Journal of Clinical Trials
Open Access

Abstract

The 7th System: Integrating Clinical Systems into a Comprehensive Quality Audit Program

Brett Vengroff

Clinical quality systems are often managed independently of manufacturing and laboratory operations. This can result in a fractured view of each compliance area (GCP, GMP and GLP) and a failure to provide adequate oversight of an organization’s overall compliance. Using FDA’s six-system inspection model as a starting point, this article will discuss how to integrate the requirements of clinical quality systems with a GMP compliant quality program to provide a system for comprehensive quality oversight.