A new ISPE Special Interest Group (SIG) has been formed under GAMP® to address the increasing use of cloud services. A conversation with Michael Osburn, Head of Quality at Cornerstone OnDemand, and Judy Samardelis, IT Quality Director at Thermo Fisher Scientific, who are leading the new Special Interest Group, provides some details.
Why has this Special Interest Group been formed?
The industry is increasingly relying on cloud services to reduce IT footprints with on-premise data centers, while increasing storage capability requirements as manufacturing and R&D create vast amounts of data that cannot be stored on premise. The Special Interest Group was formed to create tools and guidance for use throughout the industry.
What are the key drivers/objectives of the Special Interest Group?
We are aligning GAMP® principles with industry best practices, providing case studies and guidance.
What regions are represented by Special Interest Group members?
The group includes life sciences companies, consulting organizations, and industry suppliers, including Microsoft and Amazon Web Services, with regulators across the world participating.
What are the hot topics being addressed?
One hot topic involves defining supplier quality agreements aligned with the recent GxP working group paper, “Application of SOC 2+ Process to Assessment of GxP Suppliers of Services,” published in Pharmaceutical Engineering (July–August 2019).
Another priority is to review the technical controls of the ISPE GAMP® Good Practice Guide IT Infrastructure Control and Compliance, 2nd edition, and align with industry best practices.
What are the main challenges with these topics?
The primary challenges are changing the current industry quality assessment practices and processes on how cloud services should be evaluated and maintained throughout their life cycles.
What is the expected output of the Special Interest Group, and what is the time frame?
Expected outputs include providing a case study on the evaluation of a SaaS provider and providing a quality agreement template for publication in Pharmaceutical Engineering for industry use.
Wider Distribution Opportunity for Some Pharmaceutical Engineering Articles
Pharmaceutical Engineering is piloting an open-access program to allow greater access to some of the great content published in the magazine. Several articles from each issue will be available for viewing by any visitors to the Pharmaceutical Engineering Online site. Most of the magazine will remain “locked” as an exclusive ISPE member benefit.
Opening access to some Pharmaceutical Engineering content offers authors the opportunity to indicate interest in having a wider distribution for their articles. Selections for open access are made by the Senior Director, Editorial, in consultation with the Pharmaceutical Engineering Committee as needed.
Please indicate in your submission if you would like us to consider your article for open access. While we cannot promise that every open access status request will be approved, we will consider author requests.
If you have questions about open access, please contact Susan Sandler, Senior Director, Editorial for Pharmaceutical Engineering magazine.
We’d like to feature your Chapter, Affiliate, Community of practice, or other ISPE group in upcoming ISPE Briefs.
Share highlights from training programs, conferences, social events, or other activities in an article of 250 to 400 words. We welcome photos (300 dpi or >1 MB). Send submissions to Susan Sandler, Senior Director, Editorial for Pharmaceutical Engineering magazine.
