24-26 April 2024
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:
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.
Substantial guidance for evaluating a CSP from an authority perspective is provided by EFG 11's Votum V1100202 "Anforderungen an die Aufbewahrung elektronischer Daten" (Electronic Data Retention Requirements; Document is only available in German
According to Votum V1100202, the requirements for qualifying the IT infrastructure (IAAS, PAAS), validating the application (SAAS) and ensuring availability, readability and integrity must be fulfilled by an (internal or external) service provider. Crucial is the indication that a risk to patients and/or the quality of the drug product is to be eliminated. According to the Votum, an assessment should include the following points in particular:
Find more Q&As on the topic "Cloud Computing" which have been answered by the expert team.
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