Annex 11 to EU GMP - Computerised Systems
Operational Phase - Data Management

Annex 11 to EU GMP - Computerised Systems Clause 6: Accuracy checks

Critical manually entered data requires verification by a second operator or validated electronic means.

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 - Data Management

Query this from an agent

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