Quality risk management for computerized systems follows a framework consistent with ICH Q9: risks to patients, product quality and the integrity of data are identified, assessed, controlled, communicated and reviewed, with effort, formality and documentation matched to the level of risk. Risk management is used both to remove or reduce identified risks to an acceptable level and to decide which life cycle activities a specific system needs, and it is applied throughout the life cycle, from the initial GxP determination and impact assessment through functional risk assessment, test planning, operational controls, change management and retirement.
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.
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.
The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.