A Compliance Management System for the Pharmaceutical Industry

The management of compliance with rules, policies, guidelines, practices, and standards is largely done through a manual and labour-intensive process. This process can be facilitated through the use of a computer-based Compliance Management System (CMS). A CMS identifies compliance tasks, tracks the performance of these tasks with respect to a set of requirements and documents their compliance status. The output from a CMS can be used to satisfy a variety of reporting requirements and initiate alerting mechanisms. A CMS can be particularly useful in managing regulation change and overlap. This paper presents the first step in the development of a decision and compliance management tool, in particular, a prototype CMS for the pharmaceutical industry is described. The CMS has been tested with a simulated case study.