Annex 11 to EU GMP - Computerised Systems
Operational Phase - Security and Access

Annex 11 to EU GMP - Computerised Systems Clause 14: Electronic signatures

Electronic signatures must be equivalent to handwritten ones, permanently linked to records with date and time stamps.

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 1 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 · 3 controls

  • Part11.100 Electronic signatures - general requirements (21 CFR §11.100)
  • Part11.200 Electronic signature components and controls (21 CFR §11.200)
  • Part11.50_70 Signature manifestations + signature / record linking (21 CFR §§11.50 + 11.70)

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.

Other controls in Operational Phase - Security and Access

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

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