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Advanced electronic batch recording (EBR) manages workflows and recordkeeping for compliance and production efficiency.
Phonebooks may be a thing of the past, but the transition from paper to digital systems is still rolling out across many industries. Exhaustive paper documentation became the status quo in the pharmaceutical industry to satisfy regulatory documentation requirements. But paper-based systems are time consuming. They increase cost per batch and can introduce risk in the form of human error.
In the pharmaceutical industry, electronic batch recording (EBR) systems are more agile, but even as digital records became the “master,” the systems continued to be used for the same tasks. Today’s EBR systems, however, are evolving from paper-on-glass to advanced solutions.
Integration with the manufacturing execution system (MES) means EBR can offer capabilities such as order management between an enterprise business and real-time control systems. It provides the ability to manage workflows and recordkeeping for everything from recipe creation to batch qualification. Automated workflows, consumable and real-time information, and compliance support are the marks of modern EBR.
Pharmaceutical manufacturing relies on processes that must be precisely followed to ensure a consistent batch quality. To meet this need, EBR systems must be able to integrate with current control-level systems.
What does this mean day to day? As orders are entered into a company’s enterprise resource planning (ERP) system and distributed to the facility, individualized and context-specific instructions are provided to production operators. These instructions include information that ensures the enforcement of required processes and procedures, such as required sign-offs for submission of batch records to regulatory agencies.
Automating and enforcing workflows enables real-time data collection. As a batch moves across the facility, information tailored to its recipe is communicated to relevant employees, which can increase the efficiency of production. In the case of a process exception, operators are notified during the actual production process, rather than seeing it in EBR post production. Then, they can make necessary changes to improve batch accuracy and consistency.
This seamless flow of information also reduces human error from manual recordkeeping. This meets a pharmaceutical manufacturer’s need for complete and correct records.
Ensuring proper documentation is a non-negotiable component of pharmaceutical manufacturing. Without a record, product cannot be sold. It’s also becoming more complex as producers are required to meet standards in a multitude of countries.
Regulators place high demands on pharmaceutical manufacturers. Data on operating conditions, materials used, and equipment and processes used all must be qualified and validated. As mentioned, exceptions are noted during production. This record of exceptions can then be directly accessed by quality assurance teams. By performing a review by exception, these teams can focus on the deviations instead of sifting through reams or screens of documentation line by line.
The sheer amount of information reported also makes satisfying regulators difficult. A pharmaceutical manufacturer is often required to keep records for at least one year. The costs of archiving all these documents add up when using a paper-based system. Even electronic records of such magnitude can be cumbersome if trying to retrieve specific information. Advanced EBR systems reduce the physical space needed for storage and make it easier to find archived information.
Life after the paper age
Integration with MES brings EBR technology well beyond the paper age. Like every exciting technology, users benefit most when it fits into their daily lives. When deploying an EBR system to replace paper in operations, pharmaceutical manufacturers should start to look at how far these solutions can take them beyond replicating the functionality of paper EBR on glass.
About the author
Martin Dittmer is PharmaSuite product manager, Rockwell Automation, firstname.lastname@example.org.