notebook.

ELN Implementation Checklist

Download Opvia's template for selecting the best Electronic Lab Notebook (ELN) software for your organisation's needs. Compare features from various vendors and make an informed choice to improve your research and data management processes.

ELN Vendor Evaluation Template

Good Laboratory Practices (GLP): The Ultimate Guide

Good Manufacturing Practices (GMP): The Ultimate Guide

Y﻿our checklist for implementing a LIMS.   .

Y﻿our checklist for implementing a LIMS.

LIMS Implementation Checklist

Y﻿our checklist for evaluating LIMS providers.   .

Y﻿our checklist for evaluating LIMS providers.

LIMS Vendor Evaluation Checklist

This Manufacturing Quality Control Template template is a tool for overseeing and analysing product quality within the manufacturing industry. Useful for production managers, quality assurance teams, and factory supervisors, it simplifies the tracking of manufacturing metrics.  Features of this spreadsheet template include: * **Production data tracking**: capture specifics such as plant location, machine IDs, production dates, and operator details.

This Manufacturing Quality Control Template template is a tool for overseeing and analysing product quality within the manufacturing industry. Useful for production managers, quality assurance teams, and factory supervisors, it simplifies the tracking of manufacturing metrics. 

Features of this spreadsheet template include:

* **Production data tracking**: capture specifics such as plant location, machine IDs, production dates, and operator details.
* **Quality assessment**: rate batch quality (0-100%), with sections for comprehensive feedback on manufacturing imperfections.
* **Manufacturing statistics**: columns for recording batch dates, sample sizes, average quality scores, variance, standard deviations, and control limits.
* **Visual quality trends**: incorporates a graph to visually depict quality progression over time, assisting in identifying patterns or declines in product quality.

!["Manufacturing quality control spreadsheet template showcasing plant details, machine IDs, production timelines, and operator information. Includes quality ratings (0-100%), feedback areas, statistical data columns (dates, sample sizes, scores, variance, standard deviations, control limits), and a graph for visual trend analysis. Designed for easy tracking and analysis by production managers and quality teams.](media/screenshot-2024-04-11-at-12.39.32.png "Manufacturing Quality Control Template")

### How to use this template:

1. **Initial setup**: enter basic manufacturing details like machinery and production timelines.
2. **Quality benchmarks**: establish standard quality levels and control limits for production batches.
3. **Data input**: log production data regularly, including quality scores and any manufacturing anomalies.
4. **Analysis**: use the graph to visually track quality trends, facilitating early detection of potential issues.

Manufacturing Quality Control [Free Template]

Y﻿our complete guide for migrating from paper to digital.   .

Y﻿our complete guide for migrating from paper to digital.

Migrating from Paper to Digital: The Complete Guide

This Product Quality Control Chart Sample Template is a practical tool designed to simplify the monitoring and analysis of product quality across various industries.

This Product Quality Control Chart Sample Template is a practical tool designed to simplify the monitoring and analysis of product quality across various industries. Whether a small business owner, a quality control technician, or someone involved in the production process, this template provides a simple way to track and visualise quality data.\
\
This spreadsheet template features include:

* **Comprehensive Data Tracking**: Easily record and access data with fields for location name, location ID, start and end dates, report date, department, quality control technician, equipment name, and equipment ID.
* **Quality analysis**: Evaluate product quality levels (0-100%), including detailed comments for in-depth analysis.
* **Statistical table**: Includes columns for date, multiple samples, mean, sample Mean, standard Deviation, sample standard deviation, lower control limit, and upper control limit.
* **Visual output**: A line graph that dynamically illustrates your data, offering a clear visual representation of your product's quality over time.

![An image of the spreadsheet template, showing a top section basic information to fill in such as location, department, equipment name and ID. Followed by a table for data entry with upper and lower control limits. Lastly, a line graph showing the output of the quality control sample data. ](media/screenshot-2024-04-11-at-12.14.19.png "Product Quality Control Chart [Template] ")

H﻿ow to use the template

1. **Setup** —fill in basic information e.g. location details, report dates, & equipment used.
2. **Set quality levels** — specify your target quality levels for analysis and add any relevant notes.
3. **Input data** —enter your data for each period, including values for each sample & statistical measures.
4. **Control limits** —determine and record the lower and upper control limits to spot potential quality issues.
5. **Graphical analysis** —use the provided line graph to visualise your quality control data, making it easier to spot trends.

Product Quality Control Chart [Template] 

Y﻿our checklist for implementing a QMS at your organisation.   .

Y﻿our checklist for implementing a QMS at your organisation.

QMS Implementation Checklist

Download Opvia's template for selecting the best Quality Management System (QMS) software for your organisation's needs. Compare features from various vendors and make an informed decision to enhance your quality control processes.

QMS Vendor Evaluation Template

T﻿he Ultimate Guide to Quality Management Systems (QMS).   .

T﻿he Ultimate Guide to Quality Management Systems (QMS).

Quality Management Systems: The Ultimate Guide

Get the source-code for the visualisations described in our article - Source Code for 10 Spectacular Biotech Visualisations You Can Build With Opvia.   .

Get the source-code for the visualisations described in our article - Source Code for 10 Spectacular Biotech Visualisations You Can Build With Opvia.

Source Code for "10 Spectacular Biotech Visualisations You Can Build With Opvia"

Unlock the Potential of Quality Management Systems

Explore how Opvia's Platform is used – from startups and FTSE 500s – in the CDMO / CRO industry

Develop flexible templates to execute unit operations for new recipes or formulations

Collect data from lab tests, keep track of inventory with connected databases

Automate data upload, embed visualisations or execute ML models to move faster

Iteratively bring structure to development with version control, comments and sign-off

Define processes, connect data and have complete control over your procedures

Discover your lead candidate sooner and bring your products to market faster. 

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Learning Center

Manufacturers looking to adopt electronic batch records (EBR systems) often find decision-making difficult. Pinpointing exactly what features will best serve their organisation isn't always easy.  Choosing the system that will drive your entire manufacturing process is not a light decision.

Manufacturers looking to adopt electronic batch records (EBR systems) often find decision-making difficult. Pinpointing exactly what features will best serve their organisation isn't always easy. 

Choosing the system that will drive your entire manufacturing process is not a light decision. These systems can come with high upfront costs, and investing months on implementing a system and training up teams—only to discover it falls short—can be a massive waste of time and money. On top of this, a bad system can grind operations to a halt, lead to non-compliance, or even invoke lawsuits.

There are some horror stories about companies that have made the leap to a new enterprise software solution. Invacare, a medical device manufacturer, had [major setbacks during a product update in 2021](https://www.techtarget.com/searcherp/feature/7-reasons-for-ERP-implementation-failure) when they moved over to a new SAP ERP system. Likewise, MillerCoors aimed to consolidate its finances onto a single ERP system (2014) but [faced a long lawsuit](https://www.techtarget.com/searcherp/news/252454237/MillerCoors-ERP-lawsuit-begins-harshly-ends-softly) as a result of critical defects and poor planning in the project managed by HCL Technologies.

This article is intended to be a handy EBR system comparison guide to help you decide on your EBR. We've carefully evaluated the top 5 EBR systems, ranking them based on crucial criteria like compliance, scalability, and integration capabilities.

# What is an EBR?

An Electronic Batch Record (EBR) workflow is a digital process which involves  capturing and managing data and documentation during the manufacturing of goods. This kind of advanced workflow is essential in regulated industries with high levels of quality control and compliance, like pharmaceuticals, biotech and the food & beverages. 

If you’re confused by any of this, we’ve written other articles about EBRs that you might be interested in:

* [What is a batch manufacturing record? A brief overview](https://www.opvia.io/learning-center/what-is-a-batch-manufacturing-record-a-brief-overview)
* [How to improve your EBR workflow - step by step](https://www.opvia.io/learning-center/how-to-improve-your-ebr-workflow-step-by-step)

# What makes a great EBR system? 

Choosing the right Electronic Batch Record (EBR) system is essential for manufacturers that want to ensure compliance and be as efficient as possible. The best EBR systems stand out by not just meeting this basic criteria but also by being incredibly intuitive to use, customisable and enabling you to have visibility over all your processes.  

### Here is the key criteria when comparing EBR systems:

#### **Compliance** 

Clearly, an EBR system needs to be compliant with relevant standards. Otherwise what’s the point? Standards like FDA 21 CFR Part 11 are non-negotiable. The chosen system should include features such as audit trails and electronic signatures.

#### **Integration**

EBR systems need to be able to integrate seamlessly with other systems like enterprise resource planning (ERP), quality management systems (QMS), and manufacturing execution systems (MES). Systems that offer API access and support standard data exchange formats will make your life a lot easier by accommodating your existing software solutions. 

#### **Scalability**

The ability for an EBR system to scale is pretty crucial. As a business grows, the system should be able to handle increased production without affecting performance. Equally, the provider should be able to accommodate other tools and features in the product life cycle like quality management, R&D, or other manufacturing solutions. Try to look for systems that offer modular upgrades, or that can easily expand in both capacity and in functionality offered. 

#### **User experience (UX)**

A user-friendly interface is important, especially if dealing with complex systems processes. Intuitive navigation, clear display, and easy access to different features go along way in terms of reducing training time and errors. You should also look for mobile/ tablet compatible interfaces that can be used in different circumstances.

#### **Customisability** 

No two manufacturing processes are the same. An EBR system should be customisable and meet the specific needs of an organisation’s workflow. Businesses must be able to customise workflows, reports, and user permissions without needing to code anything or rely heavily on customer support. 

#### **Support & maintenance**

Providers should offer support plans that include timely updates, bug fixes, and lots of user support. Your team should feel in good hands, with a support team that has extensive technical knowledge not just of the system but of manufacturing processes more generally. 

Likewise, the vendor should be continuously improving their solution with regular updates and improvements that make life easier — the product shouldn’t feel stagnant or outdated. 

#### **Reporting and analytics**

Being able to generate reports and perform detailed analytics is another hallmark of a a great EBR system. This includes real-time data visualisation and the ability to track performance metrics. Nowadays this kind of thing is standard for most systems. So a provider should go above and beyond basic visualisations and allow you to really build whatever you aim to track. 

# EBR system comparison

## 1. MasterControl 

MasterControl specialises in solutions for pharmaceutical and other regulated industries, offering solutions for manufacturing and quality control. One of the products they offer is MasterControl EBR.

#### **Key features:**

* Simplifies compliance with audit-ready EBRs, accessible from anywhere
* Integrates with other enterprise systems
* Connects SOPs, training, specifications, and quality events for traceability

#### **Technical specifications:**

* Complies with FDA cGMP.
* Integrates with ERP systems for increased data accuracy
* Mobile-friendly dashboard for real-time data access

#### **Pros:**

* Reduces manual error 
* Better data integrity 
* Real-time insights.

#### **Cons:**

* Complex to use 
* Costly for smaller setups

![A chart showing MasterControl EBR's rankings on 7 key metrics: scalability, integration, UX, customisation, support, compliance and reporting & analytics. This is shown on progress bars with red as poor performance for that metric, yellow as average, and green as excellent. ](media/screenshot-2024-04-15-at-16.32.03.png "MasterControl EBR evaluation.")

## 2. Veeva Systems

Veeva Systems offers a Batch Release solution, a platform designed for enterprises in industries including pharmaceuticals, biotechnology, and CDMOs. Introduced in 2023, it automates the aggregation, review, and traceability of batch-related data and content. 

#### Key features:

* End-to-end solution for faster and more confident GMP release and market shipment decisions
* Integrates data and content from QMS, LIMS, ERP, and Vault RIM, for easier collaboration with external partners.
* Streamlines batch release processes

#### Technical specifications:

* Requires QMS and is typically integrated with Vault QualityDocs and LIMS
* Designed to work best when integrated with Veeva’s QMS, QualityDocs, LIMS but it can also interface with third-party solutions.

#### **Pros:**

* Majes complex processes easier to manage 
* Compliance with GMP

#### **Cons:**

* High dependency on other Veeva systems, which may limit flexibility for those using more third party systems.

![A chart showing Veeva Systems EBR's rankings on 7 key metrics: scalability, integration, UX, customisation, support, compliance and reporting & analytics. This is shown on progress bars with red as poor performance for that metric, yellow as average, and green as excellent. ](media/screenshot-2024-04-15-at-16.17.55.png "Veeva Systems EBR evaluation")

## 3. Ideagen

Ideagen provides information management software that helps companies with compliance, regulatory, and risk management, particularly in highly regulated industries like aviation, financial services, and life sciences.

#### **Key features:** 

* Audit management
* Document control
* Process mapping tools.

#### **Technical specifications:** 

* Can integrate with existing IT infrastructure  
* Scalable enough to meet the needs of large enterprises.

#### Pros: 

* Strong emphasis on compliance and risk management
* Good customer service
* Highly adaptable software which can be used for many different industrie

#### **Cons:** 

* The user interface requires a steep learning curve
* Initial setup can be resource-intensive, with lots of upfront investment and training

![A chart showing Ideagen EBR's rankings on 7 key metrics: scalability, integration, UX, customisation, support, compliance and reporting & analytics. This is shown on progress bars with red as poor performance for that metric, yellow as average, and green as excellent. ](media/screenshot-2024-04-15-at-16.18.05.png "Ideagen EBR system evaluation")

## 4. Tulip 

Tulip offers a digital solution for electronic device history records (eDHR/ eBR) for managing compliance processes and making sure there is accuracy in documenting device history records.

#### **Key features:**

* Track materials and automate data collection.
* Intuitive interfaces with work instructions.
* Regulation-compliant electronic signatures and GxP-ready functionalities.

#### **Technical specifications:**

* No-code app editor for creating digital batch records.
* Compatible across mobile devices, computers, edge devices, and wearables.
* Integrates with machines, sensors, and smart tools.

#### **Pros:**

* Improves production traceability.
* Better quality management, with reduced defects and compliance issues.

#### **Cons:**

* Requires initial training to make the best use of the tools.
* Might be overly customisable as the initial set-up could be initially difficult. 

![A chart showing Tulip EBR's rankings on 7 key metrics: scalability, integration, UX, customisation, support, compliance and reporting & analytics. This is shown on progress bars with red as poor performance for that metric, yellow as average, and green as excellent. ](media/screenshot-2024-04-15-at-16.18.16.png "Tulip EBR system evaluation")

## 5. 🌟Opvia 🌟

Opvia’s cloud platform simplifies how organisations manage and execute GxP procedures, integrating every step and data point across the product lifecycle. By digitising procedures, the platform automates compliance and data workflows, making it easier to maintain standards and efficiency.

