Computer System Validation – Application of the Validation Plan

Regulations set forth by the FDA establish an expectation that all aspects of a regulated manufacturing process are well-established, documented, and controlled to ensure consistent high-quality products. The Validation Master Plan (VMP) is critical in achieving this goal by documenting compliance requirements and explaining necessary validation activities across a manufacturing operation. Unlike a written plan for a specific validation project, the VMP functions at the top layer control, establishing a defined approach to all validation activities and describing the risk-based strategy for achieving and maintaining a fully-qualified facility supported by all necessity validated processes. The MVP provides an umbrella approach, but the individual plans provide detail specific to the application.