By Lisa Helmonds, Vice President of Quality and Operations, MWA Consulting, Inc.
Is your company still using paper batch records to manufacture your commercial products? In 2024, there are many affordable solutions to help improve accuracy, reduce your batch record review time, and ensure compliance with current regulations.
Think about how much time it takes to review a complex paper batch record for data entry errors, legibility, and ensuring all specifications are met. Add in the time it takes record the errors you find, send those errors to be corrected by the manufacturing group, review the batch record again to ensure the corrections were made – not to mention the delay in releasing the batch – and you will easily see that electronic batch records will save you a great deal of time and frustration. That’s time that can be better spent on resolving true quality issues, not chasing paper.
Benefits of Electronic Batch Records?
Electronic batch record (EBR) systems offer several benefits over traditional paper-based recordkeeping methods. EBR systems streamline the batch record review process by digitizing documentation and connecting data. This allows for faster access to information and eliminates the need for manual sorting, searching, and filing of paper records. Think about how much easier it is to have digital information that is easier to access, removes the need for maintaining many spreadsheets, and enables efficient and accurate data trending. Furthermore, the reporting capabilities provide insights into batch performance and compliance metrics, which allows you to spend more valuable time supporting your company’s continuous improvement efforts.
Configurable workflows that mirror your unique batch record review processes can provide the most efficient use of your time. This flexibility ensures that the system aligns seamlessly with your existing practices, optimizes efficiency, and adheres to standard operating procedures (SOPs). In addition, EBR systems enable real-time monitoring of production processes and allow for immediate identification and resolution of issues.
Eliminating Paper Boosts Efficiency
Unlike paper-based systems, EBR systems offer robust version control and audit trails, which track changes and document every step of the record review process. This transparency enhances accountability and provides traceability when managing deviations or investigations. Automated document control ensures that only authorized personnel have access to relevant batch records. Version control prevents unauthorized changes and maintains the integrity of the documentation which supports compliance with regulatory requirements. In a paper-based system, version control is a manual process and is prone to error, with no audit trail to aid in deviation investigations. How many deviations have required timely investigations due to using the incorrect version of a batch record, standard operating procedure (SOP), protocol, or other controlled document?
Electronic signatures provide secure and compliant approval of batch records and streamline the review and approval process by eliminating the need for physical signatures, while maintaining a clear audit trail of all sign-off activities. In a paper-based system there can be many extra signature pages that must be scanned by the approver, which can be very inconvenient, and they take extra time to collect, verify, and compile in the batch record.
Saving Time in Batch Record Review Processes
A big time-saver is the real-time collaboration among cross-functional teams involved in batch record review. You can use features such as commenting and task assignments to improve communication and decision-making, which drives efficiency and reduces review cycle times.
Also, EBR systems can integrate with your company’s training management system to ensure that personnel are adequately trained on batch record review procedures and regulatory requirements prior to working on a batch. This integration helps maintain compliance and reduces the risk of errors resulting from inadequate training and manual training verification.
Electronic batch records are designed to meet regulatory requirements, including U.S. Food and Drug Administration (FDA) regulations such as 21 CFR Part 11. Validation services and ongoing support ensure that your EBR system remains compliant and up to date with evolving regulations. Having an experienced support team saves a great deal of time when validating your system, providing a resource to do the heavy lifting.
For all of these reasons, EBR systems help ensure compliance with regulatory requirements by providing a centralized platform for storing, organizing, and managing batch records. This makes it easier for companies to demonstrate adherence to good manufacturing practices (GMP) and other regulatory standards during audits and inspections. It reduces the preparation time for inspections, enables easy access to data, and ensures you can provide the most current information to inspectors.
Conclusion
Overall, EBR systems offer a comprehensive solution for managing batch records, delivering efficiency, accuracy, and compliance benefits that can positively impact operational performance and regulatory compliance. The future is here. We should embrace the changes to reduce the challenges inherent in reviewing paper-based batch records.
For expert advice on implementing EBR systems, contact AVS-MWA Consulting. Our team brings extensive experience in implementing EBR systems, specializing in guiding pharmaceutical, biotech, and medical device companies through successful system deployments. With a proven track record of delivering tailored solutions, AVS-MWA Consulting collaborates closely with electronic batch record solution providers to leverage their expertise and technology, ensuring seamless integration and optimal outcomes for clients.
About the Author
Lisa Helmonds focuses on developing and maintaining relationships with MWA Consulting, Inc. clients, implementing training programs, and ensuring that MWA’s consulting team continues to offer the highest quality services in the industry. Lisa has over 30 years of industrial training in the areas of manufacturing and quality Assurance in the pharmaceutical and medical device industries. She has extensive GxP knowledge, has worked with several startups and large companies, and understands the challenges facing the industry. She holds a B.S. in Zoology from the University of Rhode Island and an MBA from Santa Clara University.
Additional Information
To learn more about MWA’s capabilities please visit our Consulting Services page and contact one of our team members to discuss how we can support your goals ahead. To download a copy of the article please visit MasterControl.