#### **Key features:**

* Integrates with an extensive range of devices, systems, & tools, including, laptops, tablets, and third-party software solutions. 
* Offers powerful no-code tools that allow users to tailor solutions to their process needs without extensive programming.
* Provides end-to-end solutions to connect the entire product life-cycle e.g. ELN, LIMS, QMS, MES etc. 

#### **Technical specifications:**

* Universal compatibility with any screen size. 
* GxP-ready platform and fully compliant with all relevant regulatory standards.

#### **Pros:**

* Highly intuitive interface designed for ease of use.
* Each solution can be customised to specific organisational needs,
* Extensive support and training with Opvia’s customer success team, including on-site training.
* Advanced analytics and visualisation to transform data into actionable insights.

#### **Cons:**

* Tailored setup requires initial planning to ensure an optimal fit with specific manufacturing goals.

EBR system comparison: Top 5 solutions for 2024

Many manufacturers who have already implemented an Electronic Batch Record (EBR) system may believe they're well-on the path to digitisation and greater efficiency.

Many manufacturers who have already implemented an Electronic Batch Record (EBR) system may believe they're well-on the path to digitisation and greater efficiency. However, it's common for these manufacturers to feel they're not getting the most out of these systems. There may be a lingering feeling that despite their high-tech adoption, the magical 10,000% gains in efficiency that they dreamt of haven't quite materialised.

This is a common scenario. Even with the adoption of digital systems, many manufacturers may still be unsure on how to make the most out of their solution. They may feel that their EBR provider doesn’t offer adequate support or guidance on how to optimise their processes.\
\
The obvious answer is clear: make sure to pick the right EBR and make sure that your vendor offers extensive user support and consultations for process optimisation. But beyond this advice, this article is for teams that want actionable steps for improving their EBR workflow. 

# What is an EBR workflow?

An Electronic Batch Record (EBR) workflow is a digital process which involves  capturing and managing data and documentation during the manufacturing of goods. This kind of advanced workflow is essential in regulated industries with high levels of quality control and compliance, like pharmaceuticals, biotech and the food & beverages. 

If you’re confused about what an Electronic Batch Record is we suggest you start off by reading our brief guide on [What is a batch manufacturing record? A brief overview](https://www.opvia.io/learning-center/what-is-a-batch-manufacturing-record-a-brief-overview). It covers a lot of the basics that are helpful to know. 

## Key steps of an EBR workflow

Traditional batch records, usually documented with paper-based systems, need lots of manual entry, review, and physical storage space for manufacturing process data. This isn’t just time-consuming but often prone to human error. 

However, EBR workflows digitise and automate all these manual processes. The key steps of an EBR workflow include:

1. **Automated data capture**: the system directly interfaces with manufacturing equipment & sensors to automatically capture critical process data in real-time.
2. **Compliance checks**: They automatically validate data against predefined criteria and standards, making sure all the information meets regulatory standards. This is essential for compliance with standards like the FDA’s 21 CFR Part 11 (U.S.), which regulates the use of electronic records & signatures.
3. **Review and approval**: EBR systems automatically route documents to the appropriate personnel for review and approval. This workflow routing allows for faster decision-making and makes sure that no steps are missed in the manufacturing and quality assurance process.
4. **Audit trail**: EBR workflows create a detailed, time-stamped audit trail of all the activities and changes made to a batch record. This simplifies audit preparation so that it’s easier to show compliance with regulatory standards.

![Diagram showcasing the daily use of an Electronic Batch Record (EBR) system in the manufacturing process, depicted in a sequential workflow starting with 'Data Capture and Recording', moving through 'Compliance and Quality Checks', 'Review and Approvals', 'Audit Trail and Documentation', 'Analysis and Reporting', and culminating in 'Batch Release', to illustrate the EBR system's operational flow.](media/screenshot-2024-04-10-at-13.53.41.png "EBR workflow ")

## Benefits of streamlining your EBR workflow

Clearly, this is a step up already if a manufacturer has upgraded their processes from traditional systems like paper, spreadsheets or Sharepoint to a digital system like an EBR. But what are the benefits of streamlining your EBR workflow? Some benefits include:

* **B﻿etter compliance and audit readiness**
* **I﻿mproved operational efficiency**
* **C﻿ost reduction**

You can read how Opvia’s platform helped dramatically [improve both quality control and manufacturing efficiency in dietary supplement manufacturing](https://www.opvia.io/resources/quality-wellness-case-study) for a customer.  

# How to improve workflow efficiency

## 1. Identify bottlenecks

A good place to start when trying to identify bottlenecks and places where you can improve your workflow is to get a good understanding and overview of what exactly your workflow looks like currently. Here’s some strategies for how you can identify some bottlenecks faster:

* **Process mapping**: use process mapping tools to visualise your entire EBR workflow. This can help in finding issues, compliance gaps, and redundant steps clearly.
* **Utilisation analysis and time studies**: [time studies](https://datamyte.com/blog/manufacturing-time-studies/) can help in measure the duration of each step in the EBR process, pointing out exactly how long each stage of production takes.
* **Work-in-process (WIP) analysis**: High levels of WIP at certain stages of your workflow can indicate where there’s drag.
* **The “5 Whys” Technique**: Use the [“5 Whys” technique](<https://www.lean.org/lexicon-terms/5-whys/#:~:text=5%20Whys%20is%20the%20practice,working%20(Ohno%201988%2C%20p.>) by asking why five times and diving deeper with each question. This can help narrow down the root cause of congestion.

### Common bottlenecks in EBR Workflows

There are often recurring and common issues that we see manufacturers are struggling to optimise their workflows. These include issues like:

* **Outdated software systems**
* **Manual data entry processes**
* **Inadequate integration with other systems**

Your EBR system may not be up-to-date and may not support efficient workflow management, or may be incompatible with newer technologies. This can really slow you down and kind of defeat the whole purpose of actually having an EBR. Lack of integration between EBR systems and other business systems (e.g. ERP, MES, or LIMS) frequently can cause data discrepancies and blatant inefficiencies. Likewise, if you’re relying on too much manual entry, you obviously increase the risk of errors and slow down processes.

### Redundant steps 

Redundant steps can eat up huge amounts of unnecessary time and resources. Identifying and eliminating these is crucial. Here’s how you can do this:

* **Review your EBR process flow**: run a comprehensive review of your workflow to identify any unnecessary steps that do not add value to the process. Look for steps with repeated data entry or approvals.
* **Use automations**: If you’re running into repetitive tasks within the EBR process, like data validation or report generation, try to automate them!

## 2. Reduce waste

### Minimise documentation errors

Documentation errors can lead to loads of inefficiencies, reducing these is crucial for improving your workflow. A good place to start is with regular system audits, by periodically auditing the EBR system to understand sources of recurring documentation errors. You can then use audit trails to trace errors back to their precise source. 

It’s also important to have data validation protocols established. Having real-time data validation checks within your EBR system will help you correct errors. This can include range checks, format validations, and completeness checks.

Going even further, many manufacturers opt for automated data capture. Barcodes and scanners, for example, are used to automatically capture data directly from source materials, reducing manual entry errors.

### Shorten process reviews & approvals

Lengthy review and approval processes can also delay product releases. There are clear ways of reducing these areas of drag. 

Digital signatures can be very useful for instance. By using electronic signatures for reviewing and signing off on documents, manufacturers not only speed up their process but also improve document traceability.

Another common feature that many EBR systems, MES, and QMS offer is automated notifications. This feature allows you to set up automated alerts to notify relevant parties when review or approval is required so that documents move through the process without delay. 

Outside of these features, it can be useful to have role-based access controls for your EBR system. Defining clear responsibilities so that only authorised personnel can review and approve documents, can help manage and expedite these actions. 

### Applying lean manufacturing principles

[Lean manufacturing](https://www.techtarget.com/searcherp/definition/lean-production#:~:text=Lean%20manufacturing%20is%20a%20methodology,not%20willing%20to%20pay%20for.) (or just-in-time manufacturing) is “a methodology that focuses on minimising waste within manufacturing systems while simultaneously maximising productivity.”\
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Waste is seen as anything that customers do not believe adds value and are not willing to pay for.\
\
So how is this actually relevant and useful for EBR workflows? Lean manufacturing principles, when adapted to EBR workflows, focus on getting rid of any non-value-added activities. Here’s are a few lean principles that are actually actionable for these purposes:

* **Eliminate non-value-added steps**: identify steps that do not directly contribute to compliance or product quality. Either streamline or eliminate these steps.
* **Map the EBR value stream**: visualise the entire EBR process from start to finish to find areas of waste like redundant data entries or unnecessary reviews.
* **Create flow**: ensure that your EBR process flows smoothly without interruptions. Automate data transfers between systems where possible to reduce waiting times.
* **Establish a pull system**: rather than processing batch records in large batches, move to a system where records are processed as they are completed, based on demand. This reduces the backlog and improves cycle times.
* **Culture of continuous improvement**: try to foster an organisational culture of chasing perfection where feedback from users is actively sought and used to make incremental improvements processes. Regularly review the workflow for new opportunities to reduce waste.

![Circular cycle process flow diagram illustrating the core principles of lean manufacturing, starting with 'Identify Value', followed by 'Map Value Streams', 'Create Flow', 'Establish Pull Systems', and concluding with 'Seek Perfection', symbolising the continuous improvement process.](media/screenshot-2024-04-10-at-14.25.12.png "Lean manufacturing principles")

## 3. Automate routine tasks

We’ve touched on automation briefly already but there’s a lot more that we can zero in on in terms of identifying opportunities to speed up or smoothen manufacturing workflows. 

Data entry and capture is a good place to start. Clearly, tasks that involve repetitive manual data entry or data transfer between different systems should be automated.  Using [OCR (optical character recognition)](https://aws.amazon.com/what-is/ocr/) technology or integrations between systems can automate these tasks for data accuracy and time savings. 

Likewise, deploying [robotic process automation (RPA)](https://www.silvertouchtech.co.uk/blog/rpa-in-manufacturing-industry-benefits-use-cases-and-examples/) bots to handle repetitive tasks such as data entry, status updates, and simple decision-making processes, can also help to reduce manual workload.

Document generation can also be a pain, whether for generating batch records, quality reports, or compliance certificates. Instead of manually creating these, automatically generate documentation based on predefined templates and real-time data from production processes.

## 4. Employee training

Training a workforce on how to better make use of an EBR system can be a straightforward way of upgrading workflows. Well-trained staff are more likely to accurately enter data, follow procedures correctly, and spot areas of improvement, contributing directly to efficiency and reliability. 

### Develop a training program

Conduct a skills gap analysis to determine specific training needs in your organisation. Try to understand where teams are really struggling with using EBR software features.\
\
Develop tailored training materials for the unique needs of teams and the specific functionalities of the EBR system. Include real-world scenarios and common issues. This also might mean that you need to use a mix of training methods e.g. hands-on workshops, instructional videos etc.

### Leverage existing expertise 

An EBR system vendor, if they’re reputable, should offer lots of support and training (whether in the form of in-person training or educational resources) — don’t be afraid to take advantage of these! 

Similarly, organisations will have internal champions who have a deep understanding of your EBR workflows and regulatory requirements. These individuals can lead peer training sessions, offering insights based on their practical experience.

![Quiz interface on a digital training management system, testing manufacturing team's knowledge on workflow processes.](media/screenshot-2024-04-10-at-13.58.23.png "Training management system: quiz")

## 5. Integrating with other enterprise systems

Integrating your EBR system with other business systems is essential for making things run smoothly and for ensuring that no data is left inaccessible in siloes. Ideally, every single process – whether involving inventory, manufacturing or project management — should all be run on the same system. This way there is a unified view of data and processes. 

All-in-one platforms do exist and it’s best practice to use them, especially if an organisation needs to connect several different stages of the product life cycle from R&D all the way to quality assurance and distribution. 

But realistically, many businesses might not have the luxury of doing this for any number of reasons. So failing that, manufacturers should make sure that their EBR is capable of integrating with other systems. 

#### Some common integrations in manufacturing might include:

* [Inventory and supply chain management (SCM)](https://www.opvia.io/solutions/supplier-management)
* Enterprise resource planning (ERP)
* Manufacturing execution systems (MES)
* [Laboratory information management systems (LIMS)](https://www.opvia.io/solutions/lab-information-management-system-lims)
* [Electronic Laboratory Notebooks (ELN)](https://www.opvia.io/solutions/electronic-lab-notebook)
* [Quality Management Systems (QMS)](https://www.opvia.io/solutions/quality-management)

### Making use of APIs for integrations

APIs are what allow for system integrations by enabling different solutions to communicate. When considering integrating an EBR system with other enterprise solutions:

* **Choose API-friendly systems**: try to choose EBR solutions that offer well-documented APIs for easy integrations.
* **Security measures**: make sure all integrations via APIs adhere to strict security protocols to protect sensitive data. Ensure that you have authentication, encryption, and access controls.

# KPIs and useful metrics to know

There’s a lot that can be done to make these workflows run smoothly, but it’s hard to tell if tangible improvements have been made without being able to point to key metrics and numbers. 

## Calculating EBR workflow efficiency

Below is a formula for calculating EBR workflow efficiency. If you’re familiar with how to calculate [manufacturing efficiency](https://www.amper.xyz/post/manufacturing-efficiency-how-to-measure-and-improve-production) this isn’t too different.  

EBR workflow efficiency = (standard processing time / actual processing time) x 100%

* Standard processing time = the ideal time it should take to complete the EBR process without errors and with optimal performance.
* Actual processing time = the actual time it takes to complete the EBR process, including time spent on correcting errors, waiting for approvals, and any other inefficiencies.

So, for example, if an EBR process that should ideally take 10 hours takes 12 hours due to inefficiencies, the calculation would be (10 / 12) x 100% = 83.33%. This indicates there’s room for a 16.67% improvement in efficiency.

### Key Performance Indicators (KPIs) for EBR Workflow

But let’s delve a little deeper. EBR workflow efficiency can be broken down into specific areas: 

* Documentation errors 
* Process reviews and approvals

For reducing documentation errors, error correction rate (ECR) is good measure. This metric measures the percentage of documents that require corrections after initial completion.

ECR = (number of documents corrected / total documents processed) x 100%

Lowering the ECR involves implementing measures like the ones in this article such as automation or employee training. 

To measure process reviews and approvals, process cycle time (PCT) can be useful. This refers to the total time from the start of a process (e.g., document creation) to its completion (final approval).

PCT = End Time - Start Time

Reducing PCT can be achieved by automating approval workflows, setting crystal clear guidelines for document review stages, or using digital signatures to speed up the approval process.

