Food & Beverage

CDMO / CRO

Pharmaceutical

Cellular Agriculture

Electronic Batch Records: The Ultimate Guide 

Y﻿our checklist for implementing an Electronic Lab Notebook

Y﻿our checklist for implementing an Electronic Lab Notebook.

ELN Implementation Checklist

Y﻿our checklist for evaluating ELN providers

Y﻿our checklist for evaluating ELN providers.

Chemicals

ELN Vendor Evaluation Checklist

Medical Device

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

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

Y﻿our checklist for implementing a QMS at your organisation

Y﻿our checklist for implementing a QMS at your organisation.

QMS Implementation Checklist

Y﻿our checklist for evaluating QMS vendors

Y﻿our checklist for evaluating QMS vendors.

QMS Vendor Evaluation Checklist

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. 

Industries

Customers

Pricing

Our Story

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?

CAPA is a corrective and preventive action plan that's implemented in a manufacturing process to ensure the quality of the products being produced


CAPA is a corrective and preventive action plan that's implemented in a manufacturing process to ensure the quality of the products being produced.

But having a CAPA plan is just one part of the equation - having a system in place to track and record these corrective and preventive actions is vital. This is where electronic batch recording comes in.

### What is CAPA?

CAPA is short for corrective and preventive action. It's a process that helps identify and address problems before they become big issues. And it's a critical part of any manufacturing process.

But implementing a CAPA plan can be difficult, especially without the right tools. That's where an electronic batch recording system comes in. It can help track batches of product as they move through the process, so problems are quickly identified.

### How can an electronic batch recording system help CAPA planning?

The EBR system can help automate the CAPA process, making it easier and faster to identify and track any potential problems.

An electronic batch recording system can also help generate reports that document the history of each batch of product. This information can be vital in proving that the CAPA plan is effective and helping avoid any costly penalties from regulatory agencies.

### Are there any other benefits of EBR Systems?

An electronic batch recording system can be an important piece of a CAPA plan. But some other benefits of an EBR system are:

- Real-time updates on the manufacturing process, so less time spent on investigating issues and more time fixing them.
- All data will be in one place, running reports is quicker and easier, without having to spend hours compiling information from different sources.

When it comes to ensuring the quality of products, having a corrective and preventive action (CAPA) plan is essential. An electronic batch recording system can help track the history of every product, from production through delivery. This information can be used to evaluate and improve a CAPA plan. Read about Opvia’s EBR software [here](https://www.opvia.io/) and sign up for a demo [here](https://www.opvia.io/contact).


How an electronic batch recording system helps with CAPA planning

When it comes to discrete event simulation (DES), electronic batch recording software can play a big role in recreating a factory in the virtual world


When it comes to discrete event simulation (DES), electronic batch recording software can play a big role in recreating a factory in the virtual world. This type of software is versatile and has various applications, such as scheduling, capacity planning, resource allocation, bottleneck identification, and scenario analysis.

### What is a DES model?

A DES model is a factory in the virtual world. It recreates a sequence of events occurring at discrete time points. Essentially, it helps with planning and characterisation of processes.

But how to use a DES model to improve manufacturing processes? By using an electronic batch recording software. This software can help with data collection, which is essential for building a DES model.

With the right data, manufacturers can optimise their production line and make sure that everything is running as smoothly as possible.

### What are the benefits of using a DES model?

First and foremost, a DES model can help optimise production processes. It can also help identify and fix any bottlenecks in the system. Additionally, with a DES model manufacturers can run different scenarios to see how they would play out—this is a great way to test out different options and make decisions based on data rather than intuition.

Ultimately, using a DES model will help make better, more informed decisions.

### How can an EBR software help with DES models?

An electronic batch recording software can help with DES models by tracking the batches of materials that come into and go out of the factory. This information can then be used to create a more accurate simulation of the factory.

By recording the time, date, and quantity of each batch, the software can help identify any bottlenecks in the production process. It can also help with resource allocation and scheduling, so that the factory can run as efficiently as possible. Read about Opvia’s EBR software [here](https://www.opvia.io/) and sign up for a demo [here](https://www.opvia.io/contact).


