Electronic Batch Records (EBRs) occupy a unique position in the complex world of pharmaceutical manufacturing, bridging the realms of Manufacturing Execution Systems (MES) and quality management and compliance systems. Traditionally viewed as records of production activities, EBRs have evolved into much more than mere documentation. They embody instructions, standard operating procedures (SOPs), recipes, and records, all intertwined into a comprehensive system. However, the term “Electronic Batch Record” fails to capture these systems’ true essence and functionality.
In this blog, we delve into the multifaceted nature of EBRs, their pivotal role in managing and tracking intricate processes, and the critical need for seamless integration with a company’s quality management system (QMS). We’ll also explore how EBRs assume a detective-like role, assisting in investigations, deviations, corrective actions, and change controls, ultimately enhancing overall product quality. Join us on this journey as we unravel the true potential of EBRs and their integration with QMS in modern pharmaceutical manufacturing.
EBRs Support Tracking Production and Managing Quality
At pharma companies, Electronic Batch Records (EBRs) sit at an interesting juncture between two major software domains. On the one hand, they are a critical component of the Manufacturing Execution System (MES). That’s because batch records are central to managing and tracking production activities during the manufacturing process.
On the other hand, EBR systems are an essential part of a quality management and compliance system. And that’s because they are the actual records of quality steps and processes required by regulatory authorities.
This is just one of the ways that EBRs are part one thing and part another. Another is that an EBR is part instruction, part SOP, part recipe, and part record, all simultaneously. That’s one of the reasons an effective EBR management system needs to be integrated with other systems, particularly the company’s quality management system (QMS).
That makes sense for a system with the word ‘record’ in it. In general, keeping accurate records is a crucial function of any QMS. But here again, thinking of an EBR primarily as a record is an oversimplification.
In fact, “Electronic Batch Record” is a misleading name. In reality, EBR solutions are about managing and tracking complex processes as much as they are about record keeping.
Defining the Meaning of Modern Batch Records
The term Batch Records comes down to us in the same way your family name comes down to you. Just because your name is Johnson does not, in fact, mean that you are the son of John, but it is the name you inherited. And it is much the same with the term ‘Electronic Batch Records’ – we inherited it, but it does not describe what an EBR is or does very well.
The term ‘Batch Record’ makes sense when referring to a paper-based document with notes and annotations about the batch of product being produced. In that model, the document is the actual production record of the batch. A modern EBR system, however, sits at the nexus of several processes and performs functions well beyond record-keeping.
Perhaps we should call them Batch Management Systems – it would be more accurate. That’s because the functions and roles of an EBR solution include acting as an instruction set, a process manager, a collector and aggregator of information, and an alarm system.
Playing Detective with EBRs
An electronic batch records system is also a part-time detective. So maybe an even better name would be Watson, as in Sherlock Holme’s partner in crime detection.
The detective role of an EBR solution relates to its role in an investigation that results FROM deviations and (hopefully) results IN Corrective Actions and Change Controls. And to play that role effectively, any EBR solution should be integrated effectively into the organization’s quality management system (QMS), where Deviations, CAPAs, and related processes are managed.
Let’s talk about that integration. A modern EBR system should allow you to configure expected test results, expected timeframes, and expected actions. When any of those things do not occur, the system should be able to inform the QMS that a deviation has occurred.
And not just that a deviation has occurred; but when it occurred, where in the process it occurred, and what the operative conditions were when it occurred. That’s where the detective analogy comes from because the EBR supplies many clues to inform the investigation. By providing information about the state of the production environment when a deviation occurs, the EBR system, like Watson, aids and abets the discovery process.
Information between the QMS and the EBR system also works in the other direction. The QMS needs to be able to, through a workflow, deliver a corrective action, new procedure, or other instructions to the master batch record (the template from which each batch record is derived). And that completes the loop: An out-of-specification incident occurs, a deviation is initiated, an investigation is executed, corrective action is issued, and a new process is put in place for future batches.
Of course, there are many other ways that QMS and EBR solutions should be integrated. For example, a shared login is ideal, and it would be good if the two systems shared a look and feel and navigation scheme. But frankly, all that is nice to have, while the ability for the QMS and the EBR to pass information back and forth as part of the fundamental quality workflow process is a “must-have.” It pays big dividends in time saved and improvements in quality and should be a central requirement for every EBR implementation.
Get EBRs Working for You
Electronic Batch Records encompass a comprehensive set of functions that extend far beyond record-keeping. Integration with a robust quality management system (QMS) is essential for efficient deviation management, investigations, and corrective actions. By harnessing the power of EBRs and QMS integration, pharmaceutical companies can streamline processes, improve product quality, and drive continuous improvement in their manufacturing operations.
You can learn more about electronic batch records by watching our recent webinar on-demand or requesting a demo of Scigeniq’s EBR solution.