Annex 11 to EU GMP - Computerised Systems
Project Phase

Annex 11 to EU GMP - Computerised Systems Clause 4: Validation

Computerised systems must be validated throughout their lifecycle with documented protocols and user requirement specifications.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

What else in your programme already covers this

This control maps to 3 controls across 3 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

FDA 21 CFR Part 11 · 1 control

  • Part11.CSV Computer system validation + risk-based approach (21 CFR §11.10(a) + 2003 FDA Scope and Application Guidance + 2023 CSA draft)

GAMP 5 - Good Automated Manufacturing Practice · 1 control

  • GAMP5-Software-Categories 5 Software Categories (Appendix M4) - Infrastructure, Non-Configured, Configured, Custom

ISO/IEC 17025:2017 - General Requirements for Testing and Calibration · 1 control

  • 7.2.2 Validation of methods

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Query this from an agent

The graph holds this control, the 3 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpointAll Annex 11 to EU GMP - Computerised Systems controls