Configuration Management can be defined as the detailed identification of a total system available at any time in the lifecycle of the project to which it is applied, including the traceability of all changes and enhancements made throughout the lifecycle of that project and its associated computerized systems.

According to the FDA General Principles of Software Validation, "a configuration plan should be developed that will guide and control multiple parallel development activities and ensure proper communication and documentation."

Computerized system validation is impossible without configuration management. The Configuration Management Validation Master Plan will ensure compliance with FDA regulations.