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Comprehensive Checklist for Bioprocessing Data Ontology

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.

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ELN Vendor Evaluation Checklist

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Good Laboratory Practices (GLP): The Ultimate Guide

Good Manufacturing Practices (GMP): The Ultimate Guide

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Y﻿our checklist for implementing a LIMS.

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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

Selecting the right QMS software is a strategic decision that could transform your day-to-day, and the direction of your company. Download the "QMS Selection Checklist" now to grab your own compass in the challenging journey of vetting software.

Selecting the right QMS software is a strategic decision that could transform your day-to-day, and the direction of your company. Download the "QMS Selection Checklist" now to grab your own compass in the challenging journey of vetting software.

What questions do you ask in a demo for a QMS? What things should you look out for when going through the process of choosing the right QMS? We hope this guide gives you the direction you need in finding the right QMS for you.

QMS Selection Checklist

Y﻿our checklist for evaluating QMS vendors.   .

Y﻿our checklist for evaluating QMS vendors.

QMS Vendor Evaluation Checklist

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 Pharmaceutical 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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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

When it comes to tracking quality, often times Quality Managers find themselves struggling with paper processes, or indebted to the dreaded process we call “Folder Hopping”.

When it comes to tracking quality, often times Quality Managers find themselves struggling with paper processes, or indebted to the dreaded process we call “Folder Hopping”. Whether it’s pen and paper to track these crucial quality standards or hopping from folder to folder on your computer to find documents and data, both options fall short of the capabilities of a QMS. 

A Quality Management System (QMS) is an automated structured framework and set of processes designed to ensure that an organization consistently meets or exceeds the quality standards and requirements of its products or services. A good QMS provides a systematic approach to quality control and management, with the goal of enhancing customer satisfaction, reducing errors and defects, and improving overall operational efficiency. They do this by centralizing and making data come alive. Or at least the good ones do. 


Why would you consider a QMS:

1. **Consistency:** A QMS ensures that quality standards are consistently met across the organization, which is essential for providing reliable products or services to customers. Consistency in quality can enhance a company's reputation and customer trust.

2. **Regulatory Compliance:** Many industries have strict regulatory requirements. A QMS helps organizations ensure compliance with industry standards and regulations, reducing the risk of legal issues or product recalls.

3. **Continuous Improvement:** QMS encourages a culture of continuous improvement. By monitoring processes and measuring results, organizations can identify areas for enhancement and make data-driven decisions to drive quality improvements.

4. **Efficiency:** QMS reduces the occurrence of errors, defects, and waste in production or service delivery. This leads to increased operational efficiency, lower costs, and higher productivity.

5. **Customer Satisfaction:** Meeting and exceeding customer expectations is a central goal of a QMS. Customer feedback is used to drive improvements, resulting in products and services that better align with customer needs.

6. **Risk Management:** A QMS includes risk management processes, which help organizations identify, assess, and mitigate risks that could impact the quality of their products or services.

7. **Employee Engagement:** QMS encourages involvement from employees at all levels. Employees are often more engaged and motivated when they are part of an organization that values and prioritizes quality.

8. **Transparency:** QMS fosters transparency within an organization, making it easier to track and trace quality-related processes and 
documentation.


So it begs the question. How to take the next step in searching for the QMS that fits you best?

Selecting the right QMS software is a strategic decision that could transform your day-to-day, and the direction of your company. Download the "QMS Selection Checklist" now to grab your own compass in the challenging journey of vetting software. 

What questions do you ask in a demo for a QMS? What things should you look out for when going through the process of choosing the right QMS? We hope this guide gives you the direction you need in finding the right QMS for you.

What is a QMS and why should you use one?

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!


AI can help identify inefficiencies in manufacturing processes and suggest ways to optimise them. AI can also be used to monitor production data and make predictions about future outcomes.


AI can help identify inefficiencies in manufacturing processes and suggest ways to optimise them. AI can also be used to monitor production data and make predictions about future outcomes.

Electronic batch records play a key role in facilitating the implementation of AI techniques.

Here's how it works: the electronic batch record is used to capture all the data related to the manufacturing process, from raw materials to the finished product. This data is then analysed by AI software, which can identify patterns and trends that would otherwise be missed. This information can then be used to improve the manufacturing process, making it more efficient and productive.