How an electronic batch recording software can help with DES models

Electronic batch records (EBRs) are digital records of all the data regarding the drug's development


Electronic batch records (EBRs) are digital records of all the data regarding the drug's development. They can be used to track everything from the ingredients used in a drug to the manufacturing process itself.

This is important because it allows for better quality control and accountability throughout the entire drug development process. It also makes it easier to track adverse effects, as well as any problems that may occur during manufacturing or shipping. In short, EBRs play an essential role in ensuring that drugs are safe and effective when they hit the market.

### What are medical DHRs?

Medical device history records are similar yet the information they track are different. Medical device history records typically contain more detailed information than electronic batch records, such as manufacturing and testing dates, personnel involved, and so on. This includes:

- Information about changes or modifications to a product's specifications or design.
- How was the product designed?
- Who developed the product?
- Where was the product manufactured?
- What tests were performed on the product?

### What is the difference between the two?

Apart from the information that both an EBR and a DHR tracks, both also act at different stages of the medical device lifecycle. An EBR records all the product data prior to manufacturing while a DHR is a production history for a medical device.

Both records have different purposes but require the collection of data throughout the development and manufacturing of the medical device. These records help ensure compliance with regulatory requirements, as well as safety and efficacy of devices. It also allows for traceability of devices throughout the lifecycle, from research to distribution, and ultimately use. Implementation of a MES software that can effectively collect and store relevant information can make the process of EBR and DHR creation easier and faster. Read about Opvia’s EBR software  and sign up for a demo [here](https://www.opvia.io/contact).


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

The global contract development manufacturing organisation (CDMO) industry is growing rapidly


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

Opvia Cloud Platform's CAPA management module provides a robust solution for tracking, investigating, and resolving quality issues


Opvia Cloud 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 Cloud Platform empowers organizations to proactively manage quality, enhance customer satisfaction, and drive overall business excellence.

- **Efficient CAPA Tracking:** Opvia Cloud 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 Cloud 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

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


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 Cloud Platform serves as a powerful solution for efficient and effective audit management


The Opvia Cloud 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 Cloud 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 Cloud 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 Cloud 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 Cloud Platform enables the generation of comprehensive audit reports, providing insights, trends, and areas for improvement.



Opvia Cloud 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 Cloud Platform has change control built-in as first-class functionality


Opvia Cloud 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 Cloud 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 Cloud Platform offers companies in the regulated products industry a powerful data portal to effortlessly share information with their clients


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


Opvia Cloud 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 Cloud 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 Cloud 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 Cloud Platform offers companies in the regulated products industry a robust solution for efficiently tracking and managing client complaints


Opvia Cloud 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

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 Cloud Platform's deviations management module provides a comprehensive solution for tracking, investigating, and resolving deviations within an organization


Opvia Cloud 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 Cloud Platform empowers organizations to enhance their quality assurance practices, minimize deviations, and improve overall operational efficiency.

- **Efficient Deviation Tracking:** Opvia Cloud 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 Cloud 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 Cloud 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 Cloud Platform's document control capabilities empower organizations to effectively manage their documents throughout their lifecycle

Opvia Cloud 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 Cloud Platform provides a comprehensive solution for document control, supporting organizations in their pursuit of efficient and effective quality management.

- **Centralized Document Repository:** Opvia Cloud 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 Cloud 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 Cloud 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


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


The Opvia Cloud 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 Cloud 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 Cloud 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 Cloud 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 Cloud 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


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)


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


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

Label Printing and Control

Inventory management is an essential aspect of any laboratory

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


The Opvia Cloud 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 Cloud 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 Cloud 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 Cloud 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 Cloud Platform supports continuous improvement initiatives, helping organizations identify areas for optimization, reduce waste, and increase productivity.


Opvia Cloud 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


- **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 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. 

