System Configuration Management and Version Control in an FDA Regulated Environment

Overview:

Managing the genealogy of database configuration and its life cycle is critical to following 21 CFR Part 11. In addition to recipes and equipment model configurations, phase logic and control strategies residing in automated control systems are an integral part of automated batch execution. Typical configuration management systems do not provide the capability to implement and guarantee a standard development procedure for the database configuration. With a set of enforced qualification states and GAMPbased transitions, a strategy that has been properly tested and approved with signatures can be installed on a process system. For control systems operating in validated environments, this procedure is paramount. This paper explores the life cycle management requirements for batch phase logic and control strategies executing in a validated environment.