The regulated company establishes policies and procedures that set out how computerized systems are made, and kept, compliant and fit for the use intended, covering the life cycle approach, roles, planning, risk management, specification and verification, supplier management, operational processes and retirement, and it keeps them consistent with the QMS and with regulatory expectations. The procedures should permit and encourage critical thinking and scaling, so that templates act as prompts rather than mandatory forms, and they should be readily available to and followed by everyone with responsibilities for computerized systems.
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.