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

Annex 11 to EU GMP - Computerised Systems Clause 17: Archiving

Periodic checks for accessibility, readability and integrity of archived data with retrieval capability after system changes.

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

What else in your programme already covers this

This control maps to 2 controls across 2 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

GAMP 5 - Good Automated Manufacturing Practice · 1 control

  • GAMP5-Supplier-Operations-Change-Periodic Supplier Assessment, Operational Phase, Change Control and Periodic Review

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

Query this from an agent

The graph holds this control, the 2 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpointAll Annex 11 to EU GMP - Computerised Systems controls