8-10 May 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 the first of a series of questions that we will publish in further GMP News articles on this site in the coming weeks.
IaaS, PaaS, and SaaS are abbreviations and different grades (or service models) of various cloud service provider (CSP) offerings. "aaS" always stands for "as a Service". In XaaS, the X is a placeholder for either I, P, or S, meaning Infrastructure, Platform, or Software. Sometimes, XaaS is also called "Anything as a Service" or "Everything as a Service" and can take very specific characteristics like "High Performance Computing as a Service (HPCaaS)" or "Artificial Intelligence as a Service (AIaaS)".
CSPs offer various services and benefits depending on the basic service model, and the tasks to be executed may shift accordingly (see Table 1):
In other words, the activities shift from user (regulated company as client) to cloud service provider (supplier). However, the responsibility for validation and operation of the application and all related topics like data integrity, data privacy, data security etc. remains with the regulated company.
Frank Behnisch, CSL Behring GmbH, Marburg
Klaus Feuerhelm, Formaly 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, Formely F. Hoffmann-La Roche AG, Basel
Dr. Arno Terhechte, Local GMP Inspecorate / Bezirksregierung Münster
Sieghard Wagner, Chemgineering Germany GmbH, Stuttgart