Apples and Oranges: Comparing Computer Systems Audits

Abstract

For a variety of reasons, comparing compliance audits from one vendor to the next is like comparing the proverbial apples and oranges. Each audit situation provides a unique set of issues, observations, and conditions. Yet, our readers (and occasionally our auditees) often request that such a comparison be performed. Do we simply count the total number of observations cited, multiplied by their severity, divided by the total number of documents reviewed? How do we compare? In this article, we investigate the possibility of comparing compliance audits of computerized systems used in the conduct of GxPs (ie, GCP, GLP, GMP). A model is proposed that provides the basis (foundation) and methodology for rating vendors of services (Contact Research Organizations) and products (software vendors).