Electronic Batch Record Design
Endeavor was retained to assist in the design of the new batch record system. Our primary tasks were to design a “to be” process that balanced three primary factors:
Limitations in changes to the batch record due to serious regulatory issues
Capabilities of the MES system
Reducing the review process by 50%
Key aspects of the design included creating an automated data retrieval capability for process variables, and restructuring the batch record to eliminate redundant operator entries.
Upon acceptance and implementation of Endeavor’s new process — supported by capabilities in the MES system — the client’s number of documentation errors was reduced by 70%. Batch record review times dropped by 70% for records with no errors, and investigations dropped by 40%.
A major device manufacturer had implemented a new MES system for a single process step in their production process. The project was constrained by a philosophy centered in keeping the original process and paper-based batch records the same.
The resulting implementation only partially archived the project's objectives — the overall efficiency in both the batch record documentation process and operational improvements was below expectation.
The client discovered that insufficient planning time had been dedicated to the original MES implementation design. A new project was developed to focus specifically on the Batch Record. The goal of the program was to reduce the batch record review time by 50%.