Computerized Systems Validation in the Pharmaceutical Industry
Kashif Hussain (University of Valenciennes, France), Shazia Yasin Mughal (University of Valenciennes, France) and Sylvie Leleu-Merviel (University of Valenciennes, France)
Copyright: © 2006
This chapter has reviewed the regulatory requirements definitions of FDA, AFSSAPS, EC and how computer systems can be validated with a relevant approach. By directing validation activities into a clear action plan, first, we need to analyze the specific organizational need according to the priorities and impacts to construct the required validation plan which can fulfill the requirements. The aim of the authors is to focus on a general approach to validation that can support several needs without addressing the technical aspects.