### How electronic batch records can be used to facilitate the implementation of machine learning algorithms

Electronic batch records can play a crucial role in the implementation of machine learning algorithms in the manufacturing process.

Machine learning algorithms need large data sets in order to be effective. Electronic batch records provide a comprehensive history of all the batches that have been produced, which can be used to train the machine learning algorithm.

The electronic batch record also contains information about the recipe that was used to produce the batch, and this information can be used to verify that the machine learning algorithm is producing accurate results.

### The benefits of using electronic batch records to implement AI techniques

1. **Accuracy**: When data is entered into an electronic batch record, it's immediately validated for accuracy. This means that there's no margin for human error, which can lead to mistakes in the manufacturing process.
2. **Traceability**: Electronic batch records create a paper trail that can be traced back to the source. This is helpful for troubleshooting and quality control purposes.
3. **Efficiency**: With electronic batch records, manufacturers can track production data in real-time. This allows them to respond quickly to any issues that may arise and make necessary adjustments.
4. **Insight**: By analysing production data, manufacturers can gain valuable insights into their manufacturing processes. This helps them to identify areas where they can make improvements and optimise their operations.

### The future of electronic batch records and AI-enabled manufacturing processes

Electronic batch records play a key role in ensuring the accuracy and consistency of data during the manufacturing process. They also provide a record of the manufacturing process, which can be used to verify that the product meets the required specifications.

But that's just the beginning. In a future where AI techniques are used in manufacturing processes, Electronic batch records will become even more important. They will be essential for ensuring that the data is processed correctly and that the products meet the required standards.

By maintaining an accurate and up-to-date record of all the batches that have been produced, electronic batch records make it possible to identify any changes or deviations in the manufacturing process. This can then be used as the basis for training and deploying AI models. But that's not all; electronic batch records can also play a role in verifying the accuracy of the predictions made by those AI models. In other words, they can help to ensure that the decisions made by AI-enabled systems are trustworthy and reliable. Read about Opvia’s EBR software [here](https://www.opvia.io/) and sign up for a demo [here](https://www.opvia.io/contact).


How electronic batch records facilitate the implementation of AI techniques

Canada's cannabis industry has undergone a profound transformation, propelled by regulatory frameworks enforced by Health Canada. As the nation embraced the legalization of cannabis for medical and recreational use, the regulatory body, Health Canada, established stringent guidelines to ensure quality, safety, and compliance within this burgeoning sector.

Canada's cannabis industry has undergone a profound transformation, propelled by regulatory frameworks enforced by Health Canada. As the nation embraced the legalization of cannabis for medical and recreational use, the regulatory body, Health Canada, established stringent guidelines to ensure quality, safety, and compliance within this burgeoning sector.

Health Canada mandates various forms crucial for businesses operating in the cannabis space. These forms encompass licensing applications, production reports, security clearances, and product-related documentation. Navigating this regulatory landscape demands meticulous attention to detail and a robust Quality Management System (QMS) that aligns with Health Canada's rigorous standards.

A QMS serves as the backbone for ensuring adherence to regulatory protocols. It enables cannabis companies to document, monitor, and continually improve their processes, thereby meeting the stringent requirements set by Health Canada. Implementing a comprehensive QMS streamlines operations, fosters consistency in quality, and significantly reduces the risk of non-compliance.

Moreover, traceability stands as a cornerstone in the cannabis industry, allowing companies to track products throughout the supply chain. A robust traceability system enables swift identification and resolution in case of any safety concerns or product recalls. Should a situation arise necessitating a recall due to quality issues or regulatory non-compliance, an efficient traceability system integrated into the QMS becomes invaluable.

Imagine a scenario where a cannabis product requires immediate recall due to potential contamination. With a well-integrated QMS and traceability system, companies can swiftly pinpoint affected batches, trace their distribution, and promptly communicate the issue to regulators and consumers. This swift action not only mitigates potential health risks but also safeguards brand reputation and consumer trust.

Furthermore, a proactive approach to traceability allows for thorough investigations into the root causes of issues, facilitating continuous improvement in processes to prevent similar incidents in the future. This commitment to safety and compliance not only meets Health Canada's stringent requirements but also sets a precedent for responsible business practices within the industry.

