September 23, 2024

The Electronic Batch Record (EBR) in process and regulated businesses is a type of industry-adapted work order for production. It contains all the personnel, resources, testing, instructional, and approval information to support the end product created. An EBR system can help organize these records.

EBR’s may be simple mixing combinations or sophisticated operations with many resources, specifications, and rules in play. They may be specialized subroutines for other EBR’s to follow. For example, a formulation EBR might deliver bulk material to a packaging EBR. 

In the regulated domains, all activities must be documented with auditable approvals, etc. that ensure total traceability. Systems that produce EBR’s for pharmaceuticals, dietary supplements, etc. must follow the applicable guidelines cited within these links.

So what are the benefits that EBR’s can provide?

• A definitive snapshot of all the steps completed in creating a product 
• Automation to make the required entries accurate and efficient. These are electronic signatures, barcode/camera approvals, remote access by special permission for batch approvals, etc. 
• Captured data for analytics to improve processes using inquiries and query tools with completed EBR’s
• Connectability to other workflows, e.g., quality systems (EQMS) for expediting deviation management
• Adjustable worksteps for a set-up EBR. Qualified roles can adjust the EBR steps to minimize time consuming changes or revisions in the parent master production record (MPR)
• Predicate rule control for correct sequencing of operations and parallel processing when applicable to save production time

That’s the good news. However, EBR’s come with some built-in challenges.

• Volume of information to capture. EBR’s can have a LOT of moving parts and must be complete to support the product made.
• There are many systems that provide EBR’s. Those that are correct for regulated industries must have the capabilities and validation required from the Code of Federal Regulations (CFR’s). 

Based on these issues, selecting an EBR system that is right for your industry is not an easy task. 

We at InstantGMP built an entire suite of products around an EBR build-and-execute workflow based on the FDA regulations. That original design remains our platform. Many first-time viewers give it a “user benefit” rating, so it’s fair to say that our experience with this key operation is second to none. Here’s additional information about our approach to a configurable EBR system.

Seeking regulated EBR automation that is tried and true?  Contact us today!