Einsatz von Cloud Computing im GxP-regulierten Umfeld
GMP / GLP / GCP
Abstract
Using Cloud Computing in the GxP-regulated Industry
Cloud computing is on everyone's lips and among experts is said to be a key technology for a new information processing age. Advantages like the worldwide availability of data and applications as well as cost savings due to the omission of company-owned IT infrastructure and expenditure-based accounting systems make its usage interesting even for the pharmaceutical industry. However, when used for GxP-relevant purposes also for cloud services there is an obligation of validation. Hereby specific efforts and risks are arising that have to be opposed to the benefit.
The article shows that cloud computing generally is not as new as frequently presented because it is based on IT concepts partly established since many years. Furthermore cloud computing does not necessarily mean public availability. There are service models that reduce the access to one or few companies. Aspects to be considered within the field of GxP are data integrity, quality management, qualification/validation and data privacy. According to these the article describes what has to be taken into account in detail and how the requirements have to be interpreted in the cloud environment. Depending on the applied cloud service model GxP issues have to be audited or the respective activities must be carried out by the regulated company itself. The responsibilty for validation finally remains with the user.
In summary, cloud services can also be used in the GxP-regulated industry. However, the benefit is in contrast to an increased management and auditing effort.
 | Dr. Ralf Weber studierte Medizinische Informatik an der Universität Heidelberg und an der Fachhochschule Heilbronn. Nach seiner Promotion im Bereich Softwareunterstützung klinischer Studien an der Universität Heidelberg war er drei Jahre IT-Leiter des Koordinierungszentrums für Klinische Studien des Universitätsklinikums Heidelberg. In dieser Funktion war er neben der Einführung und Weiterentwicklung von IT-Systemen zur Durchführung von klinischen Studien auch für deren GCP-konforme Validierung verantwortlich. Seit 2006 leitet er den Fachbereich IT-Validierung der gempex GmbH in Mannheim. Als Senior Consultant berät und |
