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.
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.
We are aligning GAMP® principles with industry best practices, providing case studies and guidance.
The group includes life sciences companies, consulting organizations, and industry suppliers, including Microsoft and Amazon Web Services, with regulators across the world participating.
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.
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.
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.
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.
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.
Lorrie Vuolo-Schuessler has been involved with ISPE and GAMP® projects since 2002. She has authored or co-led 11 ISPE GAMP-focused guidance documents, including ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) and the ISPE GAMP® Good Practice Guide: Enabling Innovation - Critical Thinking, Agile, IT Service Management. She is Immediate Past Chair of...
An ISPE member since 1999, Charlie Wakeham has been active within the ISPE GAMP® community since 2001. A founding member of the GAMP UK Community of Practice (CoP), she is currently Chair of the GAMP Global CoP Steering Committee, one of the leaders of the GAMP Computer Software Assurance Special Interest Group (SIG), and a member of the ISPE Guidance Documents Committee. She has co-led or...
Pharmaceutical Engineering® magazine is proud to announce that the 2022 Roger F. Sherwood Article of the Year is “Supporting Cell and Gene Therapy through...