This chapter looks at the last step in the validation
process, reviewing periodically.
When a system is certified, the control procedures
should ensure that it continues to operate as validated. However, small
changes over time can cumulatively affect the performance of a system.
The system should therefore be reviewed periodically to
provide additional assurance of validation. The interval between reviews
will depend on the level of use of the system and its criticality - critical
systems will probably be reviewed annually.
It is the responsibility of the user/system/application
owner to ensure that the periodic review is performed on the
The management of the periodic review requirements for
all systems will be achieved through the site/departmental Validation Master