A PEMS validation plan covers the validation of basic safety and essential performance and requires checks for unintended functioning; the methods are documented, validation is performed to the plan and its results documented; whoever is overall responsible for validation is independent of the design team, and why that degree of independence was chosen is recorded, no design team member validates their own design, all professional relationships between validation and design team members are documented in the risk management file, and a reference to the validation methods and results is included there.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.