Using Electronic Batch Records to Their Full Potential

By replacing paper-based workflows with computer-based workflows, biopharma companies reduce the risk of human error and sped up compliance processes. But the move to an electronic batch record (EBR) system can do far more than digitize paper-based workflows and recordkeeping.

When integrated into a scalable manufacturing execution system (MES), EBRs become more dynamic and can support operations in new ways. This is especially true as operations move toward a connected enterprise, wherein production and business systems are fully connected and can seamlessly share information.

When an MES with EBRs is brought into a connected ecosystem, it can begin to access enterprise-wide information, deliver role-based instruction to workers, and provide exception-based reporting. This access can help speed up time-to-market, cut costs in multiple areas, and ease or even improve demonstrated compliance.

Improve time-to-market

An MES that offers modern and dynamic EBRs can help accelerate time-to-market in multiple ways. In the words of one pharma producer, “An EBR solution is the GPS [global positioning system] of manufacturing operations. It guides the user to the desired destination, finds the shortest trip, alerts one to dangers, and feeds them back in real time.”

Quality assurance (QA) teams can use an EBR’s review-by-exception functionality to spot deviations much faster than scanning every record line by line to find them. This can speed up documentation review times and reduce how long a product must sit in a warehouse waiting for release. It also can improve batch accuracy and consistency.

Real-time information access also creates opportunities to speed up processes throughout the production cycle. For example, gauge data can be automatically collected versus requiring a worker to physically walk to each gauge and record their readings. The ability to collect and review process information also allows one to identify and eliminate unnecessary tasks, such as redundant material checks.

And the time savings only become greater in a connected enterprise. The ability to connect an EBR system to mobile devices, for example, can give workers faster and more convenient access to information anywhere on the plant floor.

Cut costs

Time-consuming compliance activities and human errors drive up production costs. But an MES with dynamic EBRs can help bring these costs down.

First, it can uncover new efficiencies to help optimize the total cost of production. The act of adopting EBRs for compliance purposes immediately eliminates the time and costs associated with storing physical documents. Dynamic EBRs can expand on those savings, by using automated QA functions to reduce the cost of researching process deviations, for example.

Second, an MES with EBRs can reduce the likelihood of human errors. The ability to create enforceable workflows, for example, helps ensure workers follow established processes and procedures, which can prevent production or recording errors that lead to wasted product or product recalls.

Finally, faster turnover helps reduce inventory costs. Specifically, the ability to automate processes and review exceptions as they happen, rather than after the fact, reduces how long a product must wait for release.

Drive compliance

Compliance is non-negotiable in biopharma, but there are ways you can minimize its burden. Integrating EBRs into an MES can allow automation of manual documentation processes to reduce the likelihood of errors, such as miscalculations and incorrect records. The ability to integrate recipe and order information in a connected enterprise can help get the right information to workers as efficiently as possible. Prevalidated recipe building blocks can be used to speed up deployment times. EBR features, such as role-based access, can help restrict production activities to authorized personnel.

Also, the same software used for MES and EBRs can serve as the core for a serialization system, aiding compliance with anti-counterfeiting regulations requiring product traceability and authentication and eliminating the hassle of creating, deploying, and managing a standalone pharma-serialization system.

Smooth integration

An MES combined with dynamic EBRs can have a substantial impact on operations, but the systems themselves do not need to be difficult and expensive to maintain or upgrade. An MES solution that aligns with industry standards, such as ISA88, will help simplify integration from the enterprise resource planning system down to the automation layer. An open-content architecture can give a highly configurable and easily upgradeable MES, allowing workers to make changes without impacting the system’s core.

Consider this full range of operations and integration benefits to realize the greater potential of an EBR system.

About the author

Martin Dittmer is product manager at Rockwell Automation