Guide · 12 min · 2026-08-25

WHO GMP & Prequalification Software Validation Guide: Computerized Systems Compliance for Global Export Pharma

Comprehensive compliance roadmap for WHO Good Manufacturing Practices (TRS 961 Annex 2) and Prequalification: computerized system validation, ALCOA+ data integrity, and multi-market audit readiness.

1. WHO TRS 961 Annex 2 Standards for Computerized Systems

Manufacturers supplying essential medicines, vaccines, and APIs under WHO Prequalification programs must satisfy rigorous data integrity principles: • Uncompromised Audit Trails: Independent chronological logs of all create, modify, and delete transactions with system timestamps. • Access Control & Segregation of Duties: Strict role-based permissions preventing operators from altering system clocks or configuration files. • Complete GAMP 5 Validation Documentation: Traceability matrix mapping user requirements (URS) to IQ, OQ, and PQ validation test scripts.

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