Manufacturing Execution System (MES)

Opvia Cloud Platform's OOS management module provides a comprehensive solution for tracking, investigating, and resolving out of specification incidents


Opvia Cloud Platform's OOS management module provides a comprehensive solution for tracking, investigating, and resolving out of specification incidents. With centralized OOS records, automated workflows, root cause analysis capabilities, and real-time collaboration, organizations can effectively address OOS incidents, implement corrective actions, and enhance overall quality assurance. The platform's compliance and audit support further ensures adherence to regulatory standards. Opvia Cloud Platform empowers organizations to streamline their OOS management processes, reduce quality risks, and maintain product quality and compliance.

- **Streamlined OOS Tracking:** Opvia Cloud Platform offers a dedicated module for managing Out of Specifications (OOS) incidents, allowing organizations to efficiently track and document deviations from predefined specifications.
- **Centralized OOS Repository:** The platform provides a centralized repository for storing and managing OOS records, ensuring easy access, traceability, and collaboration across teams involved in investigations and resolution.
- **Root Cause Analysis and Corrective Actions:** The platform enables systematic root cause analysis of OOS incidents, empowering organizations to identify underlying factors and implement appropriate corrective and preventive actions (CAPAs) to prevent recurrence.
- **Real-time Collaboration and Communication:** Opvia Cloud Platform facilitates real-time collaboration among cross-functional teams involved in OOS investigations, promoting efficient communication and knowledge sharing.
- **Compliance and Audit Support:** Opvia Cloud Platform captures and maintains all necessary documentation related to OOS incidents, facilitating compliance with regulatory requirements and supporting audit trails.



Efficient Out of Specifications (OOS) Management for Quality Assurance

Out of Specification (OOS)

The Opvia platform provides robust capabilities to serve as a comprehensive Product Lifecycle Management (PLM) platform

The Opvia platform provides robust capabilities to serve as a comprehensive Product Lifecycle Management (PLM) platform. It supports end-to-end management of product lifecycles, from ideation to retirement, enabling efficient collaboration, data management, and decision-making throughout the product development and manufacturing processes.


- **Centralized Product Data Management:** Store and manage all product-related data in a centralized repository, ensuring easy access, version control, and data consistency.
- **Collaborative Product Development:** Foster collaboration among teams, departments, and stakeholders by providing a shared platform for real-time collaboration, communication, and knowledge exchange.
- **Streamlined Workflows and Processes:** Automate and optimize product development workflows, improving efficiency, reducing errors, and speeding up time-to-market.
- **Requirements and Change Management:** Capture and manage product requirements, track changes, and ensure traceability throughout the development and manufacturing lifecycle.
- **Document Control and Revision Management:** Maintain control over product documents, control document versions, and track revisions to ensure compliance and facilitate audits.
- **BOM and Component Management:** Efficiently manage Bill of Materials (BOMs) and components, track dependencies, and streamline supply chain management.
- **Quality Control and Compliance:** Implement quality control processes, manage product specifications, and ensure compliance with regulatory standards and industry requirements.
- **Data Analysis and Reporting:** Analyze product data, generate reports, and gain insights into performance, quality, and customer feedback to drive data-driven decision-making.
- **Integration with Other Systems:** Seamlessly integrate with other enterprise systems, such as ERP or CRM, to facilitate data exchange and streamline operations.
- **Data Security and Access Control:** Ensure data security, confidentiality, and access control with robust security measures, user permissions, and encryption protocols.

The Opvia platform's capabilities as a Product Lifecycle Management (PLM) solution empower organizations to efficiently manage product lifecycles, enhance collaboration, ensure compliance, and drive innovation throughout the product development and manufacturing processes.

Experience a transformative approach to managing scientific projects with our cutting-edge product lifecycle management tool. From organizing experiments and tracking milestones to centralizing documentation and monitoring progress, our platform provides a holistic solution for efficient project management, ensuring you stay on track and achieve impactful results.

Product Lifecycle Management (PLM)

The Opvia platform offers robust capabilities to support Quality by Design (QbD) implementation, enabling organizations to proactively design quality into their processes and products


The Opvia platform offers robust capabilities to support Quality by Design (QbD) implementation, enabling organizations to proactively design quality into their processes and products. It provides a comprehensive solution for systematic planning, control, and continuous improvement of quality throughout the product lifecycle.


