The Complete Guide To Computer System Validation: IQ, OQ, And PQ

Computer system validation ensures FDA-regulated software performs accurately, securely, and reliably according to user requirements and 21 CFR Part 11 standards. The validation framework follows a three-phase protocol: Installation Qualification verifies proper system setup, Operational Qualification confirms functionality meets specifications, and Performance Qualification tests real-world user scenarios. Each phase builds evidence that the system operates as intended while maintaining data integrity, access controls, audit trails, and electronic signature compliance. The validation lifecycle doesn't end at implementation—system upgrades and new features require repeating the qualification process to maintain compliance.

Learn how to scope validation projects by identifying stakeholders, documenting requirements, and conducting risk analysis.