Cloud Computing: Authorities' Expectations od Cloud Service Providers?

The trend in the pharmaceutical industry is also moving towards cloud computing. Financial but also organizational advantages speak for the cloud. At the same time, however, potential dangers and regulatory restrictions should also be taken into account. Nine experts from the pharmaceutical industry and regulatory authorities answer a comprehensive catalog of questions from the following GxP-relevant topics:

• Basics of Cloud Computing Technology
• Regulations and Expectations of Inspectors
• Customer-Supplier-Relationship
• Requirements for Cloud Service Providers (CSP)
• Requirements for Supplier Evaluation and Supplier Audits
• Requirements for Qualification / Validation

Question 29: Do the authorities accept that using cloud services entails a loss of control compared with on-premises operations? - Regulations and expectations of inspectors

In their GMP inspections, the health authorities take the position that the so-called 'regulated user' (employee of the pharmaceutical industry) must not have any loss of control when using a cloud service. This statement applies to all services offered by service providers (IaaS, PaaS, SaaS) that are used in place of an on-premise infrastructure/platform/application in the controlled area. SaaS is viewed particularly critical in this context, as GxP data is hosted by the service provider in validated applications.

Inspectors expect pharmaceutical companies to regularly check and audit their various service providers. It is often noticed that the service provider has commissioned further subcontractors to provide services, which must of course also meet the requirements of the regulated industry. Many SaaS providers use infrastructure services from Amazon Web Service (AWS), Microsoft (Azure) or Google, which do not usually allow audits.

Find more Q&As on the topic "Cloud Computing" which have been answered by the expert team.

The Experts

Frank Behnisch, CSL Behring GmbH, Marburg
Klaus Feuerhelm, Formerly Local GMP Inspectorate / Regierungspräsidium Tübingen
Oliver Herrmann; Q-FINITY Quality Management, Dillingen
Eberhard Kwiatkowski, PharmAdvantageIT GmbH, Neuschoo
Stefan Münch, Körber Pharma Consulting, Karlsruhe
Yves Samson, Kereon AG, Basel
Dr. Wolfgang Schumacher, Formerly F. Hoffmann-La Roche AG, Basel
Dr. Arno Terhechte, Local GMP Inspecorate / Bezirksregierung Münster
Sieghard Wagner, Chemgineering Germany GmbH, Stuttgart