- **Structured Design and Development:** Facilitate a systematic approach to product design and development, ensuring the integration of quality considerations from the early stages.
- **Risk Assessment and Mitigation:** Identify and assess risks throughout the product lifecycle, implementing appropriate mitigation strategies to enhance product quality and patient safety.
- **Real-time Quality Monitoring:** Monitor critical quality attributes and process parameters in real-time, enabling proactive identification of deviations and timely corrective actions.
- **Data-Driven Decision Making:** Leverage data analytics and insights to drive informed decision-making, process optimization, and risk-based quality management.
- **Design Space Exploration:** Conduct systematic experiments and analyses to identify and define the design space that ensures product quality and process robustness.
- **Control Strategy Development:** Develop comprehensive control strategies, including control plans, process monitoring, and in-process controls, to maintain consistent product quality.
- **Change Management and Impact Assessment:** Streamline change management processes, conducting impact assessments and ensuring that changes are implemented in a controlled and validated manner.
- **Regulatory Compliance:** Align with regulatory requirements and guidelines, ensuring compliance with quality standards and facilitating regulatory submissions.
- **Collaboration and Knowledge Sharing:** Foster collaboration among cross-functional teams, promoting knowledge sharing and facilitating effective communication for QbD implementation.
- **Continuous Improvement:** Support continuous improvement initiatives by leveraging QbD principles, data analysis, and feedback loops to drive process optimization and innovation.

The Opvia platform empowers organizations to implement Quality by Design (QbD) methodologies, enabling proactive quality management, data-driven decision-making, and continuous improvement throughout the product development and manufacturing processes.

Opvia for Quality by Design (QbD) Implementation

Quality by Design (QbD)

Opvia Cloud Platform empowers organizations to collect and manage quality assurance data seamlessly


Opvia Cloud Platform empowers organizations to collect and manage quality assurance data seamlessly. By enabling direct data entry, real-time insights, and integration with other quality management modules, Opvia optimizes data accuracy, analysis, and collaboration for enhanced quality control and operational excellence.

- **Efficient Data Collection:** Opvia Cloud Platform provides a user-friendly interface that allows teams to directly edit and execute procedures, enabling real-time data entry and ensuring accuracy and timeliness in quality assurance data collection.
- **Centralized Data Management:** The platform serves as a centralized repository for quality assurance data, facilitating easy storage, organization, and retrieval of information. This promotes data integrity, consistency, and accessibility for effective analysis and decision-making.
- **Real-time Insights and Analysis:** By capturing quality data directly within the platform, Opvia enables immediate access to insights and analysis. Teams can leverage real-time data visualization, reporting, and analytics capabilities to monitor trends, identify potential issues, and make informed decisions promptly.
- **Integrated Quality Management:** Opvia integrates quality assurance data collection and management with other modules within the platform, such as change control, document control, and risk management, fostering a holistic approach to quality management.
- **Enhanced Collaboration and Compliance:** Opvia facilitates collaboration and communication among team members by providing a shared platform for data entry, review, and approval. This ensures compliance with quality standards, promotes cross-functional alignment, and streamlines quality assurance processes.



Streamlined Quality Assurance Data Collection and Management

Quality Data Management

The Opvia Cloud Platform serves as a comprehensive Quality Management System (QMS) solution, offering streamlined processes, centralized data management, and end-to-end visibility


The Opvia Cloud Platform serves as a comprehensive Quality Management System (QMS) solution, offering streamlined processes, centralized data management, and end-to-end visibility. With automated workflows, compliance support, and data-driven decision making, Opvia helps organizations enhance their quality management practices, drive continuous improvement, and ensure the delivery of high-quality products and services to their customers.

