Martin Dittmer

	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.

	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.

	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.

	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.

	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.

	Martin Dittmer is product manager at Rockwell Automation 

Articles

Integrating EBRs with MES reduces time to market, cuts costs, and enhances compliance performance.

Using Electronic Batch Records to Their Full Potential

	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. 


	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.


	Martin Dittmer is PharmaSuite product manager, Rockwell Automation, 

Advanced electronic batch recording (EBR) manages workflows and recordkeeping for compliance and production efficiency.