In conclusion, the cannabis industry in Canada operates within a highly regulated environment overseen by Health Canada. Compliance with the requisite forms and standards is non-negotiable. Implementing a robust QMS and a comprehensive traceability system not only ensures regulatory adherence but also serves as a proactive measure to safeguard consumer safety and company reputation. Companies that invest in these systems demonstrate their commitment to quality, compliance, and the well-being of consumers, setting a standard of excellence within this evolving industry.

#### A﻿bout Opvia

Opvia stands at the forefront of empowering regulated companies with Quality Management Solutions (QMS) designed to navigate the complexities of regulatory compliance. Through its innovative systems, Opvia assists companies in implementing robust QMS frameworks tailored to the unique demands of the cannabis industry, ensuring seamless adherence to Health Canada's stringent standards. By harnessing Opvia's expertise, companies can streamline operations, enhance product quality, and bolster safety measures, thereby expediting the delivery of superior, trustworthy cannabis products to the market. With Opvia, businesses pave the way for innovation, reliability, and consumer confidence in this rapidly evolving landscape.

Documenting Success: Crucial Forms for Regulatory Adherence in Canada's Cannabis Sector

When it comes to developing active pharmaceutical ingredients (APIs), efficiency and reliability are key. That's where an electronic batch record comes in.


When it comes to developing active pharmaceutical ingredients (APIs), efficiency and reliability are key. That's where an electronic batch record comes in.

An electronic batch record can help you streamline your API development process and ensure accuracy and compliance.

### Process of active pharmaceutical ingredient development

An electronic batch record is a digital system that helps you track and document every step of the API development process. It's a great way to ensure that all the ingredients are mixed together in the right proportions, and that the finished product meets all the relevant quality standards.

Using an electronic batch record can also help you speed up the approvals process, since providing regulators with all the documentation they need is easier. With regards to selling the product, an EBR can prove to buyers that your product is of the highest quality.

### Benefits of using an EBR

Electronic batch records have a lot of benefits when it comes to active pharmaceutical ingredient (API) development.

For starters, they help keep track of all the stages of the development process. Every step is recorded, from the initial formulation to the final product. This level of detail is essential for ensuring that the product is safe and compliant with all regulatory standards.

But electronic batch records don't just help you keep track of what's happening; they also help you optimize your operations. By automating many of the tasks that are traditionally done by hand, time and money is saved whilst maintaining consistent data.

Some of the benefits include:

- An electronic batch record can help you keep track of all the steps in the development process. This way, one can be sure that everything is being done correctly and that all the necessary safety measures are in place.
- It also makes it easier to share information with teams. With everyone having access to the same information, there's less chance for confusion or miscommunication.
- An electronic batch record can help save time and money. By streamlining the development process, the amount of time it takes to bring a product to market is reduced.
- EBRs track all production batches and make sure that everything is being done according to protocol. This is especially important during the development phase, when mistakes can be costly.
- It also helps with data management, QA/QC, and communication.

### Advantages of using an EBR

1. **Accuracy**: An electronic batch record ensures that all data is captured and recorded accurately, without the risk of human error.
2. **Security**: The records are stored in a secure location and can be accessed at any time.
3. **Efficiency**: The automated process eliminates the need for manual data entry, which can lead to mistakes.
4. **Traceability**: The electronic batch record can be used to trace the history of a batch of API, from beginning to end.
5. **Flexibility**: The electronic batch record can be customized to meet the specific needs of your organization.

An electronic batch record can be a huge help during the Active Pharmaceutical Ingredient Development process. By using an electronic batch record, all data is stored in one place, making it easy to access and track. This can help to reduce mistakes and speed up the development process. Read about Opvia’s [here](https://www.opvia.io/) and sign up for a demo [here](https://www.opvia.io/contact).


The API development process and how an EBR can help

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?

Cell therapies are highly complex and personalised treatments, involving the manipulation and administration of living cells to patients.  Batch records serve as a detailed documentation of the entire manufacturing process, capturing critical information such as cell sourcing, cultivation, processing and quality control measures.

Cell therapies are highly complex and personalised treatments, involving the manipulation and administration of living cells to patients. 

Batch records serve as a detailed documentation of the entire manufacturing process, capturing critical information such as cell sourcing, cultivation, processing and quality control measures. These records provide a comprehensive overview of each batch, allowing for traceability, reproducibility and regulatory compliance. 

Quality Management Systems establish rigorous standards and processes to monitor and control various aspects of cell therapy manufacturing, including facility design, personnel training, raw material management and product testing. 

