Open AccessThe impact of new regulations on computerized systems in a GCP regulated environment
Author(s) -
D'Incerti Gilda,
Valsecchi Giulia M.
Publication year - 2004
Publication title -
the quality assurance journal
Language(s) - English
Resource type - Journals
eISSN - 1099-1786
pISSN - 1087-8378
DOI - 10.1002/qaj.267
Subject(s) - scope (computer science) , computer science , process (computing) , key (lock) , data validation , software engineering , risk analysis (engineering) , systems engineering , process management , engineering , database , computer security , business , programming language , operating system
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 theô 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.