Privatsphäre-Einstellungen

Neue Bedeutung des Qualitäts-Risikomanagements

Anwendung eines risikobasierten Ansatzes in der Informationstechnologie

Dr. Jörg Schwamberger

Merck KGaA, Darmstadt

Consequent management of potential risks associated with the use of IT systems impacting product quality and/or patient/consumer safety is a fundamental requirement of regulatory authorities. Compliance with applicable GxP regulations requires an end-to-end risk management process minimizing potential risks at economically meaningful expenditure whilst fulfilling these legal requirements.
Based on current recommendations of authorities and industry, the following article describes the basic steps to apply a risk-based approach when designing and operating GxP-regulated IT systems.