By adhering to stringent quality management practices and maintaining accurate batch records, manufacturers can identify and mitigate potential risks, ensure consistent product quality and ultimately enhance patient safety and therapeutic outcomes in the field of cell therapy. 

Opvia empowers manufacturing teams to easily create, manage and execute batch records digitally, ensuring accuracy, traceability and efficiency every step of the way. With its intuitive interface and customisable workflows, Opvia adapts to your needs, seamlessly integrating with existing Opvia solutions. 

Experience enhanced data integrity, real-time visibility and automated reporting, while reducing errors and compliance risks. Stay ahead in the competitive landscape with Opvia, your partner in driving operational excellence and maintaining GMP compliance effortlessly.

<div style="position: relative; padding-bottom: calc(51.24999999999999% + 41px); height: 0; width: 100%"><iframe src="https://demo.arcade.software/xhKknfeR4yvmPmWCBqVW?embed" frameborder="0" loading="lazy" webkitallowfullscreen mozallowfullscreen allowfullscreen style="position: absolute; top: 0; left: 0; width: 100%; height: 100%;color-scheme: light;" title="Manufacturing Execution Records"></iframe></div>

Cell Therapy Manufacturing

Testing dose responses from candidate compounds play a crucial role in pharmaceutical research and development, as well as in clinical practice. They help us understand the potency and efficacy of a drug, optimising dosing regiments and ensuring patient safety.

Testing dose responses from candidate compounds play a crucial role in pharmaceutical research and development, as well as in clinical practice. They help us understand the potency and efficacy of a drug, optimising dosing regiments and ensuring patient safety.

By evaluating the relationship between dose and response, researchers can gain valuable insights into the therapeutic effects of a hit compound. 

The dose-response relationship explores how the concentration of a drug influences its biological response or effect. It involves exposing cells to various concentrations of a drug and measuring the biological or physiological response. This process helps identify the optimal drug concentration or dosage range that produces the desired therapeutic effect whilst minimising any potential adverse effects. 

Determining the EC50 is a fundamental outcome of dose-response analysis. The EC50 represents the concentration of a drug required to produce a halfway response between the baseline and maximum effect. It serves as a quantitative measure of the potency. 

Opvia simplifies the process of running primary screening assays, enabling instant visualisation of dose-response curves and auto-determination of EC50s, making it an indispensable tool in the field of drug discovery. With Opvia, comparing candidate compounds during primary screening becomes effortless and efficient.

Determining EC50s

In the field of drug discovery, the identification and development of novel compounds with desired pharmacological properties is a complex and challenging task. One crucial aspect of this process involves comparing the EC50 (half-maximal effective concentration) and LogP (octanol-water partition coefficient) values for various candidate compounds.

In the field of drug discovery, the identification and development of novel compounds with desired pharmacological properties is a complex and challenging task. One crucial aspect of this process involves comparing the EC50 (half-maximal effective concentration) and LogP (octanol-water partition coefficient) values for various candidate compounds. This comparative analysis plays a significant role in evaluating the potential of these compounds and determining their suitability for further development.

The EC50 value represents the concentration of a compound required to achieve a response halfway between baseline and maximum effect. It is commonly used to measure the potency or efficacy of a drug candidate. By comparing the EC50 values of different compounds, drug discovery scientists can gain insights into their relative potency and select the most promising candidates for further investigation. Compounds with lower EC50 values are generally considered more potent, as they require lower concentrations to produce the desired therapeutic effect.

On the other hand, LogP is a measure of the compound's lipophilicity, indicating its ability to dissolve in lipids or fats. It represents the logarithm of the ratio of a compound's concentration in the organic phase (usually octanol) to its concentration in the aqueous phase (usually water). LogP is an essential physicochemical parameter in drug discovery, as it influences the compound's absorption, distribution, metabolism, and excretion (ADME) properties. Compounds with appropriate LogP values are more likely to possess favorable pharmacokinetic characteristics, allowing for better tissue penetration, optimal distribution, and increased bioavailability.

When comparing EC50 and LogP values for candidate compounds, drug discovery scientists can draw important conclusions regarding their potential therapeutic efficacy and drug-likeness. Ideally, an effective drug candidate should possess both desirable potency (low EC50) and appropriate lipophilicity (optimal LogP). A compound with a low EC50 and balanced LogP value suggests a higher likelihood of achieving the desired pharmacological effect at a lower dosage, which can lead to reduced toxicity and improved patient compliance.

