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

Annex 11 to EU GMP - Computerised Systems Clause 7: Data storage

Data must be protected through physical and electronic means with regular accessibility, readability and accuracy checks.

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

GAMP 5 - Good Automated Manufacturing Practice · 1 control

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

NIST SP 800-53 Rev 5 · 1 control

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 3 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpointAll Annex 11 to EU GMP - Computerised Systems controls