Monitor and control the validation process against the plan for performing the process and take appropriate corrective action.
Elaboration:
Examples of measures and work products used in monitoring and controlling include the following:
· Number of validation activities completed (planned versus actual)
· Validation problem report trends (e.g., number written and number closed)
· Validation problem report aging (i.e., how long each problem report has been open)
· Schedule for a specific validation activity