Maintaining Validated State: Periodic Reviews & Change Management in CSV Maintaining the Validated State in Pharma: How to Manage Periodic Reviews, Change Control, and Compliance Validating a computerized system is only half the battle in the pharmaceutical lifecycle. The real challenge lies in maintaining that validated state throughout the system’s operational life. Regulatory bodies like the FDA, EMA, and WHO expect pharmaceutical companies to ensure their GxP systems remain compliant, effective, and under control — even years after the initial validation. This article outlines a robust strategy for maintaining the validated state of computerized systems, with emphasis on periodic reviews,…