To be acceptable to users, a product or product component must perform as expected in its intended operational environment.
Validation activities are performed and the resulting data are collected according to the established methods, procedures, and criteria. The as-run validation procedures should be documented and the deviations occurring during the execution should be noted, as appropriate.
(For users of the continuous representation, this is a capability level 1 specific practice. Validation processes at capability level 1 or 2 may not include procedures and criteria, which are created in the Establish Validation Procedures and Criteria specific practice at capability level 3. When there are no procedures or criteria established, use the methods established by the Select Products for Validation specific practice to accomplish capability level 1 performance.)