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Electronic Batch Records

Glossary

Electronic Batch Records (EBRs) are a form of digitized compliance. They help to reduce errors, streamline traceability, and generate a high volume of documents in the Life Sciences space. 

 

 

What Are Electronic Batch Records

 

EBR solutions are designed to track everything associated with a batch manufacturing process. As more and more Life Sciences companies undergo digital transformation, many manufacturers are relying on EBR to track their batch production data.

So what, exactly, are Electronic Batch Records? These records capture all the relevant information entered electronically or manually in digital form. The idea here is to prove that an organization is properly documenting the critical steps involved in producing batches of a product. EBR solutions include all data involving:

 

  • Operators
  • Manufacturing
  • Equipment, materials, and supplies

 

An EBR solution can help Life Sciences organizations ensure compliance with 21 Code of Federal Regulations (CFR) Part 11, which offers guidance on how the Food & Drug Administration (FDA) accepts electronic records and electronic signatures.

 

 

Why EBR Matters

 

As we mentioned above, Life Sciences companies have long relied on batch manufacturing processes to produce their products. These processes promote quality control and can be seamlessly tailored to the manufacturer’s needs. The records of these batch processes keep everything well-organized and documented.

Electronic Batch Records are even more effective at reducing human error, improving compliance, and establishing higher operational efficiency. They also promote conformity with standardized process controls, increase the visibility of manufacturing processes, and elevate throughout and production quality.

Clearly, digitizing your batch records can bring expansive benefits. Better resource management and inventory management, along with fewer material losses, are just the beginning. In terms of their bottom line, organizations will almost certainly benefit.

But what should organizations consider at the very beginning stages of implementing an Electronic Batch Records solution? There are three key factors to keep in mind:



1. Culture 


When transitioning to an Electronic Batch Records solution, organizations must first and foremost evaluate and strengthen their culture. Examining how people work with one another, how they use data, and how they implement processes are all vital considerations. 

Team members in different roles, from operations to engineering, must be trained in the right activities—and able to access the data they need at the right time. Yet cultural changes must take place before this training can begin. Organizational leaders must communicate their desired direction to the entire company, describing why it matters and what it will take to get there.

This same cultural shift must be communicated from the top down. While management should spearhead these conversations, the entire organization must accept the evolution taking place—and communicate any concerns or ideas they may have. Alignment, consensus, and teamwork are truly vital, so management should make certain to encourage an open dialogue.

 

2. Tech

An EBR solution is meant to provide an integrated work environment, pulling information from a full range of control systems. To prepare, various technology solutions should be assessed based on the situation at hand. Generally, different scenarios will have different operating needs.

To this end, guidelines should be written on how to apply and integrate the new technologies the EBR solution requires. While a process with extensive manual steps won’t need much automation—instructions to the operator are more important in this situation—common steps should still be evaluated to promote consistency in the EBR workflow.

Automated processes, meanwhile, require the same level of consistency (though they are often more flexible). Any technology solution your organization considers should be able to confirm that the relevant data aligns with ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate) principles. Investing in systems that send data digitally to the EBR solution will reduce the need for manual data entry and verification, making the right tech all the more essential. 

 

3. Processes

To ensure data integrity in the EBR workflow, teams must follow a consistent set of organizational procedures. Your Life Sciences company will need to prevent data from being manipulated by creating a data-integrity strategy for processes such as equipment management, material management, and batch record process flow management.

Exception management is a priority as well. In this case, all production information must be available in the batch record—including deviations that could impact product quality. The EBR can then create an exception-based report, offering a much easier review as a result.

Finally, topics such as user and workstation management, electronic signatures, and disaster recovery should be consistent across the organization. A disaster recovery plan is paramount and must be tested for sufficient data backup and recovery.

A reminder that throughout, the integration of an EBR workflow should meet your enterprise’s exact business needs. It’s important to find the Electronic Batch Records solution that’s right for you.

 

 

 

Conclusion

 

While investing in an Electronic Batch Records solution is no simple feat, the risk of not turning to an EBR workflow is far greater than that of implementing one. Not implementing an EBR solution, in fact, can result in rising business costs, product quality problems, and compliance issues that could have otherwise been avoided. Plus, without an Electronic Batch Records solution, organizations must pay for manual tracing, compliance, and information gathering. Not very appealing, right?

In short, the future of Life Sciences manufacturing lies in digital solutions—and Electronic Batch Records are no exception. As teams increasingly turn to apps to perform their job tasks, data from each procedure is collected automatically more often than not, making EBR a seamless way to ensure compliance. Investing in the right solution will allow your Life Sciences company to spend more time developing a high-quality product and less time identifying and rectifying costly errors.



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