Validation
15 min read
January 26, 2026
Computer System Validation - FDA 21 CFR Part 11 and EU Annex 11
Dr Anna Kowalska
Quality & Compliance Director
Key Takeaways (TL;DR)
Executive Summary
Validation must be risk-based (GAMP 5)
Key elements: IQ, OQ, PQ, and requirements documentation
Electronic signatures require unique user identification
Computer System Validation (CSV) is mandatory for all GxP systems in life sciences. FDA 21 CFR Part 11 and EU Annex 11 define requirements for electronic records and signatures. The modern GAMP 5-based approach focuses on risk analysis.
Frequently Asked Questions (FAQ)
What is GAMP 5?
GAMP 5 (Good Automated Manufacturing Practice) is an ISPE guide for computer system validation, promoting risk-based approach and software categorization.
Do SaaS systems require validation?
Yes, cloud systems (SaaS) used in GxP processes require validation. Responsibility is shared between supplier (infrastructure qualification) and user (configuration and process validation).
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