Grundlagen des Risikomanagements zur Validierung IT-gestützter Systeme Dr.-Ing. Günter Generlich Freiburg im Breisgau Korrespondenz: Dr.-Ing. Günter Generlich, In den Weihermatten 8, 79108 Freiburg im Breisgau (Germany),
e-mail: guenter@generlich.de Basics of Risk Management for the Validation of IT-supported Systems
Those who have to deal with the validation of IT-supported systems quite often do not have detailed knowledge or experience in computerised systems validation.
Risk management is then highly recommended. This overview article at first presents typical conditions for the risks during systems validation within pharmaceutical environments. Additional sections introduce the most important elements, structures, and methodologies of a risk management, which both complies regulatory requirements and allows executing validation tasks more efficiently, cost-effectively and professionally. Key words Computer-Validierung • IT-gestützte Systeme • Risiko-Analyse • Risiko-Management • Validierung | 
