The organization validates any production or service process whose output cannot be, or is not, verified by subsequent monitoring or measurement, so that deficiencies would only appear after the product is in use or the service delivered. Validation demonstrates the process can achieve planned results consistently. Documented validation procedures cover criteria for review and approval of the process, equipment qualification and personnel qualification, use of specific methods, procedures and acceptance criteria, statistical techniques with a sample-size rationale as appropriate, record requirements, revalidation including its criteria, and approval of process changes. Procedures are documented for validating computer software used in production and service provision before initial use and after changes, proportionate to the risk including the effect on product conformity. Records of results, conclusions and actions are maintained.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.