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

Annex 11 to EU GMP - Computerised Systems Clause 9: Audit trails

Time-stamped audit trail records of all GMP-relevant changes and deletions must be maintained with documented reasons.

Other controls in Operational Phase - Data Management

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The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.