### Additional KPIs for EBR workflow

Some other metrics that might be useful to keep track of for these purposes might be:

* Change Control Time
* Compliance Audit Readiness
* User Satisfaction Score (USS)
* Data Integrity Violations

How to improve your EBR workflow - step by step

For labs looking to make the jump from laboratory notebooks to electronic laboratory notebooks (ELN), it can seem like quite a big change. Increasingly, it’s becoming the norm to digitise lab records and procedures.

For labs looking to make the jump from laboratory notebooks to electronic laboratory notebooks (ELN), it can seem like quite a big change. Increasingly, it’s becoming the norm to digitise lab records and procedures. This is particularly crucial for labs in highly regulated sectors like pharmaceuticals and biotech where data integrity, accurate results, and accessibility to research is so essential. 

This article guides you through all the steps to smoothly transition to an ELN, with lots of specific tips to make things easier. This article covers:

* Defining success metrics
* Deciding on ELN requirements
* Organising existing notebooks
* Creating an implementation plan 
* Training staff 

## Assess your needs and set clear goals

Transitioning to an Electronic Lab Notebook (ELN) is a big move for labs in industries like pharmaceuticals or biotech, where the accuracy, integrity, and accessibility of research data are so important. The first, and most obvious, step in transitioning to an ELN is to nail down exactly what your organisation's goals and requirements are. 

### Identify functional requirements

We’ve actually written another article on this [which you can find here](https://www.opvia.io/learning-center/key-features-to-look-for-in-your-eln), but to give you the gist of it here are the most important parts to be aware of.

* **Regulatory compliance**: For labs operating in highly regulated sectors, compliance with standards like FDA 21 CFR Part 11 in the United States, [EudraLex Volume 4 Annex 11](https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en) in the European Union, and similar standards globally is a must.  

An ELN needs to offer features that ensure data integrity, audit trails, electronic signatures, and time-stamped records.

![A detailed table presenting the key standards, regulations, and guidelines for adopting Electronic Laboratory Notebooks (ELNs) across different regions. It includes the FDA 21 CFR Part 11 (USA), EudraLex Volume 4 Annex 11 (EU), ISO 27001 (global), and the global GLP (Good Laboratory Practice) for quality systems and study lifecycle management. Each entry explains essential features like audit trails, system validations, and data integrity.](media/screenshot-2024-03-26-at-14.35.43.png "ELN regulation, standards and guidelines")

**Pro Tip**: use a compliance checklist tailored to pharmaceutical or biotechnology research when evaluating ELN vendors. This checklist should cover aspects like data encryption, access control, and audit capabilities.



* **Integration with other laboratory systems**: Seamless integration with lab information management systems (LIMS), chromatography data systems (CDS), or other critical lab instruments & software is essential. ELNs are supposed to simplify and improve processes so it’s important that these integrations are able to connect your entire lab and support automated workflows.
* **Scalability and flexibility**: An ELN has to be scalable enough to handle large datasets and flexible enough to adapt to evolving research methodologies and projects.

Labs need to be able to move fast and deal with rapid shifts. Consider rapid shifts in research focus for many labs during the [development of COVID-19 vaccines ](https://covid19.nih.gov/nih-strategic-response-covid-19/decades-making-mrna-covid-19-vaccines)and treatments. ELN’s need to be flexible enough to support your unique research processes and scalable enough to grow with you.

![An infographic illustrating a checklist and flowchart for transitioning to an Electronic Laboratory Notebook (ELN). It starts with 'Requirements,' showing important considerations like location, industry, data types, and compliance with standards such as FDA CFR Part 11, ISO 27001, and EudraLex Volume 4 Annex 11. 'Features' shows core ELN features such as  electronic signatures and real-time collaboration. 'Integrations' covers relevant software and lab instrument integrations like LIMS, ERP, and eQMS. The 'Implementation' section outlines steps for setting-up an ELN, data migration, pilot testing, training, and onboarding.](media/screenshot-2024-03-26-at-14.30.50.png "electronic laboratory notebook checklist")

### Define Success Metrics

It’s important to know what your aims are with the adoption of an ELN. Is it to improve traceability? Have better access to data and lab results? Reduce compliance issues? Or is it just to digitise and modernise your lab? Whatever it is, you should define what results you hope to achieve.\
\
Here are some factors you might want to consider:

* Reduce data retrieval times
* Reduce regulatory compliance issues
* Increase accessibility to data, documents, and results

It’s also useful to try and benchmark the success of your ELN to assess how effective an asset it is and whether you are maximising its value. When benchmarking, try to make this as quantifiable as you can.

## Organise your existing notebooks and data

Begin by undergoing a detailed inventory of all data types documented in traditional paper notebooks. In pharmaceutical research, this may include not only experimental data and results but also observations, protocols, batch records, and quality control (QC) checks. 

This step is essential in terms of making sure everything is traceable as every data point could be necessary for regulatory scrutiny or patent filings.

Expert Insight: Use a systematic approach for cataloguing data. You should use a standardised taxonomy that is specific to your lab's specific research areas and regulatory compliance. For example, you could categorise data based on project codes, study phases (e.g., preclinical, Phase I-III), and data types (e.g., analytical, biological, chemical).

This step will not only help you evaluate your needs when selecting an ELN, but it will also make it much easier when actually migrating everything across to your new system.

Here are some more quick tips on naming existing data & documents:

* **Notebook titles**: Combine user initials, year, and project name (e.g., JDOE-2024-VaccineDev).
* **Page entries**: Format with experiment number, name, user initials, and date (e.g., 02-AntigenTest-JDOE-20240321).
* **File names**: Clearly state the experiment and data specifics (e.g., VaccineTrial1-Data.xlsx).

![A table within an experimental notebook. It is meticulously organised to show various compounds. Each row represents a different compound, featuring columns for Compound ID, a diagram depicting the molecular structure, the creation date, the supplier (e.g. Supplier A), and results from in-vitro assays and studies. This table format enables quick reference and comparison, helping in the management and analysis of compound data for research.](media/screenshot-2024-03-26-at-12.31.39.png "Detailed compound table in experiment notebook")

## Create an implementation plan 

When making the transition from laboratory notebook to ELN, it’s a good idea to come up with a clear plan of how this will be done and how long it will take. Your ELN system provider should technically be doing this for you and making the process as easy as possible. But failing that, it's helpful to know what you need to plan for. 

### Timeline and milestones 

Develop a clear timeline that spells out the key milestones in the ELN implementation process. For a biotech company, these milestones might include regulatory compliance checks, integration testing with existing lab instruments and systems, and pilot test phases that are coordinated with existing project cycles or even regulatory submission deadlines.

You should include buffer periods for unexpected delays, especially around phases that involve regulatory compliance verification or complex data migrations.

Try to be realistic about how long this transition will take. Account for data & document transfers, setting-up your new platform environment, and training your teams properly. If you have a particularly large organisation or complex processes, it can take upwards of 3 months with some vendors. 

### Regulatory approval gates

Include specific checkpoints for regulatory compliance validation, ensuring that your new ELN meets all necessary guidelines (e.g. FDA 21 CFR Part 11). 

### Assign roles and responsibilities

These kinds of changes can involve a lot for a company. So it can be helpful form a cross-functional team to oversee the ELN implementation.This team may be made up of employees from R&D, quality assurance, and regulatory affairs

Assign clear roles and responsibilities for all relevant personnel. You should ensure that there is clear ownership over all aspects of the transition.

Going further, it can also be useful to appoint a project manager or an IT specialist to manage system integration and technical issues.

### Pilot testing

Choose a small, diverse team to run the pilot test on. It should comprise of  researchers, lab technicians, and data analysts who are already engaged in a current, active research project. 

This group should represent a cross-section of your lab's operations, including those working on drug discovery, clinical trials, and quality control. This diversity helps ensure that the ELN is tested across a range of research activities and data types common in pharmaceutical and biotech labs.

Collect detailed feedback from all pilot group members, focusing on both the technical aspects of the ELN and its impact on daily research activities. Use this feedback to make informed decisions about broadening the ELN's rollout within the lab and to iterate on training and support structures to ensure wider adoption is successful.

## Training

Onboarding involves familiarising your team with an ELN system and training them to a point where they can easily navigate and use the system on a daily basis.

This may involve an initial training of one or two users, usually a team manager, to be a “super” user. This user would ideally be equipped with knowledge of how the platform works and can then disseminate knowledge about the system to the rest of the team. 

It’s also useful for the “super user” to have additional permission and controls which enables them to oversee and override all activities.

Make sure to take into consideration the timeline for onboarding. Users will need to be trained and be fully competent with the system. The onboarding process may be split into different phases which enables users to navigate different aspects of the platform. The onboarding process should act as a safety net and enables users to make “mistakes” and make any necessary changes to the platform to optimise their workflows.

![A diagram showing the data flow in a laboratory setting, starting with a scientist icon. The process flows from collecting instrument data, sample data, and inventory usage, into an ELN system. This system then spits out reporting, analytics, and collaboration, leading to insights for both management and scientific teams.](media/screenshot-2024-03-26-at-15.02.31.png "Laboratory data flow diagram using an ELN")

## Rely on Your Provider

One of the most valuable resources at your disposal is your ELN provider. Using their expertise and support services will smoothen the transition process and make sure that you’re getting the most out of your new system. 

Here’s how you can get the best guidance from your provider:

* **Use support services**: Your ELN provider should offer a range of support services, including consultations, technical assistance, and training. Make sure to take full advantage of these offerings not just when adopting your ELN but beyond the implementation phase. Whether it's troubleshooting technical glitches or helping you improve your workflow, the support services provided by your vendor can be invaluable.
* **Request customisations**: Each lab has unique workflows and preferences. Your ELN provider should offer customisations and build a solution around your needs, not the other way around. Whether it’s modifying templates, automating a step in a process, or integrating with different tools, don’t hesitate to discuss these needs.

Try to avoid one-size-fits-all solutions when selecting an electronic lab notebook. Generic templates, workflows, and systems tend to actually slow you down a lot more than more purpose-built solutions. So aim to find a system that doesn’t require you to adjust your practices to a stringent framework.

How to transition from a laboratory notebook to an ELN 

Batch manufacturing records (BMRs) are detailed documents that track every step of making a product in manufacturing plants. These files include what materials are used, the unique ID for each product batch, how long each part of the process takes, and the checks done to ensure the product is made correctly.

Batch manufacturing records (BMRs) are detailed documents that track every step of making a product in manufacturing plants. These files include what materials are used, the unique ID for each product batch, how long each part of the process takes, and the checks done to ensure the product is made correctly. BMRs also note when things don't go according to plan and what actions are taken to fix those issues. This kind of attention to detail helps make sure that every product is consistent in quality and safe for use.

BMRs are not just about keeping a close eye on production. They're also about following rules, specifically good manufacturing practice (GMP) standards. These standards are set to make sure products are made in a way that they are always safe and of high quality.

Understanding batch manufacturing records is [key for any company making regulated products or in the life sciences industry](https://www.ey.com/en_us/life-sciences/electronic-batch-records-improve-pharma-manufacturing). They help improve how products are made and ensure they meet the high standards expected by both customers and legal requirements. This article explains what goes into these records, how they're put together, and why they're so important for producing compliant and high-quality products. 

## Importance of batch manufacturing records

Batch manufacturing records play a crucial role in maintaining high standards in manufacturing. They are the backbone of quality control, making sure every product meets the strict criteria set for safety and performance.

These detailed records track the entire manufacturing process, from start to finish. By documenting each step of the production process, BMRs provide a clear roadmap of how a product was made. This is invaluable for identifying where things might have gone wrong if a product doesn't meet quality standards. In heavily regulated industries like pharmaceuticals or biotech this can have huge consequences. 

Consider a scenario where a batch of antibiotics fails to meet quality standards during testing. This could lead to [massive recall costs](https://www.pharmaceuticalprocessingworld.com/drug-recalls-2022-2023-contamination-sterility-concerns/) and regulatory fines, not to mention the potential harm to patients who rely on these medications.

However, by referring to the BMRs the manufacturer can pinpoint the exact stage where the issue occurred, whether it was an incorrect ingredient measurement or a deviation in the mixing process. This information is invaluable for identifying and correcting the problem to make sure that future batches meet the required standards. 

But BMRs are not just about spotting errors. They’re also essential for making process improvements. By analysing these records, manufacturers can find ways to make their processes more efficient and effective. In doing this, manufacturers who use batch manufacturing records are generally capable of optimising their processes more easily than companies that don’t. This often enables companies to create better products, save time and money. 

## Master Production Records v. Batch Production Records

When we talk about batch manufacturing records, there are two types of documents that are important to distinguish: [master batch records](https://www.plm.automation.siemens.com/global/en/our-story/glossary/what-is-a-master-batch-record-mbr/106448) and batch production records. It’s useful to understand what both refer to and how they’re different. 

A **master batch record** (MBR) is essentially the blueprint for producing a product. It outlines the ideal process, including detailed instructions for every step of production. This record sets the standard, specifying the exact raw materials, equipment, and conditions needed for manufacturing.

On the other hand, **batch production records** (BPR) are created for each individual batch of the product made. These records document how the batch was actually produced, noting any variations from the MBR and how they were handled. BPRs show the real-time history of each product batch, ensuring that it sticks to the established guidelines and quality standards.

## Key components of a batch manufacturing record

* **Raw materials**: Details about the materials used, including quantities and suppliers.
* **Bill of materials**: A comprehensive list of all items needed for production.
* **Batch number and lot numbers**: Unique identifiers for tracking each batch and its components.
* **Production including steps and timings**: A step-by-step account of the manufacturing process and how long each part takes.
* **Quality control checks and outcomes**: Results from tests and inspections to ensure the product meets quality standards.
* **Deviations from the standard procedure and corrective actions taken**: Notes on any variances from the MBR and the measures taken to correct them.

![The table summarises the different components of a batch manufacturing record. It has three columns: components, description, and example. It shows the list of components bullet-pointed above in organised in a table form, with examples like a bill of materials such as 10 kg of Penicillin G Sodium.](media/screenshot-2024-03-15-at-16.47.07.png "Examples of batch manufacturing record components ")

## Creating and maintaining BMRs

Creating and maintaining BMRs is a meticulous process. It begins with gathering raw materials, each carefully selected and documented for quality. As production kicks off, every step, from mixing to packaging, is recorded in detail. This includes noting the batch number for traceability and making sure every action adheres to predefined standards (i.e. the master batch record). 

Key checkpoints for quality control are embedded throughout this process. These checks confirm the product meets every specification before it moves to the next stage. Once production is complete, the final quality control checks are the last line of defence, verifying that the product is safe and ready for consumers.

However, accurate record-keeping extends beyond the manufacturing process. It also includes the licence number of the product, which is essential for regulatory compliance, and the expiration date, vital for consumer safety. 

