COMPLIANCE REVIEWS

ViP Definition
"A Compliance Review provides documented evidence to demonstrate that all key aspects of a proposed design package comply with the applicable user, process, current GXP and GEP requirements."

A Compliance Review is a documented assessment of the compliance of a design package with all applicable user, process, current GXP and GEP requirements.

A Compliance Review performs the same function as the Enhanced Design Review advocated by the ISPE in its Baseline Guide on Commissioning and Qualification, and what some refer to as Design Qualification (DQ).  Enquiries are issued to prospective vendors and the proposed designs submitted are checked for compliance with the URS.