Transcript
Do more than check validated
A periodic review should not end with a checkbox that says validated state maintained. Start with the approved intended use, owner, system and supplier version, configuration, interfaces, records, procedures, and prior validation conclusion. Then ask whether the assumptions supporting that conclusion remain true.
Use the operating record
Review accumulated changes, supplier releases, incidents, deviations, corrective actions, open commitments, user access, audit review where applicable, backup and restore, disaster recovery, service performance, new interfaces, new uses, and applicable regulatory or procedure changes.
Explain continued or conditional use
Conclude whether continued use is supported, conditional, restricted, requires revalidation, or should be retired. Identify evidence, limitations, accountable actions, target dates, monitoring, and the next review. A useful periodic review explains why the current system remains acceptable for its approved use.