13-15 December 2023
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.
According to the vote 1100202* the following applies:
Persons are to be included in the audit who are sufficiently experienced in this special technology. In principle, at least one person should come from IT. The lead auditor will normally come from quality assurance.
According to the vote the following topics should be addressed:
*Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten - Vote V1100202 of the group of experts 11 "Anforderungen an die Aufbewahrung elektronischer Daten" (Requirements for the storage of electronic data) - only available in German.
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