A Periodic Review is essential to ensure the validated state of an automation system. In general a periodic review is scheduled every two years.
Subjects for review are:
- Documentation (complete, correct, up to date)
- Change of use
- Level and nature of changes
- Outstanding actions
- Previous reviews, reports, audits
- Prove of unstable or unreliable operation
- Changes in circumstances
- Regulations, environment, product, business, best practices, personnel
- Procedures, incident logs
- Software and data backups
A Periodic Review may be part of an internal audit. The results of the Periodic Review can be used for external audits.