Roles and responsibilities for computerized systems are clearly defined and communicated, including those of the process, system and data owners, the quality unit, subject matter experts, suppliers and end users, together with who approves what and what each approval means, so that accountability for compliance and for fitness for intended use is unambiguous. Delegation is allowed provided it is defined and documented, and where suppliers or service providers perform activities the responsibilities are set out in agreements while regulatory accountability stays with the regulated company.
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.