Electronic Batch Record Design

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 of making no changes to the original process or the paper based batch record recording requirements. The resulting implementation had only partially archived the projects objectives. The over all efficiency in both the batch record documentation process and operational improvements was below expectation.

The client had discovered that sufficient planning time had not been dedicated to the original MES implementation design. A 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%.

Endeavor was retained to provide 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 and the goal of reducing the review process by 50%. Key aspects of the design included creating an automated data retrieval capability for process variable and restructuring the batch record to eliminate redundant operator entries.

Upon acceptance and implementation of the new process, supported by new capabilities in the MES system the 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%.