Annex 11 to EU GMP - Computerised Systems
General Requirements (Annex 11)

Annex 11 to EU GMP - Computerised Systems Clause 1: Risk management

Risk assessment should be performed throughout the lifecycle to determine the level of validation and data integrity controls.

Other controls in General Requirements (Annex 11)

Query this from an agent

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