GMP GUIDES BY PROFESSIONAL AREA

Computer System Validation (CSV)

The Computer System Validation (CSV) Collection brings together operational guides and practical tools to validate computerized systems in a GxP environment (CSV/CSA, GAMP 5, Annex 11, 21 CFR Part 11), supporting QA, IT, and Validation teams in ensuring regulatory compliance, data integrity, and audit readiness throughout the entire system lifecycle.
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  • Immediate digital access
  • Operational tools
  • Built for audits and inspections
THE OPERATIONAL PATH From responsibility to evidence.
  1. 01 RequirementSources, standards and expectations
  2. 02 DecisionClear, risk-based criteria
  3. 03 ActionGuides, SOPs and templates
  4. 04 EvidenceSolid, audit-ready outputs
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