Computer system validation blog · Valready Writing on computer system validation in regulated manufacturing: GAMP 5, Annex 11, draft Annex 22 and 21 CFR Part 11. https://www.valready.com/en/blog/ 2026-09-02T00:00:00Z Valready Accurate and complete copies: §11.10(b) in practice https://www.valready.com/en/blog/part-11-accurate-complete-copies/ 2026-09-01T00:00:00Z 2026-09-01T00:00:00Z 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 https://www.valready.com/en/blog/part-11-authority-checks/ 2026-09-01T00:00:00Z 2026-09-01T00:00:00Z 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 https://www.valready.com/en/blog/part-11-closed-vs-open-systems/ 2026-09-01T00:00:00Z 2026-09-01T00:00:00Z 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 https://www.valready.com/en/blog/ai-assisted-gxp-validation-documentation/ 2026-08-31T00:00:00Z 2026-09-02T00:00:00Z 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 https://www.valready.com/en/blog/annex-22-validation-documentation-ai/ 2026-08-31T00:00:00Z 2026-09-02T00:00:00Z 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.