Annex 11 to EU GMP - Computerised Systems
Operational Phase - Release and Continuity

Annex 11 to EU GMP - Computerised Systems Clause 15: Batch release

System access for batch release must be limited to Qualified Persons with required electronic signature identification.

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

What else in your programme already covers this

This control maps to 1 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 · 1 control

  • Part11.AccessAndAuth Access control + authority + device checks (21 CFR §11.10(d) + (f) + (g) + (h))

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 - Release and Continuity

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The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpointAll Annex 11 to EU GMP - Computerised Systems controls