- **Streamlined Quality Processes:** Opvia Cloud Platform offers a comprehensive suite of quality management tools and features to streamline your organization's quality processes.
- **Centralized Data Management:** The platform provides a centralized repository for managing all quality-related data, ensuring easy access, traceability, and collaboration across teams.
- **End-to-End Process Visibility:** Opvia Cloud Platform provides end-to-end visibility into your quality processes, allowing you to track and monitor activities, identify bottlenecks, and drive continuous improvement.
- **Automated Workflows and Notifications:** The platform automates workflows and sends notifications for tasks and actions, improving efficiency, reducing manual errors, and ensuring timely completion of quality-related activities.
- **Compliance and Audit Readiness:** Opvia Cloud Platform helps you maintain compliance with regulatory standards by providing robust documentation, audit trail capabilities, and support for regulatory requirements.
- **Data-driven Decision Making:** Leveraging data analytics and reporting capabilities, Opvia Cloud Platform enables data-driven decision making, empowering you to identify trends, insights, and areas for improvement within your quality management processes.



Unlock quality and eliminate risk with the Opvia QMS. Connect and manage everything, from documents and deviations to training and data. 

Quality Management (QMS)

The Opvia Cloud Platform serves as a comprehensive solution for recipe management and optimization in manufacturing


The Opvia Cloud Platform serves as a comprehensive solution for recipe management and optimization in manufacturing. It enables centralized recipe management, supports collaboration, and provides tools for recipe optimization and simulation. With real-time monitoring capabilities, organizations can adjust recipes on-the-fly for optimal performance. The platform also ensures compliance and traceability, helping organizations meet regulatory requirements and maintain quality standards throughout the recipe lifecycle.

- **Centralized Recipe Management:** Opvia Cloud Platform provides a centralized system for managing and storing manufacturing recipes, ensuring consistency and accuracy across production lines.
- **Recipe Version Control and Collaboration:** The platform enables version control of recipes and supports collaborative recipe development, facilitating efficient collaboration and knowledge sharing among teams.
- **Recipe Optimization and Simulation:** Opvia Cloud Platform offers tools for recipe optimization and simulation, allowing organizations to experiment with different parameters and ingredients to achieve optimal product quality and manufacturing efficiency.
- **Real-time Monitoring and Adjustment:** The platform allows real-time monitoring of recipe performance during production, enabling timely adjustments and optimizations to maintain product quality and reduce waste.
- **Compliance and Traceability:** Opvia Cloud Platform ensures compliance with regulatory standards by capturing and documenting recipe changes, providing a comprehensive audit trail for traceability and compliance purposes.



Opvia Cloud Platform for Recipe Management and Optimization: Enhancing Manufacturing Efficiency

Recipe Management

Opvia Cloud Platform empowers companies in the regulated products industry to effortlessly produce comprehensive reports for their clients


Opvia Cloud Platform empowers companies in the regulated products industry to effortlessly produce comprehensive reports for their clients. With Opvia's integrated capabilities and collaborative environment, generating and sharing insightful reports becomes a streamlined process.

- **Centralized Data Management:** Opvia enables companies to centralize all relevant data within a single platform, including quality data, compliance records, and manufacturing information. This centralized approach ensures that client reports are based on accurate and up-to-date data, eliminating the need to search for information across multiple systems.

- **Collaborative Editing and Execution:** Opvia allows teams to collaboratively edit and execute procedures directly within the platform. This means that all necessary data, observations, and actions are captured and documented in real-time, ensuring the accuracy and completeness of the information presented in the reports.

- **Tailored Reporting Templates:** Opvia offers customizable reporting templates that can be tailored to meet specific client requirements. Companies can effortlessly design professional-looking reports that align with their clients' branding guidelines, fostering a cohesive and professional image.

- **Automated Report Generation:** Opvia provides automation features for report generation, allowing companies to schedule and automatically produce reports at predefined intervals. This automation streamlines the reporting process, saves time, and ensures that clients receive timely and consistent updates on their key metrics and performance indicators.

- **Secure and Efficient Report Sharing:** Opvia enables secure sharing of reports with clients through the platform. Companies can control access and permissions, ensuring that reports are shared only with authorized individuals. This enhances data security and provides a seamless and efficient way to deliver reports directly to clients.