![A visual timeline showing the key steps in the batch manufacturing record process, from start (raw material procurement) to finish (batch release). This is highlighted by relevant icons: test tube, clipboard, factory, magnifying glass, check mark, and box, respectively. Alongside, a continuous line with a pencil icon that signifies the ongoing record-keeping and documentation across the entire manufacturing process.](media/screenshot-2024-03-15-at-16.27.31.png "Timeline of batch manufacturing record process ")

## What is good manufacturing practise (GMP)? 

These records aren't just paperwork. They prove that products are made correctly, can be traced back through every step of their creation, and meet all legal and safety standards.

[Good manufacturing practice (GMP)](https://www.who.int/news-room/questions-and-answers/item/medicines-good-manufacturing-processes#:~:text=What%20is%20GMP%3F,controlled%20according%20to%20quality%20standards.) is a system for ensuring that products are consistently produced and controlled according to quality standards. The aim of these standards is to mitigate risks like contamination, mislabeling and inconsistencies in active ingredient concentration. These are based on the guidelines outlined by the World Health Organization (WHO). They stress the importance of having detailed, written procedures for every step of production, from the raw materials to the finished output. Many other countries and organisations have their own similar GMPs or have harmonised their standards with the WHO. 

GMP standards outline that manufacturers should keep track of information about:

* **Raw materials used** 
* **Operational parameters**
* **In-process controls** 
* **Personnel involved**

BMRs are a direct application of GMP standards. They take GMP guidelines and translate them into a documented narrative of the production process for each batch of product. 

Batch manufacturing records often take these standards several steps further. Opvia provides a unified platform for manufacturing technicians and operators to build workflows that suit their individual organisational or team needs.

What is a batch manufacturing record? A brief overview  

An electronic quality management system (eQMS) digitises how quality control is managed. It replaces paper-based systems with digital systems, integrating record-keeping, workflow automation, and quality checks into one platform.  One of the key features of an eQMS is its database which simplifies tasks like document tracking and audit management, whilst making sure that standards like ISO and FDA regulations are being met.

An electronic quality management system (eQMS) digitises how quality control is managed. It replaces paper-based systems with digital systems, integrating record-keeping, workflow automation, and quality checks into one platform. 

One of the key features of an eQMS is its database which simplifies tasks like document tracking and audit management, whilst making sure that standards like ISO and FDA regulations are being met. These systems enable manufacturers to better handle quality issues, corrective actions, and improve product standards. Equipped with real-time analytics, an eQMS can also help companies cut waste and refine their processes.

This article will break down the basics of eQMS, explaining how they work, their benefits, and their importance in product manufacturing.

## Limitations of paper and spreadsheets

Many companies still rely on manual or paper-based record-keeping to track quality controls, a process that is very time-consuming and prone to errors. These paper-based systems require extensive physical storage, make it challenging to retrieve specific information quickly, and are just inefficient.

### Many labs and manufacturers still struggle with cluttered paperwork…

Reliance on paper for record-keeping results in serious limitations. Paper records are not just susceptible to physical damage like water, crumpling, or just being misplaced but also are incredibly inefficient for organising large amounts of information or remaining compliant. Likewise, updating these paper records is slow-moving, resulting in outdated or conflicting versions of documents.

![An image showing 4 different SOPs, documents, and procedures that highlight the inefficiency and clutter resulting from paper-based records. The visual disarray of physical documents, illustrates how paperwork is chaotic, inefficient, and difficult-to-manage. ](media/screenshot-2024-03-15-at-17.23.41.png "Paper-based document, procedures, and SOPs")

### … Or risk accuracy mistakes with overwhelming spreadsheets

While spreadsheets are a step up from paper in terms of digitisation, they come with their own set of problems. First off, they lack real-time collaboration features, leading to multiple versions of the same document and confusion over which one is the most up-to-date. They're also prone to human error: a simple typo can have far-reaching consequences, skewing data analysis & leading to inaccurate results. Spreadsheets are also limited in their ability to manage complex relationships between data points, making them unsuitable for tracking intricate quality control processes across multiple products or locations. 

![An image showing the challenges and inefficiencies of using manually filled spreadsheets for managing quality control. It depicts several spreadsheets with overwhelming amounts of data and lots of entries with errors, emphasising how such spreadsheets can lead to inaccuracies, inefficiency, and poor performance. The visual suggests that relying on difficulty to manage, error-prone spreadsheets are very inefficient. ](media/screenshot-2024-03-15-at-17.24.02.png "Drawbacks of spreadsheets for quality management")

## What is an eQMS?

An electronic quality management system (eQMS) digitises quality control processes, replacing paper and spreadsheets. It integrates record-keeping, workflow automation, and quality checks into a single digital platform.

A key feature of an eQMS is its database, which enables document tracking, audit management, and compliance with standards like ISO and FDA regulations. An eQMS system helps manufacturers address quality issues, manage corrective actions, and monitor product standards.

An eQMS offers a cleaner and more accessible way of overseeing quality management, from document control and training to audits and supplier management. Not only does this improve efficiency but also enables greater accuracy and traceability. Manufacturers can instantly access and analyse their data, identify trends, and conduct corrective actions more quickly.

## QMS v. eQMS

A **[quality management system](https://asq.org/quality-resources/quality-management-system)** (QMS) is a set of procedures and guidelines a manufacturer follows to ensure its products and services meet quality standards & customer expectations. It's a structured way of doing things that shows how to make products the right way, making sure customers are satisfied and everything complies with laws and regulations.

An **electronic quality management system** (eQMS) is the digital version of a QMS. It takes all those guidelines and procedures and puts them into a software solution. This makes it easier to manage because everything is in one place, accessible from anywhere, and it reduces paperwork. The big difference is that an eQMS uses technology to streamline and improve quality control processes. The distinction can be useful to understand, but often when someone refers to a QMS they are actually referring to an eQMS. So the terms may be used interchangeably.

![Flowchart showing the quality control process. It begins with the Quality Manager who oversees quality events, documents, training records, and audit findings. These components flow into an electronic quality management system (eQMS) that enables reporting, visualisation, collaboration, and management through a relational database. The process then flows out to the management team, the Quality Manager, and auditors. This highlights shows the quality control process while using an eQMS.](media/screenshot-2024-03-15-at-17.37.01.png "Flowchart of using the quality control process using an eQMS")

## Key features of an eQMS

What’s included under the term eQMS can be quite varied. For example, sometimes an eQMS can also include features that are more commonly associated with [Electronic Batch Records](https://www.opvia.io/solutions/electronic-batch-records-(EBR)). 

Generally speaking though, common features of an eQMS include:

* **Document management**
* **Training management**
* **CAPA (Corrective and Preventive Actions)**
* **Audit management**
* **Risk management**

However, these are really just the most basic features that you can expect with an eQMS. Top-tier providers should offer more widespread and comprehensive capabilities like:

* **Version control**
* **Automated workflows**
* **Advanced analytics & reporting**
* **Integrations with other tools**
* **Complaints management**
* **Inventory and supplier quality management** 

![Table summarising key eQMS features that are listed above, such as document management, training management, CAPA, audit management, and risk management. Examples are provided, such as organising research trial reports and scheduling GLP courses. This illustrates the practical applications of the different features for a quality manager. ](media/screenshot-2024-03-15-at-17.36.43.png "Key features of an eQMS")

## Benefits of implementing an eQMS

From a high-level view, an eQMS can be useful in improving how enterprises manage quality, compliance, and product development. 

One such benefit is **real-time data access**. In regulated industries, like the pharmaceutical industry, real-time data access allows for immediate visibility into the production process. For instance, if a batch of medication shows unexpected results during quality checks, an eQMS instantly alerts the quality team. They can then quickly investigate and implement changes or halt production if necessary, preventing both potential health risks and financial loss. The immediacy of this kind of oversight makes sure that every decision is informed by live data.

An eQMS can also **automate the tracking and management of compliance documents**, like safety standards and allergen controls. For food manufacturers, for example, regulatory compliance is a must. So when a food safety inspector requests documentation during an audit, the manufacturer can instantly provide comprehensive records, showing transparent compliance with regulations like the FDA’s Food Safety Modernisation Act. This not only makes the audit process easier to manage but also greatly reduces the risk of violations and recalls.

In terms of product development, an eQMS can significantly **improve the efficiency of processes**. Companies like medical device manufacturers are highly regulated, requiring rigorous testing and documentation to make sure their products are safe for patient use. An eQMS enables a company to have a centralised platform where design, engineering, and quality teams can collaborate efficiently rather than the different stages of the product life-cycle being siloed. 

For instance, if a prototype device fails to meet the required biocompatibility standards during testing, the test results and feedback are immediately available within the system. Engineers and designers can then access this information, understand the shortcomings, and make changes to the design. Again, this kind of direct and real-time procedure can accelerate the development process, whilst also ensuring compliance with regulatory standards like those set by the FDA or EMA. It’s no surprise then that MedTech companies that use eQMS have shown a reduction in the time it takes to bring new, safe medical devices to market.

## Selecting an eQMS

Not all eQMS solutions are created equal. Many suffer from poor user interface designs that are not intuitive, making them difficult to use and leading to low adoption rates within an organisation. Others may be overly rigid, offering little to no customisation, which means they can't adapt to the specific workflows or regulatory requirements of different industries. Many eQMS solutions struggle with basic integration issues, unable to connect with other critical software tools within an organisation, which ultimately defeats the purpose of an eQMS with siloed data and more inefficiency. 

Selecting the right EQMS software also requires careful consideration to ensure it aligns with an organisation's unique needs. When evaluating solutions, focus on the specific features that support your enterprise quality management goals. An eQMS with robust document management and CAPA features is essential for maintaining high compliance & quality standards.

**Scalability** is another factor. As your business grows, your eQMS should easily adapt to this growth, accommodating more users, processes, and data without compromising performance. Many startups or small businesses start with a small team and a handful of processes but often need to scale up their production and team as they grow. Your eQMS software must support this growth seamlessly.

**Integration capabilities** are equally important. The best eQMS software should smoothly integrate with other systems you already use, such as ERP (enterprise resource planning) or CRM (customer relationship management) platforms. Data needs to be able to flow freely between different systems otherwise it becomes siloed and impossible to work with. 

## Compliance with FDA CFR Part 11

For labs or manufacturers looking to adopt an eQMS, picking the right one can be tricky. A key thing to keep in mind for any eQMS buyer, especially in life sciences or other regulated industries, is the system's compliance with [FDA 21 CFR Part 11 ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application)regulations (for the USA). 

This rule governs the use of electronic records and electronic signatures, setting standards for their acceptable equivalent to paper records and handwritten signatures. It’s important to be sure that the system you use for managing your digital records is both appropriate and legal. Using a makeshift or outdated system that doesn't meet these standards, for example, could end up in non-compliance issues, risking failed audits, and large fines.

Other regions have similar guidelines and standards to the US’s 21 CFR Part 11. The European Union’s Annex 11 guidelines and global standards like [ISO 27001](https://www.techtarget.com/whatis/definition/ISO-27001) offer equivalent regulations for managing electronic records and signatures.

When looking into eQMS that is compliant with these standards, key aspects buyers should focus on include:

* **Security and access controls**
* **Electronic signatures**
* **Audit trail capabilities**
* **Data integrity and reliability**

What is an electronic quality management system (eQMS)?

Edinburgh, Scotland – Ingenza, a dynamic CDMO and leader in engineering biology, is pleased to announce its strategic partnership with Opvia, a Quality Management Systems (QMS) provider.

Edinburgh, Scotland – Ingenza, a dynamic CDMO and leader in engineering biology, is pleased to announce its strategic partnership with Opvia, a Quality Management Systems (QMS) provider. This partnership is driven by Ingenza's commitment to enhance and centralise its quality management processes, with a focus on precision and operational efficiency.

Opvia's QMS solution will serve as a robust platform for Ingenza, enabling the seamless integration and management of its quality management practices. This strategic decision aligns with Ingenza's continued dedication to maintaining excellence across its operations, spanning microbial strain and mammalian cell-line engineering, protein production, fermentation, and bioprocess development.

Ingenza CEO Ian Fotheringham commented, “We have been delighted with the rigour and agility shown by Opvia in providing Ingenza with a robust eQMS that fully supports our process development and biomanufacturing operations”.

This collaboration underscores Ingenza's proactive approach to quality management and its steadfast pursuit of operational excellence. With Opvia's proven QMS solution, Ingenza is well-equipped to not only meet but exceed the stringent quality standards demanded by the biotechnology industry.

Opvia's suite of quality management tools offers streamlined quality processes, centralised data management, end-to-end process visibility, automated workflows and notifications, compliance and audit readiness, and data-driven decision making.

# About Opvia:

Opvia is a leading provider of R&D, manufacturing, and quality control solutions, offering tailored systems to organisations in regulated industries. Opvia empowers companies in the life sciences, chemicals, and manufacturing industries to digitise and optimise their laboratory and manufacturing operations, ensuring compliance, efficiency, and data integrity.

Committed to advancing the frontiers of research and development, Opvia continually tailor its solutions to meet the specific needs and workflows of its partners.

# About Ingenza:

[Ingenza](https://www.ingenza.com/) is a dynamic CDMO providing preclinical and process development services through to first-in-human manufacturing. Ingenza’s understanding of nature, combined with a unique engineering biology toolbox, accelerates customer products through key milestones to commercial success. Its scientific and commercial activities are led by a management team with over 60 years’ experience in applied bioscience and the development and commercialisation of bio-based products.

Ingenza selects Opvia as its QMS provider to elevate biotech innovations

How can my company deliver peak productivity, high product quality, and strong compliance with industry standards? How can I simplify the complexities of internal policies, processes, and procedures? These are common questions that come up to those in quality management or compliance.

How can my company deliver peak productivity, high product quality, and strong compliance with industry standards? How can I simplify the complexities of internal policies, processes, and procedures? These are common questions that come up to those in quality management or compliance. Here are 5 important tips to create a comprehensive QMS for your organisation.

## 1. Define Your Quality Objectives

Quality objectives, which are essential for QMS implementation, establish measurable value standards, holding your organisation and employees accountable. These objectives can range from department-specific to product-specific, such as minimising defects, enhancing efficiency, improving performance, and ensuring reliability. Clear quality objectives are the bedrock of a successful QMS. It is also important to ensure these objectives are very visible, whether in a centralised dashboard or through regular reporting. 

