The impact of new regulations on computerized systems in a GCP regulated environment

Abstract

Approaches to computer system validation have changed considerably over the past few years. Rules and guidance documents are now focusing mainly on electronic records management, transmission and maintenance (with emphasis on data integrity and security). Strategies for the implementation and validation of computerized systems need to consider the opportunity to use tools such as process mapping and risk analysis to support the validation effort. In particular, process mapping is useful during the user requirement definition phase, while risk analysis has became a key tool when defining the scope of computer system validation. These considerations can extend to the e-CRF system used for collecting clinical trial data through the web. Copyright © 2004 John Wiley & Sons, Ltd.