Effortless Client Reporting with Opvia Cloud Platform: Seamlessly Delivering Insights to Client

Report Builder

Opvia Cloud Platform offers an integrated risk management solution that empowers organizations to effectively identify, assess, and mitigate risks


Opvia Cloud Platform offers an integrated risk management solution that empowers organizations to effectively identify, assess, and mitigate risks. With seamless integration, holistic risk assessment, real-time monitoring, and automated workflows, organizations can make informed decisions, proactively address risks, and ensure compliance with regulations and industry standards. Opvia Cloud Platform facilitates a robust risk management framework, enhancing decision-making and fostering a culture of risk awareness and accountability throughout the organization.

- **Integrated Risk Management:** Opvia Cloud Platform offers a comprehensive solution for managing risks across the organization, providing a centralized platform that integrates risk assessment, mitigation, and monitoring processes.
- **Seamless Integration:** The platform seamlessly integrates risk management with other modules and functionalities within the system, such as compliance, incident management, and CAPA, ensuring a cohesive approach to risk mitigation and leveraging existing data.
- **Holistic Risk Assessment:** Opvia Cloud Platform enables organizations to perform holistic risk assessments, considering various risk types, such as operational, financial, compliance, and strategic risks, providing a comprehensive view of the organization's risk landscape.
- **Real-time Monitoring and Reporting:** The platform provides real-time monitoring of risks, allowing organizations to track risk levels, assess their impact, and generate reports and dashboards for informed decision-making.
- **Automated Workflows and Notifications:** Opvia Cloud Platform automates risk management workflows, triggering notifications for risk assessments, control effectiveness evaluations, and mitigation plan reviews, ensuring timely actions and proactive risk management.



Integrated Risk Management for Enhanced Decision-making

Risk Management

The Opvia platform provides robust capabilities for sample tracking, offering organizations an efficient solution to manage and track samples throughout their lifecycle


The Opvia platform provides robust capabilities for sample tracking, offering organizations an efficient solution to manage and track samples throughout their lifecycle. It ensures accurate sample tracking, enhances traceability, and streamlines laboratory operations.


- **Centralized Sample Management:** Store and manage sample information in a centralized repository, allowing easy access, organization, and retrieval.
- **Barcode and Label Integration:** Utilize barcode and label printing capabilities to generate unique identifiers for each sample, facilitating automated tracking and identification.
- **Real-time Sample Location Tracking:** Track the real-time location of samples within the laboratory or across multiple locations, ensuring efficient sample handling and minimizing errors.
- **Chain of Custody Management:** Monitor the chain of custody for samples, documenting their movement, transfers, and storage conditions, ensuring data integrity and regulatory compliance.
- **Sample Lifecycle Management:** Track the complete lifecycle of samples, from collection to disposal or archiving, ensuring proper documentation and traceability at each stage.
- **Sample Status and Workflow Monitoring:** Monitor the status of samples, track their progress through various laboratory processes, and gain insights into workflow bottlenecks or delays.
- **Alerts and Notifications:** Set up automated alerts and notifications for sample-related events, such as approaching expiration dates or completion of specific analysis, ensuring timely actions and follow-ups.
- **Data Integration and Analysis:** Integrate sample tracking data with other laboratory systems or analysis tools for comprehensive data analysis, enabling data-driven decision-making and process optimization.
- **Reports and Audit Trails:** Generate reports and audit trails for sample tracking activities, facilitating compliance audits, quality control assessments, and regulatory submissions.
- **Collaboration and Communication:** Enable seamless collaboration among laboratory personnel, allowing communication, data sharing, and annotations related to sample tracking and analysis.

The Opvia platform's sample tracking capabilities streamline laboratory operations, enhance sample traceability, and facilitate efficient management of samples, ensuring data integrity and compliance in research, development, and quality control processes.

Imagine a world where sample tracking is effortless, error-free, and easily accessible. With our innovative sample tracking tool, you can transform your laboratory operations, ensuring the smooth movement and accurate documentation of your samples throughout their lifecycle. Embrace a new era of efficiency, compliance and confidence in your research.

CDMO / CRO

Feeling the pressure to deliver?Gain your competitive advantage and provide your clients with actionable insights.

Request consultation