Moreover, comparing EC50 and LogP values is crucial for making informed decisions during the lead optimization phase. Drug discovery companies often encounter multiple candidate compounds with varying potencies and lipophilicities. Through careful analysis and comparison of these parameters, scientists can prioritize compounds that exhibit a favorable balance between potency and lipophilicity. This comparative evaluation ensures that the selected compounds have a higher likelihood of success during subsequent stages of development, such as in vivo studies, safety evaluations, and clinical trials.

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EC50 v LogP

Hormones play a critical role in regulating various physiological processes and maintaining homeostasis in the body. By assessing the impact of drug compounds on hormone levels, researchers can gain insights into the compound’s potential effects on endocrine function, hormonal balance and overall health.

Hormones play a critical role in regulating various physiological processes and maintaining homeostasis in the body. By assessing the impact of drug compounds on hormone levels, researchers can gain insights into the compound’s potential effects on endocrine function, hormonal balance and overall health. This information is crucial for evaluating the safety, efficacy and potential side effects, as well as for developing targeted therapies for hormone-related disorders.

Opvia empowers researchers with the ability to effortlessly aggregate data from animal studies and automate plotting and analysis. Through centralising data in one database, researchers can instantly uncover valuable insights, identify trends and make informed decisions with confidence.

<div style="position: relative; padding-bottom: calc(51.31944444444444% + 41px); height: 0; width: 100%"><iframe src="https://demo.arcade.software/H97dsMCOf3SwWFZrQacN?embed" frameborder="0" loading="lazy" webkitallowfullscreen mozallowfullscreen allowfullscreen style="position: absolute; top: 0; left: 0; width: 100%; height: 100%;color-scheme: light;" title="In Vitro Animal Studies"></iframe></div>

Endocrine In Vivo Studies

Bioprocesses are complex and require high qualoty standards that must be managed and controlled efficiently. EBRs are a great option are offer many advantages including: - Speed up the process - Improve accuracy and compliance - Makes data entry easier.


Bioprocesses are complex and require high qualoty standards that must be managed and controlled efficiently. EBRs are a great option are offer many advantages including:

- Speed up the process
- Improve accuracy and compliance
- Makes data entry easier
- Reduction in time it takes to produce reports

With the right software in place, you can streamline the batch record process and make it more efficient than ever before.

### How to implement an EBR?

There are a few key things to keep in mind when implementing an electronic batch record system in a biotech company.

1. **Work with the right software vendor**: Make sure to work with a vendor that is knowledgeable about the specific regulations and compliance requirements for the biotech industry. They should also be able to provide a system that is easy to use and navigate, so that your team can effectively manage your batches using the electronic records.
2. **Train your team**: Once you have the system in place, it's important to train your team on how to use it.
3. **Be prepared for a learning curve**: Change doesn't always come easy, and there may be a bit of a learning curve as everyone adjusts to using the new electronic batch records system.

### Benefits of an EBR

There are many benefits to implementing an electronic batch record system in your biotech company. With an electronic system, all of your data is housed in one secure location, which makes it easy to track and monitor batches from start to finish. This not only saves time and money, but it also ensures that the batches are processed accurately and efficiently.

An electronic batch record system can also help you to reduce errors and improve quality control. By tracking each step of the production process, any issues are quickly found and saved.

### Future of EBRs

The future of electronic batch records is looking bright. With more and more biotech companies moving to electronic batch recording, the benefits are clear. Here are just a few of the ways electronic batch records can help:

- **Ease of Use**: Electronic batch record systems are designed for ease of use, making them simple to learn and operate.
- **Faster Updates**: With an electronic system, updates can be made quickly and easily, ensuring that your records are always up-to-date.
- **Accurate Records**: Electronic systems provide a precise and accurate record of each batch, ensuring that all information is accounted for.
- **Reliable Storage**: Records are stored electronically, meaning they are safe and secure.

Electronic batch records have revolutionised the way biotech companies operate, providing an efficient and reliable way to track and monitor batches of product. Read about Opvia’s EBR software  and sign up for a demo [here](https://www.opvia.io/contact).


