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
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AI-assisted GxP validation documentation: what exists
Yes — AI-assisted tools now exist that draft GxP validation documentation: user requirements, functional specifications, risk assessments, test protocols and traceability matrices. Under GMP they share one hard constraint: the output is a draft until a qualified human reviews it, and the Quality Unit — not the tool — approves the final document.