ABSTRACT
Annex 11 requires that periodic evaluations or reviews be carried out throughout the operational phase of a computerized system’s life cycle to ensure that the system remains in a validated state.
This requirement needs to be combined with applying risk management principles from Annex 11 Clause 1.* Therefore, the frequency of the periodic review will be based upon the criticality of the computerized system: Critical systems will have more frequent periodic reviews compared with lower risk systems that will have longer intervals between reviews.
