CSV practice — how the documentation gets made

This is the working end of computer system validation: the chain from user requirements through risk assessment and testing to a validation report, and how much effort each step deserves. GAMP 5 (2nd Edition, 2022) makes that scaling explicit. Posts here cover the practice, including AI-assisted drafting — where AI never approves anything. ISPE GAMP 5 (2nd Edition, July 2022), risk-based approach and critical thinking