## 2. Set Up Your Training Needs

To meet quality requirements, employees must be well-versed in your QMS policies and procedures. Overlooked adherence to these guidelines is a common quality plan flaw. Regulatory audits often focus on training records, making effective training essential. A streamlined approach is developing a training matrix, which can be broken down into steps:

* **Employee Grouping:** Start with categorising employees into groups based on department and job titles, then add associated descriptions. This grouping forms the foundation of your training matrix. It is also important to identify supervisors and subordinates within your employee groups to ensure that there's a clear line of communication and responsibility within your organisation.
* **Link to Policies and Procedures:** Connect the information from your employee groups, job descriptions, and hierarchy with your organisation's Standard Operating Procedures (SOPs) and policies. 
* **Customised Training Curriculum:** Create a training curriculum tailored to each job title. This curriculum should cover the specific skills, knowledge, and procedures required for each role.
* **Tracking and Notifications:** Make sure you have a system that tracks training completion and sends notifications about updated training materials, ensuring that your workforce remains up to date and compliant.

## 3. Continually Monitor Activities to Improve Your Performance

Regularly validating your QMS is crucial. It involves reviewing your service delivery or product quality against predefined standards. Inspection at the source helps catch errors before reaching customers and allows process refinements. Key considerations include:

* **Adherence to Quality Objectives:** Ensuring that your processes align with the initially defined quality objectives and standards is fundamental to maintaining product and service quality.
* **Process Effectiveness:** Measuring the effectiveness of pre-determined processes and confirming compliance with relevant standards and regulations is crucial to meeting quality standards.
* **Areas for Optimization:** Identifying opportunities for streamlining and improving processes to enhance efficiency and quality is key to achieving operational excellence.

This continuous validation and review process ensures that your organisation remains agile and committed to delivering consistent quality.

## 4. Employ Corrective and Preventive Actions (CAPA)

Corrective and Preventative actions are improvements to an organisation’s processes to reduce the number of deviations from the given specification and other issues that arries.

Building a good CAPA process is key to generating a useful and robust QMS process. 

A good CAPA process consists of 4 main steps

* **Identify deviations:** Quickly spot deviations from your established standards by tracking your manufacturing processes and appropriate quality metrics.
* **Root cause analysis:** Once found determine the main factors behind the deviation.
* **Take corrective actions:** Implement immediate solutions to address the identified issues
* **Produce preventive actions:** Make changes to your existing processes to reduce the risk of similar issues happening again.

A good CAPA process will reduce the number of deviations from your established standards and is a vital part of any QMS process.

## 5. Provision a quality management solution

Now your process is defined, it's time to set it up. It is possible to manually track employee training and other aspects of your quality control system. However, moving your processes into a purpose built Quality Management Solution (QMS) provides robust levels of control and will help streamline and improve the process.

Software such as Opvia allows your to manage aspects of your quality control processes such as

* **Build training materials:** Easily build comprehensive training materials including tests and videos.
* **Change controls:** Track and get approvals on change requests.
* **Manage training:** Specify training requirements. Test understanding and see reports of each staff member’s progress through your training material including tests. Easily generate training matrices.
* **Notifications:** Get notified when a process is changed.
* **Weekly reports:** Generate automated weekly reports to highlight key areas for improvement using bespoke metrics.
* **CAPA management:** Create corrective actions. Implement preventive actions along with associated training materials.
* **Keep your SOPs in one place:** make it easy for your employees to see all SOPs relevant to them including any changes.

Using a dedicated quality management system greatly improves the efficiency of your QMS and has been shown to greatly improve levels of compliance and training while also reducing the impact of quality-related incidents.

Implementing a quality management system is a significant step in improving the quality and efficiency of your products and manufacturing processes. While it is possible to do it alone, having an expert to hand can be a big help. Opvia customers are provided with a customer experience representative who is an expert in identifying the key requirements across a number of industries. 

Read about how Opvia’s software can support your QMS needs [here](https://www.opvia.io/) and sign up for a demo [here](https://www.opvia.io/contact).

5 Tips to Implement a Quality Management System

In the dynamic and highly regulated fields of biotechnology and pharmaceuticals, ensuring product quality is of paramount importance. A robust quality management system (QMS) is a fundamental component of this endeavour, offering a structured approach to guaranteeing that every aspect of product development, manufacturing, and distribution meets the highest standards.

In the dynamic and highly regulated fields of biotechnology and pharmaceuticals, ensuring product quality is of paramount importance. A robust quality management system (QMS) is a fundamental component of this endeavour, offering a structured approach to guaranteeing that every aspect of product development, manufacturing, and distribution meets the highest standards. In this article, we delve into why quality management systems are essential, guided by recent studies including "A Study on the Effect of Quality Management Systems on Organisational Productivity (Movahedi 2013)", and what features to look for when choosing a QMS.
## The Importance of Quality Management Systems
**Regulatory Compliance**
One of the primary reasons clients in the biotech and pharma sectors need a QMS is regulatory compliance. Both industries are subject to a myriad of regulations and standards imposed by health authorities, such as the FDA (Food and Drug Administration) in the United States and the EMA (European Medicines Agency) in Europe. A QMS serves as a systematic approach to adhere to these regulations, ensuring that all necessary processes and procedures are followed to meet compliance requirements.

**Risk Management**
The biotech and pharma industries are inherently fraught with risks. A quality management system provides a structured framework for identifying, assessing, and mitigating these risks. This proactive approach helps in preventing errors, deviations, and adverse events that could lead to product recalls or, in extreme cases, harm to patients.

**Product Quality Assurance**
Ultimately, the key objective of a QMS in biotech and pharma is to ensure product quality. Clients in these industries rely on their reputation for producing safe and effective products. A good QMS establishes quality as a fundamental tenet, ensuring that products consistently meet predefined quality standards. This not only builds trust with stakeholders but also ensures patient safety.
## Key Components of a Good Quality Management System

**Documented Procedures**
A well-documented QMS consists of comprehensive procedures for all aspects of the business, including research, development, manufacturing, testing, and distribution. These procedures should be easily accessible to employees and regularly updated to reflect current practices and standards.

**Training and Competence**
Employees are a crucial part of any QMS. A good system includes processes for training and assessing the competence of personnel. This ensures that employees understand their roles, responsibilities, and the quality standards that must be maintained.

**Change Control**
In a dynamic field like biotech and pharma, change is inevitable. A good QMS should have a well-defined change control process in place to assess, approve, and document changes to processes, products, or systems. This ensures that changes are made in a controlled and compliant manner.

**Document Control**
Document control is essential to maintain the integrity and traceability of records, including standard operating procedures (SOPs), batch records, and other critical documents. A good QMS provides strict control over document creation, review, approval, and retention.

<div style="position: relative; padding-bottom: calc(54.625850340136054% + 41px); height: 0; width: 100%"><iframe src="https://demo.arcade.software/s18HvCavZK9v0gM4Ze4C?embed" frameborder="0" loading="lazy" webkitallowfullscreen mozallowfullscreen allowfullscreen style="position: absolute; top: 0; left: 0; width: 100%; height: 100%;color-scheme: light;" title="Document control | Opvia Staging"></iframe></div>

**Conclusion**
For clients in biotech and pharma, the adoption of a quality management system is not an option but a necessity. It ensures compliance with stringent regulations, fosters consistency and standardisation, and prioritises patient safety and product quality. A good QMS comprises documented procedures, risk management, competent personnel, and mechanisms for change control and continuous improvement. By embracing a strong QMS, companies in these industries can achieve their mission of providing innovative, safe, and effective products while mitigating risks and maintaining a competitive edge in the market

To truly unleash the potential of Quality Management Systems in the biotech and pharma sectors, look no further than our industry-leading QMS software. Our team is dedicated to supporting your organisation's journey towards excellence, offering you the tools needed to stay competitive and innovative while meeting regulatory standards. Join us, and experience a new era of QMS efficiency, precision, and success. Your success is our mission!


What are the requirements for your specific business? Will the system be compatible with your existing hardware and software? How user friendly is the interface? These are just a few of the questions you'll need to answer before making a decision to switch to an electronic batch recording system.


What are the requirements for your specific business? Will the system be compatible with your existing hardware and software? How user friendly is the interface? These are just a few of the questions you'll need to answer before making a decision to switch to an electronic batch recording system.

Here is a list of the factors to consider before making that decision.

### Scalable to support growth

The electronic batch record system should be scalable to support growth. Making sure the chosen system is able to handle multiple users, has a user-friendly interface, and can generate reports quickly and easily. And if expanding into new markets, making sure the system is able to accommodate different languages and currencies is important.

### Configurable to support changing business needs

As the business grows and changes, the batch record system must grow and change. That's why it's important to choose a system that's configurable—so it can be adapted to specific needs.

The system should be able to capture all the data, from production through shipping. Most importantly, it should be reliable with reliable batch records.

### Real-time data capture and analysis

Capturing data in real-time is vital to be able to track the progress of the batches and make sure that they're staying on schedule.

A system that provides analysis and reporting functionality is useful to be able to identify any potential problems early on and fix them before they become a bigger issue.

### Track and trace capabilities

When it comes to finding the right electronic batch record system for the business, track and trace capabilities should be near the top of the list. Being able to quickly and easily track product batches is essential for quality control and safeguarding against any potential product recalls.

This also means tracking where each batch came from, who made it, what ingredients were used, and how it was processed. This information is essential for ensuring compliance with all relevant safety regulations.

### Top tips

When looking for a quality electronic batch record system, there are a few key factors to keep in mind. Here are five of the most important:

1. **Usability**: The system should be easy to use and navigate, so batch data can quickly and easily tracked.
2. **Flexibility**: The system should be able to grow with the business, easily integrating new features and accommodating changes.
3. **Accuracy**: The system should be extremely accurate, ensuring that all data is properly logged and tracked.
4. **Security**: The system must be secure, protecting data from unauthorised access or alteration.
5. **Compatibility**: The system should be compatible with existing software and hardware.

Read about Opvia’s EBR software [here](https://www.opvia.io/) and sign up for a demo [here](https://www.opvia.io/contact).


What to look for in an electronic batch record system?

The global contract development manufacturing organisation (CDMO) industry is growing rapidly. As demand rises for generic medicines alongside an increased need for intricate and expensive production processes, more and more R&D companies are looking to outsource their drug development, and manufacturing.


The global contract development manufacturing organisation (CDMO) industry is growing rapidly. As demand rises for generic medicines alongside an increased need for intricate and expensive production processes, more and more R&D companies are looking to outsource their drug development, and manufacturing.

![](media/screen-shot-2022-08-19-at-5.45.04-pm.png)

With the growing demand, fostering communication and collaboration between CDMOs and R&D customers is increasingly important.

### Here are some best practices to ensure this is achieved. 

1. **Visibility of Process:** The supply chain in this industry is increasingly complex due to the number of people and stages involved. There is a need for greater visibility throughout a product’s life cycle. An EBR is essential here as customer audits and viewing controls features make it possible for customers to have visibility and influence over the manufacturing process.

![](media/screen-shot-2022-08-19-at-5.45.17-pm.png)

2. **Quantitative Results:** In order to evaluate the product on its quality and performance, measurable results from the manufacturing process are necessary. Efficient data analysis on an EBR can be used to evaluate the process performance.
3. **Consolidation of Data:** The quantitative metrics from the data analysis should be consolidated into reports that can be sent to customers to ensure they are satisfied with the process and the product. It is also important to use these metrics to validate the manufacturing process and technologies being used to ensure high quality and productivity within the CDMO.
4. **Review Process:** The R&D customer must review the batch records upon completion and this can be a time consuming process if they need to review an entire manual record. In contrast, with an EBR, an additional feature is the addition of completion certificates signed by authorised people which makes the review process much more efficient.

CDMOs are customer focused organisations and the implementation of an EBR helps in ensuring that there is smooth communication with the two stakeholders along with a high quality, and safe end product. The industry is highly fragmented with many players occupying market share, so following these best practices will also provide a competitive edge.

![](media/screen-shot-2022-08-19-at-5.47.23-pm.png)

Opvia’s no-code software solution is ideal for CMO/CDMOs to keep track of their manufacturing process. The simple platform also allows for greater collaboration with external sites, and stakeholders which is vital for research and process management. Read more about it .


Best Practices for a perfect EBR for CDMOs

When it comes to manufacturing and quality control in various industries, two essential types of documentation play critical roles: the Electronic Batch Record (EBR) and the Medical Device History Record (MDHR).


### Electronic Batch Record (EBR) vs. Medical Device History Record (MDHR)

When it comes to manufacturing and quality control in various industries, two essential types of documentation play critical roles: the Electronic Batch Record (EBR) and the Medical Device History Record (MDHR). These records serve distinct purposes and are particularly vital in ensuring the consistency, quality, and regulatory compliance of the products being manufactured. Below, we'll delve into the key differences and functions of these two types of records.

#### Electronic Batch Record (EBR)

An **Electronic Batch Record (EBR)** is a digital documentation system widely employed across multiple industries, including pharmaceuticals and general manufacturing. EBRs are designed to streamline and enhance the record-keeping process during the production of batches of products. Here are some key points to consider about EBRs:

- **Broad Applicability**: EBRs are not confined to a single industry but are versatile tools used in various sectors to maintain records.

- **Data Capture**: EBRs are instrumental in capturing and recording data related to the production process. This includes information about the materials used, production procedures, quality control checks, and other pertinent details.

- **Error Reduction**: By replacing or complementing manual record-keeping, EBRs significantly reduce the potential for errors in data entry and documentation. This, in turn, enhances the overall quality and consistency of the products being manufactured.

#### Medical Device History Record (MDHR)

On the other hand, the **Medical Device History Record (MDHR)** is a specialized document that is primarily relevant to the medical device manufacturing industry. It plays a unique and crucial role in this field and is a requirement set forth by regulatory bodies like the U.S. Food and Drug Administration (FDA). Here's a more comprehensive look at MDHR:

- **Industry Specific**: Unlike EBRs, MDHRs are specific to the medical device manufacturing industry. They are indispensable for ensuring regulatory compliance in the production of medical devices.

- **Regulatory Requirement**: MDHR is a regulated document, and its meticulous maintenance is mandated by regulatory authorities, especially in the United States. Compliance with these regulations is of paramount importance for medical device manufacturers.

- **Comprehensive Documentation**: MDHRs offer a comprehensive history of a medical device. This includes records detailing the device's design, manufacturing processes, and rigorous quality control measures applied throughout its production.

- **Lifecycle Tracking**: Perhaps the most distinctive aspect of MDHRs is their ability to track the entire lifecycle of a medical device. From initial design to any modifications made during production, every step is documented, ensuring transparency and traceability.

In conclusion, while both EBRs and MDHRs involve the critical function of record-keeping within the realm of manufacturing, the key distinction lies in their scope and industry-specific applicability. EBRs are versatile tools used in various sectors to streamline data capture and enhance quality, while MDHRs are specialized records mandated for the production of medical devices, ensuring rigorous regulatory compliance and meticulous traceability throughout the device's lifecycle.


What's the difference between an electronic batch record and a medical device history record?

