Cloud Computing: Open or Closed System according to 21 CFR Part 11?

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 24: If the pharmaceutical user has data in the cloud, what type of system is it? Is this an open or closed system according to 21 CFR Part 11? - Basics of Cloud Computing Technology

This is easy to answer using the definition below, even if it is an "on-premise" application: "It is an open system". The cloud provider carries out the compliance checks. The pharmaceutical company can only introduce the corresponding controls via contracts and check them via audits. Therefore, direct control is not possible!
Definition 21 CFR Part 11 § 11.3:

• (a) The definitions and interpretations of terms contained in section 201 of the act apply to those terms when used in this part.
• (b) The following definitions of terms also apply to this part:
   - (4) Closed system means an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.
  - (9) Open system means an environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system.

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