The PhUSE Framework for the Adoption of Cloud Technology in the Regulated Life Sciences Industry: Within the PhUSE Computational Science Collaboration (a collaborative initiative including PhUSE, pharma, standards-developing organizations and regulatory agencies), the Emerging Trends and Technologies Working Group has formulated a framework to enable life sciences organisations to address and overcome real or perceived barriers to the adoption of cloud-based technology solutions in the GxP-regulated spaces.
This framework outlines approaches for our industry that leverage existing ISO and NIST standards and, above all, illustrates the multiple operational models that are a) possible, b) practical, c) beneficial, and d) compliant with appropriate regulatory predicate rules and security standards. Our discussions provide a brief outline of the framework and an opportunity to get the panelists’ views on particular thoughts and challenges for yourselves and/or within your organisations.
Anders Vidstrup, NNIT A/S
Chris Whalley, Amazon Web Services
Suzanne Studinger, Quality Assurance Studinger
Bill Telford, Sanofi
Dan Dziadiw, Merck
Tony Hewer, Medidata Solutions