Opvia Platform's CAPA management module provides a robust solution for tracking, investigating, and resolving quality issues. With automated workflows, root cause analysis, real-time collaboration, and data-driven decision-making, organizations can effectively address quality concerns, implement corrective actions, and drive continuous improvement.


Opvia Platform's CAPA management module provides a robust solution for tracking, investigating, and resolving quality issues. With automated workflows, root cause analysis, real-time collaboration, and data-driven decision-making, organizations can effectively address quality concerns, implement corrective actions, and drive continuous improvement. The platform ensures adherence to CAPA processes, promotes accountability, and supports regulatory compliance. Opvia Platform empowers organizations to proactively manage quality, enhance customer satisfaction, and drive overall business excellence.

- **Efficient CAPA Tracking:** Opvia Platform offers a dedicated module for managing Corrective and Preventive Actions (CAPAs), enabling organizations to efficiently track and document quality issues, deviations, and improvement opportunities.
- **End-to-End CAPA Lifecycle Management:** The platform supports the entire CAPA lifecycle, from initiation and investigation to root cause analysis, action planning, implementation, and verification, ensuring systematic and thorough quality improvement processes.
- **Automated Workflow and Task Management:** Opvia Platform automates the CAPA workflow, assigning tasks, sending notifications, and facilitating timely completion of CAPA activities, streamlining the entire process.
- **Root Cause Analysis and Corrective Actions:** The platform provides robust root cause analysis capabilities, allowing organizations to identify the underlying causes of quality issues and implement effective corrective actions to prevent recurrence.
- **Data-driven Decision Making:** The platform offers comprehensive analytics and reporting capabilities, enabling organizations to analyze CAPA data, identify trends, and make data-driven decisions for continuous quality improvement.



Integrated CAPA Management for Effective Quality Improvement

Corrective and Preventative Actions (CAPA)

Learn how Opvia helps companies streamline and standardise their BOM operations.  The Bill of Materials (BOM) is a crucial component of a batch record, particularly in pharmaceutical manufacturing.

Learn how Opvia helps companies streamline and standardise their BOM operations. 

The Bill of Materials (BOM) is a crucial component of a batch record, particularly in pharmaceutical manufacturing. It provides a comprehensive list of all the materials required to produce a specific batch of product. The BOM serves as a blueprint, guiding the production process and ensuring consistency, accuracy and quality throughout the manufacturing process.

BOMs are of utmost importance for GMP, especially for: 

* Accurate Inventory Management
* QC & Traceability
* Consistency and Standardisation
* Cost Control
* Regulatory Compliance
* Continuous Improvement & Process Optimization

By meticulously maintaining the BOM, manufacturing companies can uphold quality standards, meet regulatory requirements, optimise operations and deliver superior products with confidence. 

Harness the power of Opvia to revolutionise your BOM management and unlock a new level of efficiency and precision in your manufacturing operations.

<div style="position: relative; padding-bottom: calc(51.31707317073171% + 41px); height: 0; width: 100%"><iframe src="https://demo.arcade.software/6b1ZpGFHYhacvIuqoxy6?embed" frameborder="0" loading="lazy" webkitallowfullscreen mozallowfullscreen allowfullscreen style="position: absolute; top: 0; left: 0; width: 100%; height: 100%;color-scheme: light;" title="Bill of Materials"></iframe></div>

Nonconformance

The Opvia platform offers powerful data analytics capabilities tailored for the development of regulated products. It enables organizations to leverage data-driven insights, streamline decision-making, and enhance the development process while ensuring compliance with regulatory requirements.


The Opvia platform offers powerful data analytics capabilities tailored for the development of regulated products. It enables organizations to leverage data-driven insights, streamline decision-making, and enhance the development process while ensuring compliance with regulatory requirements.


- **Data Integration and Centralization:** Integrate data from various sources into a centralized platform, enabling comprehensive analysis and a holistic view of the product development process.
- **Advanced Analytics Tools:** Leverage advanced analytics tools, such as statistical analysis, predictive modeling, and machine learning algorithms, to uncover patterns, trends, and correlations within the data.
- **Real-time Monitoring and Alerting:** Monitor key performance indicators (KPIs) in real-time, enabling proactive identification of deviations, potential risks, and quality issues.
- **Risk-based Decision Making:** Analyze data to identify and mitigate risks, supporting risk-based decision-making throughout the product development lifecycle.
- **Regulatory Compliance:** Ensure adherence to regulatory requirements by leveraging data analytics to demonstrate product safety, efficacy, and quality during regulatory submissions.
- **Quality Control and Process Optimization:** Analyze data to identify opportunities for process optimization, quality improvement, and cost reduction while maintaining compliance with regulatory standards.
- **Product Performance Analysis:** Evaluate product performance and safety by analyzing data from clinical trials, adverse events, customer feedback, and post-market surveillance.
- **Data Visualization and Reporting:** Utilize data visualization techniques to present insights in a clear and concise manner, facilitating communication, understanding, and decision-making among stakeholders.
- **Continuous Improvement and Innovation:** Leverage data analytics to identify areas for continuous improvement, drive innovation, and enhance the overall product development process.

The Opvia platform's data analytics capabilities empower organizations to extract actionable insights from regulated product development data, facilitating informed decision-making, compliance with regulations, and continuous improvement in the pursuit of high-quality, safe, and effective products.

Ignite your scientific discoveries with our cutting-edge data analytics tool, designed to unravel the hidden patterns and insights within your research data. Leverage advanced algorithms, predictive models, and interactive visualisations to unlock the full potential of your datasets, leading to groundbreaking breakthroughs and advancing your field.

Analytics

The Opvia Platform serves as a powerful solution for efficient and effective audit management. With streamlined planning, centralized documentation, and automated workflows, organizations can optimize their audit processes and ensure compliance with regulatory requirements.


The Opvia Platform serves as a powerful solution for efficient and effective audit management. With streamlined planning, centralized documentation, and automated workflows, organizations can optimize their audit processes and ensure compliance with regulatory requirements. Real-time tracking and reporting capabilities enhance transparency and enable proactive decision-making. Opvia Platform empowers organizations to conduct successful audits, drive continuous improvement, and maintain the highest standards of quality and compliance.

- **Streamlined Audit Planning and Scheduling:** Opvia Platform provides a comprehensive audit management module to streamline the planning and scheduling of audits across your organization.
- **Centralized Audit Documentation:** The platform offers a centralized repository to store and manage audit-related documentation, ensuring easy access, version control, and collaboration among audit teams.
- **Compliance and Corrective Actions:** Opvia Platform supports compliance with regulatory standards by capturing audit findings and facilitating the management of corrective and preventive actions (CAPAs).
- **Comprehensive Reporting and Analytics:** Leveraging data analytics and reporting capabilities, Opvia Platform enables the generation of comprehensive audit reports, providing insights, trends, and areas for improvement.



Opvia Platform: Empowering Seamless Audit Management

Audit Management

Learn how Opvia helps companies streamline and standardise their BOM operations. 

The Bill of Materials (BOM) is a crucial component of a batch record, particularly in pharmaceutical manufacturing. It provides a comprehensive list of all the materials required to produce a specific batch of product. The BOM serves as a blueprint, guiding the production process and ensuring consistency, accuracy and quality throughout the manufacturing process.

BOMs are of utmost importance for GMP, especially for: 

* Accurate Inventory Management
* QC & Traceability
* Consistency and Standardisation
* Cost Control
* Regulatory Compliance
* Continuous Improvement & Process Optimization

By meticulously maintaining the BOM, manufacturing companies can uphold quality standards, meet regulatory requirements, optimise operations and deliver superior products with confidence. 

Harness the power of Opvia to revolutionise your BOM management and unlock a new level of efficiency and precision in your manufacturing operations.



Bill of Materials

**Development Change Control Module** The Development Change Control Module is a crucial component of our Quality Management System, designed to streamline change management within the development process.

**Development Change Control Module**

The Development Change Control Module is a crucial component of our Quality Management System, designed to streamline change management within the development process. It offers a centralized platform for tracking, prioritizing, and documenting changes, ensuring smooth implementation and superior product outcomes.


- **Efficient Change Management:** Seamlessly manage change requests throughout the development lifecycle, from initiation to implementation.
- **Enhanced Collaboration:** Foster collaboration among development teams, facilitating communication, document sharing, and real-time updates.
- **Informed Decision-Making:** Conduct comprehensive impact assessment and risk analysis, enabling data-driven decisions and minimizing disruptions.
- **Improved Quality Control:** Ensure adherence to quality standards by effectively tracking, prioritizing, and documenting changes, leading to enhanced product quality.
- **Regulatory Compliance:** Maintain compliance by documenting changes, establishing audit trails, and generating necessary reports.
- **Increased Efficiency:** Automate workflows, notifications, and approvals to reduce manual efforts and accelerate the change control process.
- **Faster Time-to-Market:** Minimize delays and bottlenecks, optimizing development timelines for faster product releases.
- **Continuous Improvement:** Leverage change data and analytics for insights to drive continuous improvement efforts, enhancing development processes and customer satisfaction.


Streamline Change Management and Elevate Development Decisions with the Change Control Module

Change Control

Opvia Platform has change control built-in as first-class functionality. The platform ensures comprehensive change documentation, facilitating compliance and providing organizations with a structured approach to manage and implement changes while maintaining product quality and regulatory compliance.


Opvia Platform has change control built-in as first-class functionality. The platform ensures comprehensive change documentation, facilitating compliance and providing organizations with a structured approach to manage and implement changes while maintaining product quality and regulatory compliance.

- **Efficient Change Request Management:** Opvia Platform provides a robust change control module that enables efficient management of change requests throughout the organization.
- **Centralized Change Control Repository:** The platform offers a centralized repository for documenting and tracking all change requests, ensuring visibility and traceability across departments and teams.
- **Versioning and Documentation:** The platform maintains version control and documentation for all change requests, allowing stakeholders to access historical records, track changes, and ensure compliance with regulatory requirements.
- **Real-time Notifications and Collaboration:** The platform sends real-time notifications and enables collaborative discussions among stakeholders involved in the change control process, ensuring effective communication and timely resolution of issues.



Streamlined Change Control Management

Opvia Platform offers companies in the regulated products industry a powerful data portal to effortlessly share information with their clients. With Opvia's integrated capabilities and collaborative environment, companies can establish a secure and efficient data sharing process, enhancing client collaboration and transparency.


Opvia Platform offers companies in the regulated products industry a powerful data portal to effortlessly share information with their clients. With Opvia's integrated capabilities and collaborative environment, companies can establish a secure and efficient data sharing process, enhancing client collaboration and transparency.

- **Centralized Data Management:** Opvia serves as a centralized hub for all relevant data, including quality data, compliance records, and manufacturing information. This ensures that clients have access to accurate and up-to-date information, as everything is connected and integrated within the platform.

- **Secure and Controlled Data Access:** Opvia provides a secure data portal where companies can control data access and permissions for each client. This ensures that only authorized individuals can access specific data sets, safeguarding sensitive information and maintaining data privacy.

- **Customizable Data Views:** Opvia offers customizable data views and dashboards, empowering companies to tailor the data presentation to meet their clients' needs. Clients can easily navigate and analyze the data that is most relevant to them, gaining valuable insights and facilitating effective decision-making.


Opvia Data Portal: Empowering Seamless Data Sharing with Clients

Client Data Portal

Opvia Platform empowers companies producing regulated products to effectively manage client relationships, ensuring efficient communication, streamlined project management, and enhanced client satisfaction.


Opvia Platform empowers companies producing regulated products to effectively manage client relationships, ensuring efficient communication, streamlined project management, and enhanced client satisfaction. With centralized client information, integrated workflows, real-time communication, and project tracking capabilities, Opvia enables companies to deliver high-quality products and services, meet client expectations, and drive business success.

- **Efficient Client Management:** Opvia Platform offers a comprehensive solution for companies producing regulated products to effectively manage client relationships. With the ability for every team to edit and execute procedures directly within the platform, client management becomes streamlined, ensuring efficient communication, collaboration, and customer satisfaction.
- **Centralized Client Data and Information:** Opvia provides a centralized repository for managing all aspects of client interactions, including client details, communications, contracts, and project documentation. The platform allows for seamless access and sharing of client information across teams, ensuring a consistent and coordinated approach in managing client relationships.
- **Track and Manage Client Projects:** Opvia allows companies to track and manage client projects, including milestones, deliverables, and timelines. The platform provides visibility into project progress, enabling proactive management and ensuring timely delivery of high-quality products to clients.
- **Report automation:** Opvia Platform provides robust reporting capabilities, allowing companies to generate comprehensive and professional reports for their clients. With Opvia's intuitive interface and powerful analytics features, generating insightful reports becomes a seamless and efficient process.
  


Seamlessly Manage Client Data, Reporting and Relationships

Client Management

Opvia Platform offers companies in the regulated products industry a robust solution for efficiently tracking and managing client complaints. With Opvia's integrated capabilities and collaborative environment, companies can streamline the complaint handling process, ensure timely resolution, and enhance client satisfaction.


Opvia Platform offers companies in the regulated products industry a robust solution for efficiently tracking and managing client complaints. With Opvia's integrated capabilities and collaborative environment, companies can streamline the complaint handling process, ensure timely resolution, and enhance client satisfaction.

- **Centralized Complaint Management:** Opvia serves as a centralized platform for managing client complaints. All complaint-related information, including details, status updates, and communication logs, are stored in one place, making it easy for teams to track and address each complaint effectively.

- **Efficient Workflow Automation:** Opvia automates the complaint handling workflow, ensuring that each complaint is appropriately assigned, tracked, and escalated if necessary. With customizable workflows and automated notifications, teams can streamline the entire process and ensure timely resolution.

- **Real-time Collaboration:** Opvia facilitates real-time collaboration among teams and stakeholders involved in complaint resolution. Users can communicate, share information, and collaborate on resolving issues directly within the platform, promoting efficient and transparent communication.

- **Comprehensive Data Analysis:** Opvia provides comprehensive data analysis capabilities to identify patterns, trends, and root causes of client complaints. With advanced analytics and reporting tools, companies can gain valuable insights, enabling them to implement proactive measures and continuously improve their products and services.

- **Regulatory Compliance:** Opvia ensures compliance with regulatory requirements related to complaint management. The platform supports documentation, traceability, and audit trails, making it easier for companies to demonstrate compliance during regulatory inspections or audits.

Opvia Complaint Tracking: Streamlining Client Complaint Management

Complaint Tracking

The Opvia platform offers a dedicated CRO Data Portal, enabling life science companies to provide secure access to contract research organizations (CROs) for direct data submission.


The Opvia platform offers a dedicated CRO Data Portal, enabling life science companies to provide secure access to contract research organizations (CROs) for direct data submission. This streamlined process enhances collaboration, data integrity, and efficiency in research and development.

