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Writing on computer system validation in regulated manufacturing: GAMP 5, Annex 11, draft Annex 22 and 21 CFR Part 11.
Accurate and complete copies: §11.10(b) in practice
21 CFR §11.10(b) requires the ability to generate accurate and complete copies of electronic records, in both human-readable and electronic form, suitable for inspection, review and copying by the agency. The copy must preserve the record's content and meaning — which is exactly where flattened exports of dynamic records usually fail.
Authority checks under Part 11: §11.10(g) in practice
Authority checks under 21 CFR §11.10(g) ensure that only authorized individuals can use the system, electronically sign a record, access input or output devices, alter a record, or perform the operation at hand. In practice they are role-based permissions with evidence behind them: a permissions matrix, periodic access reviews, and records of changes to access.
Closed vs. open systems under 21 CFR Part 11
Under 21 CFR Part 11 the distinction is who controls access: a closed system is one where system access is controlled by the people responsible for the content of the electronic records; an open system is one where it is not. Closed systems follow the §11.10 controls; open systems add measures such as encryption under §11.30.
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.
Annex 22 and AI in validation documentation
The draft of EU GMP Annex 22, published for consultation in July 2025 and not yet binding, expects AI in GMP to have a defined intended use, validation and change control, human oversight of outputs, and data transparency. For documentation this means output stays a draft until a qualified person reviews it, and the review is recorded.