Streamlining the batch record process with EBRs: a how-to guide for biotech companies

The pharmaceutical industry is one of the most sensitive industries when it comes to product recalls. This is because a recall can have a huge negative impact on not only the company's reputation, but also on the health of its customers.


The pharmaceutical industry is one of the most sensitive industries when it comes to product recalls. This is because a recall can have a huge negative impact on not only the company's reputation, but also on the health of its customers.

To maintain high quality in electronic batch records (EBRs), companies need to take a number of measures. These include ensuring that all data entered into EBRs is accurate and up-to-date, ensuring that all batch records are properly tagged and filed, and monitoring production processes closely to ensure that no errors or deviations occur. If there is any potential issue with a batch of medication, it is important for the pharmaceutical company to immediately identify and correct it. This can be done through EBRs, which provide detailed information about each step of the manufacturing process.

In addition to the quality controls within the EBR system, another benefit is that it makes batch record reviews quicker and faster. Batch record reviews (BRRs) are a vital step in the pharmaceutical industry that help ensure that all quality and compliance rules are met. They're also a way to identify any potential problems with the drug product before it's released to the public.

### What are batch record reviews?

BRRs are carried out by inspectors at the level of batch, lot, or package. They check to make sure that all steps in the manufacturing process have been followed correctly and that all specifications for the drug have been met. This includes checking for any potential safety issues, verifying ingredients and quantities, and assessing whether any deviations from normal manufacturing procedures have occurred.

### How does an EBR help with BRRs?

Electronic batch records make batch record reviews (BRRs) much faster and easier. By tracking all the required data in an EBR system, BRRs can be quickly and easily performed. This means that every piece of information is available at your fingertips, making it easy to determine whether or not all quality and compliance rules have been followed.

An EBR system also makes it easy to identify any problems early on, before they become serious. This means that you can take corrective action quickly and ensure that everything is running smoothly from start to finish prior to these issues being flagged in a review.

BRRs are an important part of ensuring the quality and safety of drugs, and they play an integral role in keeping patients safe. By conducting regular reviews, pharmaceutical companies can avoid any unforeseen problems and the implementation of an EBR system facilitates this process. Read about Opvia’s EBR software  and sign up for a demo [here](https://www.opvia.io/contact).


How does an EBR help with faster batch record reviews in the pharmaceutical industry?

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?

The food and beverage industry is one of the economy's largest industries globally generating millions of goods each day. However the perishable nature of these products means that quality control throughout the supply chain is vital to avoid costly mistakes and product recalls.


The food and beverage industry is one of the economy's largest industries globally generating millions of goods each day. However the perishable nature of these products means that quality control throughout the supply chain is vital to avoid costly mistakes and product recalls.

![](media/screen-shot-2022-08-19-at-5.21.55-pm.png)

### Here are some benefits of using an EBR:

1. **Traceability:** This is imperative for manufacturers that produce products that contain allergens along with allergens-free versions in the same facility. Traceability controls within an EBR system are vital to ensuring no cross contamination occurs throughout the production process. The controls include the system enforcing the correct ingredients and packaging materials that are used for a specific batch of a product.

![](media/screen-shot-2022-08-19-at-5.22.44-pm.png)

1. **Compliance:** Regulatory compliance within the food industry is very stringent and constantly changing. Keeping up to date with these changes is easily done on a software solution that is more transparent and flexible. Changing guidelines are calling for greater transparency in the manufacturing processes. For example, the Federal Trade Commission is also set to set out new guidelines this year to make sure companies are more transparent with their processes along with also having reliable evidence for their claims. This is forcing manufacturing productions to rethink their supply chains and product life cycles. These guidelines can be better enforced and communicated using a digital solution. For example, the temperatures of perishable goods must be recorded throughout the stages of manufacturing and production and this can be better recorded and managed on an EBR.
2. **Stock Management:** Efficient management of perishable stock is vital when fresh ingredients reach the production stage. Features in an EBR such as batch-tracking, predictive stock management makes this easier and more sustainable without any wastage.
3. **Analysis:** Using an EBR, all the data is stored in a synchronous format which makes it easier to organise and analyse in the future. This analysis can be useful for optimization of the product or the manufacturing process.

The digitization of this process driven industry is paving way for necessary changes to ensure quality assurance and compliance which in turn reduce costs for the company.