Benefits:

- **Efficient Data Submission:** Enable direct data submission from CROs through a secure and user-friendly portal, eliminating manual data transfers and streamlining the submission process.
- **Seamless Collaboration:** Foster real-time collaboration between life science companies and CROs, allowing smooth exchange of data, updates, and insights.
- **Data Security and Confidentiality:** Ensure the security and confidentiality of sensitive data through robust encryption, access controls, and data protection measures.
- **Enhanced Data Integrity:** Minimize errors and discrepancies by facilitating standardized data submission formats, improving data accuracy and reliability.
- **Real-time Tracking and Monitoring:** Monitor the progress of data submissions in real time, providing visibility into the status and ensuring timely processing and review.
- **Streamlined Workflows:** Automate workflows and reduce administrative overhead, allowing life science companies and CROs to focus on research and analysis.
- **Regulatory Compliance:** Maintain compliance with regulatory requirements by capturing necessary documentation and audit trails for data submission.
- **Improved Efficiency and Time-to-Market:** Accelerate research and development timelines by expediting data submission, analysis, and decision-making processes.

The Opvia CRO Data Portal empowers life science companies to seamlessly collaborate with CROs, facilitating direct data submission in a secure and efficient manner. It optimizes data management, enhances collaboration, and supports timely research and development in the life science industry.

Unlock a world of possibilities with our groundbreaking CRO data portal solution. Seamlessly integrate and centralize your CRO data, empowering you to collaborate effortlessly, gain real-time insights, and accelerate your discovery and development.

CRO Data Portal

Deviations and out-of-specifications (OOS) are situations that may occur in any manufacturing processes and in quality control experiments, either due to internal or external factors.  Often, these parameters are identified too late, creating a knock-on effect which affects subsequent processes and/or experiments, and ultimately, delays to projects.

Deviations and out-of-specifications (OOS) are situations that may occur in any manufacturing processes and in quality control experiments, either due to internal or external factors. 

Often, these parameters are identified too late, creating a knock-on effect which affects subsequent processes and/or experiments, and ultimately, delays to projects.

Opvia provides a real-time dashboard that allows you to monitor and track key numeric indicators or parameters related to manufacturing and laboratory operations. By setting up alerts and notifications, you can quickly identify deviations or OOS situations and take corrective action before they become bigger problems.

Opvia enables quick identification of deviations or OOS by providing real-time monitoring, alerts and notifications, data analytics, and reporting capabilities. You can easily visualize data related to throughput, wait times, and other important metrics. 

The platform includes built-in data analytics capabilities, allowing you to drill down into the data to identify specific trends or patterns. By analyzing this data, you can identify areas for improvement and develop strategies to optimize your operations.

Deviations and/or Out-of-specifications (OOS)	

Opvia Platform's deviations management module provides a comprehensive solution for tracking, investigating, and resolving deviations within an organization. With centralized deviation records, automated workflows, and robust root cause analysis capabilities, organizations can effectively address deviations and implement appropriate corrective actions.


Opvia Platform's deviations management module provides a comprehensive solution for tracking, investigating, and resolving deviations within an organization. With centralized deviation records, automated workflows, and robust root cause analysis capabilities, organizations can effectively address deviations and implement appropriate corrective actions. Real-time visibility and reporting features enable data-driven decision-making, while the platform's compliance support ensures adherence to regulatory requirements. Opvia Platform empowers organizations to enhance their quality assurance practices, minimize deviations, and improve overall operational efficiency.

- **Efficient Deviation Tracking:** Opvia Platform offers a dedicated module for deviations management, enabling organizations to efficiently track and manage all types of deviations from established procedures or specifications.
- **Centralized Deviation Repository:** The platform provides a centralized repository for documenting and storing all deviation records, ensuring easy access, traceability, and collaboration across teams.
- **Root Cause Analysis and Corrective Actions:** The platform facilitates root cause analysis of deviations, empowering organizations to identify underlying issues and implement corrective and preventive actions (CAPAs) to prevent recurrence.
- **Real-time Visibility and Reporting:** Opvia Platform offers real-time visibility into the status and progress of deviations, allowing stakeholders to monitor and analyze trends, track resolution timelines, and generate comprehensive reports.



Opvia Platform: Streamlining Deviations Management for Quality Assurance*

Deviations Management

An electronic device history record (eDHR) allows device companies to centrally collect and maintain all of the records required by the FDA’s Quality System Regulation (21 CFR Part 820) to document the production of each batch, unit or lot of a finished device.


An electronic device history record (eDHR) allows device companies to centrally collect and maintain all of the records required by the FDA’s Quality System Regulation (21 CFR Part 820) to document the production of each batch, unit or lot of a finished device. The Opvia platform offers robust capabilities for managing Device History Records (DHR), providing organizations with a comprehensive solution to document and track the manufacturing history of medical devices. Built to exact needs and integrated within the same platform, Opvia seamlessly integrates with Quality Management Systems (QMS), quality data management, and batch record capabilities, ensuring efficient and compliant manufacturing processes. 

- **Complete Documentation:** Dates of manufacture. Quantity manufactured. Quantity released for distribution. Acceptance records which demonstrate the device is manufactured in accordance with the DMR. Primary identification label and labeling used for each production unit. Unique device identifiers (UDI) or other control numbers for each batch, lot or unit that a device company produces. Return material authorization (RMA), returns and repairs. Complaints and DMR change management.
- **Seamless Integration with QMS:** Integrate DHR capabilities with QMS to enforce quality control procedures, manage non-conformances, track corrective actions, and ensure compliance with regulatory standards.
- **Electronic Signatures and Audit Trails:** Capture electronic signatures for authentication and authorization, providing a secure and legally compliant audit trail for device manufacturing activities.
- **Regulatory Compliance:** Streamline regulatory compliance by easily accessing and presenting comprehensive device manufacturing documentation during audits and inspections.


Opvia for Device History Records: Comprehensive Documentation and Integration

Device History Records

Opvia Platform's document control capabilities empower organizations to effectively manage their documents throughout their lifecycle. With a centralized repository, automated workflows, version control, and document change notifications, teams can collaborate efficiently, ensure compliance, and reduce the risk of using outdated or incorrect documents.

Opvia Platform's document control capabilities empower organizations to effectively manage their documents throughout their lifecycle. With a centralized repository, automated workflows, version control, and document change notifications, teams can collaborate efficiently, ensure compliance, and reduce the risk of using outdated or incorrect documents. The platform's search and retrieval capabilities further enhance productivity and enable easy access to critical information. Opvia Platform provides a comprehensive solution for document control, supporting organizations in their pursuit of efficient and effective quality management.

- **Centralized Document Repository:** Opvia Platform provides a centralized repository to store, manage, and control all types of documents, ensuring easy access, version control, and collaboration across teams and departments.
- **Document Lifecycle Management:** The platform supports the entire document lifecycle, from creation and revision to approval, distribution, and obsolescence, enabling organizations to maintain control and compliance.
- **Version Control and Document History:** Opvia Platform tracks document versions, maintains revision history, and allows users to access previous versions, ensuring traceability and facilitating regulatory compliance.
- **Automated Review and Approval Processes:** The platform automates document review and approval workflows, streamlining the review cycles, reducing manual efforts, and ensuring timely approval and distribution.
- **Document Change Notifications:** Opvia Platform sends real-time notifications to relevant stakeholders when documents are revised or updated, ensuring awareness and facilitating seamless transitions.
- **Search and Retrieval Capabilities:** The platform offers robust search and retrieval functionalities, enabling users to quickly find and retrieve specific documents based on keywords, metadata, or document attributes.



Speed up the feedback loop from SOP revisions to employee training. 

Document Control

The Opvia platform serves as a comprehensive Electronic Batch Record (EBR) system, offering organizations the ability to digitize and automate their batch record management processes.


The Opvia platform serves as a comprehensive Electronic Batch Record (EBR) system, offering organizations the ability to digitize and automate their batch record management processes. It provides a centralized and integrated solution for capturing, managing, and tracking batch-related data throughout the manufacturing lifecycle.

- **Digitized and Paperless Workflow:** Replace paper-based batch records with digital records, reducing manual documentation efforts and eliminating the risk of errors associated with manual data entry.
- **Real-time Data Capture:** Capture batch data in real-time during the manufacturing process, ensuring accurate and up-to-date information for each batch.
- **Standardized Templates and Forms:** Utilize standardized templates and forms for consistent data entry, facilitating data analysis, comparison, and reporting across different batches.
- **Complete Batch Traceability:** Achieve end-to-end traceability of batch records, tracking the entire manufacturing process from raw materials to finished products, including equipment, personnel, and quality control activities.
- **Automated Workflows and Approvals:** Implement automated workflows for review, approval, and sign-off processes, ensuring timely execution and compliance with regulatory requirements.
- **Version Control and Revision History:** Maintain a version-controlled system with a detailed revision history, enabling easy tracking of changes made to batch records over time.
- **Electronic Signatures and Audit Trails:** Capture electronic signatures for authentication and authorization, providing a secure and legally compliant audit trail for batch records.
- **Real-time Process Monitoring:** Monitor critical process parameters and deviations in real-time, allowing proactive identification and resolution of issues during manufacturing.
- **Efficient Data Analysis and Reporting:** Analyze batch data to identify trends, patterns, and process optimizations, enabling data-driven decision-making and continuous improvement initiatives.
- **Integration with Quality Management Systems:** Seamlessly integrate with Quality Management Systems (QMS), allowing for comprehensive quality control and compliance management throughout the manufacturing process.

The Opvia platform as an Electronic Batch Record (EBR) system streamlines manufacturing operations by digitizing and automating batch record management processes. It improves data accuracy, enhances batch traceability, ensures compliance, and facilitates efficient analysis and reporting for optimized manufacturing processes.

Liberate your production process from the limits of paper with Opvia's intelligent EBR system. Design, deploy and execute any batch process, all in a single platform. 

Electronic Batch Records (EBR)

The Opvia platform offers a powerful Electronic Lab Notebook (ELN) feature that transforms traditional paper-based lab notebooks into a digital solution. It provides scientists and researchers with a centralized platform to record, organize, and collaborate on experimental data, streamlining workflows and enhancing productivity.


The Opvia platform offers a powerful Electronic Lab Notebook (ELN) feature that transforms traditional paper-based lab notebooks into a digital solution. It provides scientists and researchers with a centralized platform to record, organize, and collaborate on experimental data, streamlining workflows and enhancing productivity.

### Benefits:

- **Efficient Data Management**: Digitally capture and organize experimental data, eliminating the need for manual paper-based records and enabling efficient data management.
- **Collaborative Research**: Facilitate seamless collaboration among team members by allowing easy sharing, commenting, and collaboration on experimental data and findings.
- **Data Accessibility**: Store and access experimental data from anywhere at any time, ensuring data availability and reducing dependency on physical lab notebooks.
- **Data Security and Integrity**: Maintain data security and integrity through controlled access, user permissions, and data backup, ensuring the safety of valuable research data.
- **Improved Search and Retrieval**: Easily search, filter, and retrieve specific experiments or data points using advanced search functionalities, saving time and enhancing data accessibility.
- **Version Control and Audit Trail**: Track changes and maintain a complete audit trail of experiment versions, revisions, and annotations, ensuring data traceability and compliance.
- **Integration with Instruments and Systems**: Seamlessly integrate with laboratory instruments and systems to directly capture data, reducing manual errors and enhancing data accuracy.
- **Advanced Data Analysis**: Integrate with data analysis tools and perform advanced analytics on experimental data, unlocking valuable insights for research and decision-making.

The Opvia Electronic Lab Notebook empowers scientists and researchers with a digital platform to efficiently manage data, collaborate seamlessly, and accelerate scientific discoveries.

Unlock the full potential of your research with our modern ELN, packed with advanced features designed to simplify and accelerate your development journey. From customisable and compliant templates to automated data processing and analytical tools, our platform empowers you to focus on the science.

Electronic Lab Notebook (ELN)

Environmental experiments (such as bioburden) and water testing are essential tests that must be carried out in any GxP contract manufacturing or research organisation.

Environmental experiments (such as bioburden) and water testing are essential tests that must be carried out in any GxP contract manufacturing or research organisation. These tests ensure the cleanliness of the facility, to ensure the highest quality standards for manufacturing processes.

These analyses are daily, repetitive, and amount to a large quantity of data. It also can be tedious exporting these data onto a easy-to-understand format for batch record reviews. 

Opvia offers a simple solution for tracking daily environmental and water analyses results. With Opvia, you can easily input and organise data, as well as generate reports and visualisations. By streamlining the data collection and analysis process, Opvia can help you make more informed decisions and improve the overall efficiency of other operations within the plant.

Opvia saves you time and effort by providing a platform to store all your data in one easily accessible place. This allows you to easily track and manage your results and identify common “dirty” areas that need more attention. 

Opvia is designed to be user-friendly and intuitive - so you don't need to be a data expert to use it. Its simplicity and efficiency makes it an excellent choice to be used as a platform for environmental and water analyses.

Environmental Testing 

The Opvia Platform is designed to streamline equipment calibration processes by offering centralized management, automated scheduling, and efficient documentation and traceability.


The Opvia Platform is designed to streamline equipment calibration processes by offering centralized management, automated scheduling, and efficient documentation and traceability. It ensures timely maintenance, compliance with regulations, and enhanced accuracy in equipment calibration for improved operational efficiency.

- **Centralized Calibration Management:** Opvia Platform provides a centralized system for managing equipment calibration processes, simplifying the overall calibration management workflow.
- **Automated Calibration Scheduling:** The platform enables automated scheduling of calibration tasks, ensuring timely maintenance and adherence to calibration schedules.
- **Efficient Documentation and Traceability:** Opvia Platform facilitates the documentation and traceability of calibration activities, maintaining comprehensive records for regulatory compliance and audit purposes.



Ensure unparalleled equipment performance and compliance with ease. Maintain accuracy at every stage of your manufacturing process to deliver quality products like never before. 

Equipment Calibration

Capturing and comparing bioreactor data plays a pivotal role in the success of biotechnology firms, as it offers them a wealth of valuable information to optimize their processes, ensure stringent quality control, and drive continuous innovation.

Capturing and comparing bioreactor data plays a pivotal role in the success of biotechnology firms, as it offers them a wealth of valuable information to optimize their processes, ensure stringent quality control, and drive continuous innovation. The ability to monitor and analyze critical parameters such as temperature, pH, dissolved oxygen levels, nutrient concentrations, and cell growth in real-time provides deep insights into the performance of bioreactors and the overall bioprocess.

