Guidance and reference material on computerized system validation and the regulations that shape it.
Written for the QA, IT, and validation teams we work with every day.
Reference guide
Regulations & Standards
A plain-English map of the rules governing computerized systems in pharma — 21 CFR Part 11, EU GMP Annex 11, GAMP 5, the FDA’s 2025 Computer Software Assurance (CSA) guidance, and ALCOA+ data integrity.
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Article
Achieving FDA 21 CFR Part 11 Compliance
What Part 11 actually requires — system access, audit trails, and electronic signatures — plus the six practical steps to reaching and sustaining compliance.
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Article
Complying with Computerized System Validation Requirements
A risk-based approach to CSV and the GAMP 5 deliverables — URS, IQ/OQ/PQ, traceability — that satisfy regulators without over-documenting.