Validating a Clinical Data System: Technical, Organizational, and Managerial Aspects

After a brief introduction on the reasons for validating a clinical data system, this paper will provide a description of the organizational and technical environment in which validation at Organon International took place, followed by an overview of the actual audit that has been performed, and the project that was undertaken to arrive at a validated clinical data system. Organon's experiences and observations during these activities and plans for the future will be covered.