By capturing bioreactor data, companies gain a comprehensive understanding of the dynamic conditions within the system, enabling them to detect subtle changes, identify trends, and make informed decisions promptly. This data-driven approach facilitates the identification of optimal process parameters, leading to enhanced productivity, improved product quality, and reduced production costs.

However, managing and analyzing large volumes of bioreactor data can be a daunting task. That's where our powerful software comes into play. The Opvia Platform simplifies the data capture process, enabling biotechnology firms to effortlessly collect and store data from multiple bioreactors in a centralized database. With intuitive data visualization and analysis tools, The Opvia Platform empowers researchers and engineers to efficiently explore and compare data sets, uncover patterns, and gain actionable insights.

The software's advanced analytical capabilities allow for run-to-run comparisons, statistical analysis, and trend identification, which are essential for process optimization and troubleshooting. It enables biotechnologists to pinpoint process inefficiencies, identify bottlenecks, and optimize critical parameters to maximize yield and productivity. Moreover, the software facilitates rapid detection of anomalies or deviations, triggering timely corrective actions to maintain process integrity and product quality.

Bioreactor Data Capture

The Opvia platform integrates robust data management capabilities that align with the FAIR (Findable, Accessible, Interoperable, Reusable) data principles. It ensures effective data management, sharing, and utilization, enabling data-driven decision-making and promoting collaboration.


The Opvia platform integrates robust data management capabilities that align with the FAIR (Findable, Accessible, Interoperable, Reusable) data principles. It ensures effective data management, sharing, and utilization, enabling data-driven decision-making and promoting collaboration.

What is FAIR data management?

- **Findability:** Enhance data discoverability through comprehensive metadata, standardized descriptions, and advanced search functionalities.
- **Accessibility:** Ensure authorized access to data with controlled permissions, authentication protocols, and secure sharing mechanisms.
- **Interoperability:** Enable seamless integration with various data sources, systems, and platforms, facilitating efficient data exchange and utilization.
- **Reusability:** Promote data reuse by providing well-documented and structured data, reducing redundancy, and encouraging collaboration.

How is it made possible on the Opvia platform:

- **Data Integrity:** Maintain data quality and integrity through governance practices, validation rules, and error prevention mechanisms.
- **Data Preservation:** Safeguard data for long-term usability and future research with archival, backup, and version control capabilities.
- **Compliance and Auditability:** Support regulatory compliance with proper documentation, audit trails, and data provenance.
- **Collaboration:** Facilitate collaboration by providing a centralized platform for data sharing, communication, and collaboration among stakeholders.

The Opvia platform's data management capabilities align with the FAIR data principles, empowering organizations to efficiently manage and leverage their data assets for informed decision-making, innovation, and collaborative research.

Keep up with the increasing volume, complexity and speed of data creation and be FAIR Compliant. Keep your data findable, accessible, interoperable and reusable. 

FAIR Data Management

The Opvia platform offers robust capabilities to function as a comprehensive Laboratory Information Management System (LIMS). It serves as a centralized solution for laboratory data management, sample tracking, and workflow optimization, enabling efficient laboratory operations and enhancing data integrity.


The Opvia platform offers robust capabilities to function as a comprehensive Laboratory Information Management System (LIMS). It serves as a centralized solution for laboratory data management, sample tracking, and workflow optimization, enabling efficient laboratory operations and enhancing data integrity.


- **Centralized Data Management:** Store and manage laboratory data in a centralized repository, ensuring easy access, organization, and retrieval.
- **Sample Tracking and Management:** Track and manage sample lifecycle, from collection to analysis, with automated workflows, ensuring traceability and reducing errors.
- **Data Integrity and Quality Control:** Implement validation rules, standardized protocols, and data verification mechanisms to ensure data integrity and quality control.
- **Efficient Workflow Optimization:** Streamline laboratory processes, automate tasks, and optimize workflows to enhance operational efficiency and productivity.
- **Instrument Integration:** Seamlessly integrate with laboratory instruments and equipment to capture data directly, minimizing manual entry errors and enhancing efficiency.
- **Audit Trail and Compliance:** Maintain an audit trail of activities, changes, and data modifications to meet regulatory compliance requirements and facilitate audits.
- **Real-time Monitoring and Reporting:** Monitor laboratory activities, generate real-time reports, and gain insights into operational performance for data-driven decision-making.
- **Collaboration and Communication:** Foster collaboration among laboratory personnel, enabling data sharing, annotations, and communication within the platform.
- **Data Security and Access Control:** Ensure data security and confidentiality with role-based access control, user permissions, and data encryption mechanisms.

The Opvia platform's capabilities as a Laboratory Information Management System (LIMS) enable efficient laboratory operations, data management, and collaboration, supporting research, analysis, and quality control in various scientific domains.

Experience a seamless integration of data management, sample tracking and experimental workflows with the Opvia LIMS, designed to optimise efficiency and enhance scientific outcomes. Say goodbye to manual record-keeping and data inconsistencies and embrace a centralised platform that provides real-time data access, analysis and collaboration.

Lab Information Management System (LIMS)

Simplify accuracy and compliance with Opvia's Label Printing and Control module. Designed to align seamlessly with FDA's CFR Title 21 and GMP, ensure precise labeling and meet regulatory standards effortlessly.


Simplify accuracy and compliance with Opvia's Label Printing and Control module. Designed to align seamlessly with FDA's CFR Title 21 and GMP, ensure precise labeling and meet regulatory standards effortlessly. Enhance traceability, streamline approvals, and label confidently with data security and validation.

- **Data Accuracy and Integration**: Seamlessly integrates with relevant data sources to maintain accurate and up-to-date information on labels.

- **Version-Control, Audit Trail and Traceability**: Tracks all label-related activities, creating an audit trail with timestamps, user identifications, and data changes. This level of traceability supports CFR Title 21 and GMP requirements for tracking and accountability.

- **Validation and Verification**: Prior to printing, the module validates label data to confirm its adherence to CFR Title 21 specifications, reducing the risk of non-compliance.

Opvia Platform for Label Printing and Control: Compliant and Automated Label Printing

Label Printing and Control

Inventory management is an essential aspect of any laboratory. Without the necessary reagents, solutions, and lab materials, experiments cannot be properly conducted - thus it is paramount that inventory and supplies in the laboratory are tracked to ensure that there are always adequate materials for experiments and research.  Most laboratories still rely on paper-based methods to track and restock inventory - this can be slow, tedious, and inaccurate, especially if materials are kept in a warehouse.  Opvia is a powerful inventory management software that can be used to track laboratory inventory and supplies.

Inventory management is an essential aspect of any laboratory. Without the necessary reagents, solutions, and lab materials, experiments cannot be properly conducted - thus it is paramount that inventory and supplies in the laboratory are tracked to ensure that there are always adequate materials for experiments and research. 

Most laboratories still rely on paper-based methods to track and restock inventory - this can be slow, tedious, and inaccurate, especially if materials are kept in a warehouse. 

Opvia is a powerful inventory management software that can be used to track laboratory inventory and supplies. It offers a range of features such as real-time inventory tracking, automatic reordering, and customisable alerts. With Opvia, you can easily manage your inventory, track usage, and ensure that you always have the supplies you need. 

In addition, Opvia’s customisable platform enables you to link laboratory data with inventory - enabling you a one-click, fast access to track inventory within your labs - an excellent interface to streamline your inventory management processes, saving time and costs.

Laboratory Inventory Tracking

In contract manufacturing organisations, manufacturing is often 24/7, and process samples may be generated every couple of hours for quality control (QC) analysis.

In contract manufacturing organisations, manufacturing is often 24/7, and process samples may be generated every couple of hours for quality control (QC) analysis.

These samples often need to undergo real-time analysis to track progress and numerical parameters of the manufacturing process. 

Manufacturing and QC teams require this data to be readily shared and easily accessible by both departments.

Opvia provides a centralised platform to facilitate data exchange - where team members can access and share data related to the manufacturing process or QC laboratory experiments. Users can upload and manage documents, including blueprints, schematics, and production reports, and collaborate on them in real-time.

Opvia allows manufacturing and QC teams to collaborate seamlessly, enabling quick and easy data sharing - this helps ensure that any issues or defects are quickly identified and resolved, improving the overall quality of the final product. The platform helps streamline the manufacturing and quality control processes, enabling teams to work more efficiently and effectively.

Live Data Sharing between Teams

Customers of CDMOs often want real time updates of the on-going manufacturing process, and want to be notified of any major deviations or delays within the production process.

Customers of CDMOs often want real time updates of the on-going manufacturing process, and want to be notified of any major deviations or delays within the production process.

Often, data obtained from manufacturing or quality control processes need to be keyed into a sheet, analysed, summarised, and finally exported as a report to be sent to customers. This process is painfully slow and tedious - and takes unnecessary time and manpower of more important things that could be focused on during manufacturing.

Opvia enables customers to track and monitor manufacturing processes in real time by providing a cloud-based platform that integrates with existing systems to provide real-time data analytics and insights. This allows customers to quickly identify and resolve issues as they arise, reducing downtime and increasing production efficiency. 

With Opvia, customers can easily track key performance indicators such as cycle time, downtime, and product yield.

Opvia's platform is also designed to collect and analyze data from multiple sources, enabling customers to gain a comprehensive view of their manufacturing processes. Opvia's platform makes it easy for customers to visualize data through customizable dashboards and reports to monitor on-going production and laboratory processes.

Live Data Sharing to Customers

The Opvia Platform empowers manufacturing organizations with robust data analytics capabilities, enabling them to unlock valuable insights from their manufacturing data.


The Opvia Platform empowers manufacturing organizations with robust data analytics capabilities, enabling them to unlock valuable insights from their manufacturing data. By integrating, analyzing, and visualizing manufacturing data, stakeholders can make data-driven decisions, optimize processes, and drive continuous improvement for enhanced operational efficiency and productivity.

- **Data Integration and Consolidation:** Opvia Platform integrates and consolidates manufacturing data from various sources, providing a unified view for comprehensive data analysis.
- **Advanced Analytics and Visualization:** The platform offers advanced analytics tools and visualization capabilities to analyze manufacturing data, identify trends, patterns, and anomalies, and gain actionable insights for process optimization.
- **Real-time Monitoring and Decision-making:** Opvia Platform enables real-time monitoring of manufacturing operations, empowering stakeholders to make informed decisions promptly based on accurate and up-to-date data.
- **Predictive and Prescriptive Analytics:** Leveraging advanced analytics techniques, Opvia Platform supports predictive and prescriptive analytics, enabling organizations to anticipate issues, optimize processes, and improve overall manufacturing performance.
- **Continuous Improvement Initiatives:** By leveraging manufacturing data analytics, Opvia Platform supports continuous improvement initiatives, helping organizations identify areas for optimization, reduce waste, and increase productivity.


Opvia Platform for Manufacturing Data Analytics: Driving Insights and Optimization

Manufacturing Analytics

- **Real-time Data Acquisition:** Opvia platform automates the acquisition of manufacturing process data in real-time, ensuring timely and accurate information. - **Seamless Integration:** It seamlessly integrates data from diverse sources, such as equipment sensors, IoT devices, and production systems, providing a unified view of the manufacturing process.


- **Real-time Data Acquisition:** Opvia platform automates the acquisition of manufacturing process data in real-time, ensuring timely and accurate information.
- **Seamless Integration:** It seamlessly integrates data from diverse sources, such as equipment sensors, IoT devices, and production systems, providing a unified view of the manufacturing process.

The Opvia platform offers the capability to automatically acquire and integrate manufacturing process data, enabling organizations to gain valuable operational insights. By capturing data in real-time and seamlessly integrating it from various sources, Opvia ensures accurate information and provides a comprehensive understanding of the manufacturing process. This empowers organizations to make informed decisions, optimize operations, and drive continuous improvement for enhanced operational efficiency.

Opvia for Automated Acquisition and Integration of Manufacturing Process Data: Enhancing Operational Insight

Automated Manufacturing Data Acquisition

- **Data Capture and Storage:** Opvia platform serves as a data historian, capturing and securely storing operational data from various sources over time. - **Data Retention and Accessibility:** It provides long-term retention of historical data, ensuring easy access to past operational information for analysis and decision-making.


- **Data Capture and Storage:** Opvia platform serves as a data historian, capturing and securely storing operational data from various sources over time.
- **Data Retention and Accessibility:** It provides long-term retention of historical data, ensuring easy access to past operational information for analysis and decision-making.

Opvia platform offers the capability of a data historian, enabling organizations to capture and analyze operational data from diverse sources. With its data capture and storage functionality, Opvia securely retains historical data, allowing organizations to access and analyze past operational information for trend analysis, performance evaluation, and process optimization. This capability enhances data-driven decision-making and supports continuous improvement efforts for improved operational efficiency and productivity.

Opvia Data Historian: Capturing and Analyzing Operational Data

Data Historian

The Opvia platform offers comprehensive capabilities as a Manufacturing Execution System (MES), enabling organizations to streamline production processes while integrating seamlessly with Quality Management Systems (QMS), quality data management, and batch record (EBR) capabilities.


The Opvia platform offers comprehensive capabilities as a Manufacturing Execution System (MES), enabling organizations to streamline production processes while integrating seamlessly with Quality Management Systems (QMS), quality data management, and batch record (EBR) capabilities.

**Benefits:**

- **Quality Control Integration:** Seamlessly integrate with QMS to enforce quality control procedures, perform in-process inspections, manage non-conformances, and ensure compliance with regulatory requirements.
- **Data Collection and Analysis:** Collect real-time data from production processes, enabling comprehensive data analysis to identify trends, patterns, and areas for process optimization.
- **Batch Record Management:** Utilize integrated batch record capabilities to capture, manage, and track batch-related data, ensuring compliance, traceability, and accurate documentation of production activities.
- **Quality Data Management:** Integrate with quality data management systems to capture, analyze, and report quality-related data, enabling proactive quality control and continuous improvement initiatives.
- **Electronic Signature and Audit Trails:** Capture electronic signatures and maintain audit trails for production activities, providing a secure and legally compliant record of actions and approvals.
- **Performance Dashboards and Reporting:** Generate performance dashboards and reports to monitor production metrics, quality metrics, and compliance status, facilitating data-driven decision-making and performance analysis.
- **Cross-functional Collaboration:** Facilitate collaboration and communication between production, quality, and other departments, enabling effective information sharing, problem-solving, and decision-making.

The Opvia platform as a Manufacturing Execution System (MES) seamlessly integrates with QMS, quality data management, and batch record capabilities, enabling organizations to streamline production processes, enforce quality controls, and drive continuous improvement for optimized manufacturing operations.

Feel in control of your manufacturing operations with Opvia's tailored MES. Streamline your workflows, gain real-time data insights and meet GMP requirements with ease. 

CDMO / CRO

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