As part of the validation lifecycle for qualified equipment and systems, a Periodic Validation Review is done to ensure that all critical requirements in the original qualification are met, to ensure that the qualification meets current standards, and to ensure that the equipment/system remains in a controlled state.

A PVR Schedule is created for all qualified equipment and systems. Once the equipment or system is qualified and the commissioning process has been completed, this gets added to the PVR schedule in a controlled document (either a Validation Master Plan or governing SOP/BOP) with a set due date. The PVR must be completed by its due date, usually either 1 year or 5 years after the initial qualification (upon closure of IOQ or PQ) depending on level of risk or criticality of the equipment.

Author: Gianna Hay, Senior Project Engineer