Operational System Checks — §11.10(f)

Operational System Checks. The system shall employ operational system checks to enforce permitted sequencing of steps and events, as appropriate, in accordance with §11.10(f). Operational system checks are programmatic controls built into the system to ensure that processes are executed in the correct order and that required steps are not inadvertently or deliberately skipped. The following operational checks shall be implemented where applicable: (a) workflow enforcement mechanisms that ensure required process steps are completed in the prescribed sequence (e.g., a batch record cannot advance to the next production step until the current step has been completed and electronically signed); (b) system controls that prevent the entry of data outside of predefined ranges, formats, or value sets (e.g., input validation, field format checks, and reasonableness checks); (c) system controls that prevent the approval of records by the same individual who created or modified them, enforcing separation of duties where required by applicable predicate rules; (d) system controls that require the completion of all mandatory fields before a record can be saved or submitted; (e) system controls that enforce the completion of prerequisite activities before subsequent activities are initiated (e.g., equipment calibration must be current before use in testing); and (f) all operational system checks shall be documented in the system design specifications and verified during system validation (OQ/PQ).