ICH E6(R3) Annex 1 (Computer Systems Used in Clinical Trials) is the new section consolidating data integrity + electronic systems + computer system validation (CSV) - replacing scattered E6(R2) provisions. Scope: all computer systems used to collect + process + store + transmit clinical trial data and supporting documentation. Computer System Validation (CSV): GAMP 5 (Good Automated Manufacturing Practice) risk-based approach + USP/IPEC validation strategy + ICH Q9 quality risk management; fit-for-purpose validation; lifecycle (planning + URS + functional spec + design + implementation + testing + IQ/OQ/PQ + release + change control + retirement); risk-based scope (system criticality + complexity + customisation). Electronic Signatures (eSig): unique + biometric or PIN + timestamp + meaning of signature + audit trail of signatures + 21 CFR Part 11 + EU CTR + ICH E6 Annex 1; user authentication + identity proofing + workflow approval. Audit Trail: complete + contemporaneous + attributable + chronological + tamper-evident + protected + retained per study lifecycle; review process; audit trail report capability. ALCOA+ Data Integrity (Attributable + Legible + Contemporaneous + Original + Accurate + Complete + Consistent + Enduring + Available) per FDA 21 CFR Part 11 + EU CTR + EMA GxP Data Integrity Guidance + MHRA GxP Data Integrity + WHO Annex 5 Guideline on Data Integrity. Data Migration: from legacy + acquired system + EHR; validation + verification + data integrity preservation. Access Control: role-based + segregation of duties + periodic review + offboarding. Coordinates with 21 CFR Part 11 + GAMP 5 + ISPE + IPEC + WHO + EU CTR + JPMA + MHRA + PIC/S Annex 11. ICH E6 + Annex 1 + CSV + eSig + Audit Trail + ALCOA+ applies.
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