Operation Phase

Audits and Review

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.