Cloud Computing: Relevance of SOC / SOC2 reports

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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

The following question is one of a series of questions that we will publish in further GMP News articles on this site in the coming weeks.

Question 13: A cloud service providers refers to SOC reports when assessed, especially to the SOC2 report. Would this report be sufficient as concerns the requirements of the assessment and could it be used? -  Customer-Supplier-Relationsship

The SOC2 report may be used for the issues we have in the GMP/GLP environment. But attention must be paid to the fact that the SOC2 report has to fulfil the requirements of the financial area. This does not cover the requirements of the pharmaceutical area. We've checked the change process in the SOC2 report for instance, and there remain some requirements not answered yet.

Conclusion: The SOC2 report is not sufficient for the assessment of a CSP.

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

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