Opvia’s no-code EBR solution is a simple yet effective solution that can be made to fit for various manufacturing processes in the F&B industry. Following from the points discussed in this article some features included are registries, electronic signatures, and the ability to easily connect data samples. Read more about Opvia’s solution .


Benefits of using an EBR in the food and beverage industry

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

It is estimated that ~1-5% of compounds pass the hit-to-lead identification process during discovery. Not only does the low transfer rate slow down discovery, but also adds a significant cost burden, especially to early stage start-ups.

It is estimated that ~1-5% of compounds pass the hit-to-lead identification process during discovery. Not only does the low transfer rate slow down discovery, but also adds a significant cost burden, especially to early stage start-ups. 

Biotechs around the globe are searching for ways of maximising their success rate to speed up development and minimise costs. 

One method of accelerating this discovery is through information centralisation.

Storing compounds in a well-structured and comprehensive database is of paramount importance to drug discovery companies. Such databases provide a powerful platform for managing and organising an array of chemical compounds and their data. 

By centralising this information, companies can enhance their R&D efforts by efficiently accessing and exploring compound data, facilitating faster hit-to-lead decision-making and accelerating the discovery of novel therapeutic candidates. 

## Build a custom database to manage your assets on Opvia

Opvia’s intuitive and flexible interface allows trailblazing drug-discovery teams to seamlessly aggregate and display the information of choice of a compound library, including chemical structures, inventory information and assay / study data from every step of the development and manufacturing pipeline. 

Opvia transforms the drug discovery landscape, enabling companies to rapidly identify promising candidates and ultimately accelerate the discovery process. 

<div style="position: relative; padding-bottom: calc(51.388888888888886% + 41px); height: 0; width: 100%"><iframe src="https://demo.arcade.software/xrMQIrCyevgzrNSRDuLf?embed" frameborder="0" loading="lazy" webkitallowfullscreen mozallowfullscreen allowfullscreen style="position: absolute; top: 0; left: 0; width: 100%; height: 100%;color-scheme: light;" title="Compound Management"></iframe></div>

Compound Management

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)

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

In-process testing is one of the most important element in the manufacturing process. It is critical to ensuring that products meet quality standards throughout the manufacturing process.  By testing products at various stages of production, manufacturers can identify issues early on and make adjustments to prevent defects from occurring later in the process.

In-process testing is one of the most important element in the manufacturing process. It is critical to ensuring that products meet quality standards throughout the manufacturing process. 

By testing products at various stages of production, manufacturers can identify issues early on and make adjustments to prevent defects from occurring later in the process. This can save time and money by reducing the need for rework and minimising the risk of product recalls.

Explore how Opvia enables visibility across QC testing of process samples.

Opvia is a powerful tool that enables visibility across QC testing of process samples - it enables you to build comprehensive dashboards that allows you to view all of your process samples at a glance. With Opvia, you can easily track the status of each sample, monitor progress, and ensure that all tests are completed on time.

Opvia also provides detailed analytics and reporting tools, allowing you to identify trends and patterns in your testing data. By streamlining your QC experiments into one platform, you are also able to quickly generate reports for internal review or send to customers, if needed.

In Process Testing 

In-vitro ADME PK studies play a critical role in drug discovery. These studies involve the use of laboratory techniques to investigate how a drug candidate is absorbed, distributed, metabolised and eliminated within a living organism.

In-vitro ADME PK studies play a critical role in drug discovery. These studies involve the use of laboratory techniques to investigate how a drug candidate is absorbed, distributed, metabolised and eliminated within a living organism.

By assessing these pharmacokinetic properties early in the drug development process, researchers can gain valuable insights into the drug’s behaviour, efficacy and safety profile. In-vitro ADME PK studies help identify potential issues related to drug absorption, metabolism, drug-drug interactions and toxicity allowing scientists to make informed decisions about drug candidates and optimise their properties for proceeding with further studies.

Managing, analysing and visualising drug stability data across different species is of paramount importance in drug development. Understanding the stability of a drug candidate across various species provides critical insights into its behaviour, degradation pathways and potential adverse effects. 

Visualising this data through graphical representations helps in interpreting complex stability information and aids in decision-making during pre-clinical development, ultimately ensuring the safety and efficacy of the drug in diverse patient populations. 

Opvia empowers you to unlock the true potential of your drug stability data through instant insights, revolutionising the way you navigate the complexities of drug development.

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ADME PK Studies

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

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.

Pharmaceutical

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