Computerized system validation is achieved by a framework of activities within the QMS rather than a single document set: governance, planning, risk management, specification and verification, supplier assessment, supporting processes, reporting and release, operational controls and retirement, each scaled to the system. The framework is applied through the company's policies and procedures, and the guide sets it out so that a plan describes and justifies the approach for a system and a report provides the evidence that the approach was followed and the system is fit for the use intended; for simple or low-risk systems the plan and report may be folded into other records, and for integrated equipment the framework is applied within the engineering process.
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.