Traditional Periodic Review vs. Continual Monitoring

There are two methods which can be followed for establishing and maintaining the validated state of a computer system. The first is the traditional periodic review of the computer system, which is performed at a predefined period. The second is continual monitoring and trending with a review report.

Equipment History or Validation Equipment Files can be used to provide continual monitoring of Incidents Logs, Deviations and Changes. By logging these either to paper or electronically can be used to trend. The continual monitoring can be used to make improvements before minor incidents become quality related deviations.

All actions and recommendations resulting from the Computer System Periodic Review should be logged in the company CAPA system.

Considerations

Consideration should be given to the number and extent of the changes and the impact of cumulative effect of the changes. Often verification is centered on the individual change. Reviewing the changes as a group can determine whether the overall design intent has been impacted.

Where risk assessments have been performed during the design and implementation of the system, the assumptions made at the time of the assessment (particularly frequency of occurrence) should be documented.

A report should be produced detailing the validation/compliance status of the system.