Why Controlling Documents in Electronic Batch Records Matters
The quality of production operations in regulated industries can vary directly with the quality of the information in the Electronic Batch Record. Both the work completion and “review and release” activities demand exact, understandable, and complete EBR design to be successful.
At InstantGMP, we have covered key EBR design topics like configurability and workflow integration. Our overall architecture is based directly on CFR-stated EBR operational regulations, using capabilities like 21 CFR Part 11, not a repurposed EDMS lifecycle format. Additionally, our
Master Production Records allow documents (typically SOP’s, general instructions, etc.) to be attached in the MPR “Documents” section, with status visible immediately. All documents attached to an EBR are also shown in an EBR PDF summary file.
So why is it important to manage documents in Electronic Batch Record?
The following reasons demonstrate the importance of managing these documents:
- They help supply the most recent additions to the operational plan. Often, the revisions originate from deviation root causes, CAPAs, and other sources that recommend change from experience.
- They convey a sense of diligence and continuous improvement to any EBR reviewer, who, in our design, could be a partner or a customer as well as an internal quality or project manager.
- While not a substitute for all required changes, it’s easier in our design to identify and version the attached documents than it is to correct the Electronic Batch Record or the MPR.
The documents (and other file types) are created and versioned in our Electronic Document Management System (EDMS). Document operations can be done in-house or with secure external collaboration.
Our all-in-one PRO software system was built to enable document management and production to work together. Contact InstantGMP to see a live demo of how our PRO Software records and plans batch manufacturing easily.