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


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

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

### What is CAPA?

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

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

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

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

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

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

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

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

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


Food & Beverage

CDMO

Pharmaceutical

How an electronic batch recording system helps with CAPA planning

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


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

### What is a DES model?

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

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

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

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

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

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

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

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

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


How an electronic batch recording software can help with DES models

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


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

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

### What are medical DHRs?

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

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

### What is the difference between the two?

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

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


Difference between an electronic batch record and a medical device history record in the pharmaceutical industry?

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


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

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

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

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

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

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

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

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

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

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


Best Practices for a perfect EBR for CDMOs

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

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

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

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

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

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

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

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

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

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

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

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

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

Environmental Testing 

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

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

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

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

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

Cellular Agriculture

Bioreactor Data Capture

In-process testing is one of the most important element in the manufacturing 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 

Inventory management is an essential aspect of any laboratory

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

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

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

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

Laboratory Inventory Tracking

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

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

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

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

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

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

Live Data Sharing between Teams

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

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

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

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

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

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

Live Data Sharing to Customers

Tracking different media formulations and their impact on product quality and cell growth is essential for biotechnology firms

Tracking different media formulations and their impact on product quality and cell growth is essential for biotechnology firms. The composition of growth media significantly influences bioprocess performance, including growth rate, product yield, and overall product quality. The Opvia Cloud Platform empowers firms by providing a user-friendly solution to easily track and analyze various media formulations. It enables comprehensive data recording, organization, and visualization, allowing researchers to identify optimal combinations of nutrients, supplements, and growth factors for maximizing productivity and ensuring consistent quality.

With The Opvia Cloud Platform, teams can efficiently capture and store data on media compositions, growth parameters, and quality metrics. Use intuitive data visualization and analysis tools help uncover trends and correlations, enabling valuable insights into the impact of different media formulations. By streamlining data collection and analysis, Opvia eliminates manual record-keeping, reduces errors, and saves time and resources. It facilitates informed decision-making, accelerates the optimization of media formulations, and streamlines process development, ultimately leading to improved product quality, increased yields, and reduced time-to-market.

Additionally, The Opvia Cloud Platform supports knowledge sharing and collaboration between teams. It establishes comprehensive databases of media formulations and their performance data, enabling easy access to historical records and facilitating comparisons between experiments. This enhances research efficiency, promotes data-driven innovation, and enables faster iteration cycles. By leveraging the power of The Opvia Cloud Platform, biotechnology firms can harness the potential of data-driven optimization, driving advancements in bioprocesses and accelerating the development of high-quality biotech products.

Media Formulation

Stability testing is an aspect of CDMOs or CROs that is often overlooked

Stability testing is an aspect of CDMOs or CROs that is often overlooked. Drug stability testing is crucial for ensuring the safety and efficacy of pharmaceutical products. It evaluates how a drug's quality changes over time, including its potency, purity, and physical characteristics. 

This information is essential for determining appropriate storage conditions, expiration dates, and shelf life. Without proper stability testing, patients could be at risk of receiving ineffective or even harmful drugs.

Stability testing is often conducted over a long period of time (1 - 5 years), and encompasses a large number of experiments - tracking and keeping record of results may be painful or even lost during the process. 

Opvia provides a unique, customisable database that is tailored to your specific stability testing requirements. A wide variety of product-specific information can be logged onto this database, which can be used to keep track of product stability information - no matter the timeframe or number of experiments required.

Stability Testing 

Good sample management practices play a critical role in the success of biotechnology companies

Good sample management practices play a critical role in the success of biotechnology companies. Samples, including cell cultures, biomolecules, and experimental data, are invaluable assets that hold crucial information for research, development, and quality control processes. Effective sample management ensures sample integrity, traceability, and accessibility, facilitating accurate data interpretation, reproducibility, and regulatory compliance. By implementing robust sample management practices, biotechnology companies can safeguard their valuable resources, optimize workflows, and drive scientific advancements and innovation.

Opvia’s cutting-edge sample management software, empowers biotechnology companies to seamlessly implement and optimize their sample management practices. With Opvia, the complex task of handling diverse sample types and associated data becomes effortless, ensuring sample integrity and enhancing overall operational efficiency.

Opvia enables biotechnology companies to track and manage samples with precision. It offers a centralized and intuitive interface for sample registration, labeling, storage location tracking, and retrieval. The software's advanced search and barcode scanning capabilities simplify the process of locating and accessing samples, saving valuable time and minimizing the risk of sample misplacement or loss.

With Opvia, biotechnology companies can establish comprehensive sample repositories, capturing key information such as sample origin, preparation protocols, and storage conditions. This allows for complete traceability, ensuring compliance with regulatory standards and facilitating data reproducibility. The software also provides audit trails and user access controls to maintain data integrity and confidentiality.

Sample Management

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