Case Study 12: Electronic Document Management Systems

INTRODUCTION Document management covers the preparation, review, approval, issue, change, withdrawal and storage of documents. Good practice (GxP)—for example, as described in GAMP15 Appendix M9 (1)—must be applied consistently throughout the full document life cycle for a regulated organization to be able to demonstrate the level of control now demanded by regulatory bodies. Electronic document management systems (EDMS) are a class of applications specifically developed to support these requirements. This paper describes an approach to successful implementation of such systems.