Even in the Cloud, Life Science Companies Need the Optimal Balance Between Risk and Efficiency
Epista Life Science is proud to announce our citation as a sample vendor in two recent Gartner Hype Cycle Reports: Hype Cycle for Life Sciences, 2018(1) and Hype Cycle for Life Science Research and Development, 2018(2). In both reports, Gartner identified Epista as a Sample Vendor for compliant GxP Cloud Services. Epista was also cited in a 2017 report by Stephen Davies, Michael Shanler, Jeff Smith: Accelerate Digital Capabilities by Migrating Validated Life Sciences Applications to the Cloud (3). Klavs Esbjerg, CEO of Epista, states: “We feel this reaffirms our commitment to our mission to continuously improve regulatory compliance – both for our clients and for the industry as a whole.”
According to both the Hype Cycle for Life Sciences, 2018 and the Hype Cycle for Life Science Research and Development, 2018, "Compliant GxP clouds are more recently aligned with International Society for Pharmaceutical Engineering (ISPE) Good Automated Manufacturing Practice (GAMP) guidelines and good practices, and support a risk-based approach to compliant GxP computerized systems." The report goes on to state that "Because there is an increased focus on reducing costs, resources and complexity, the need for GxP support on cloud platforms will increase." In our own research, Epista has found that the move to cloud requires a crystal-clear understanding of your company's optimal compliance level: the right intersection of risk versus resources-something unique for each company. Each company's optimal level must align both regulatory requirements and business objectives, focusing on eliminating overspending and reducing regulatory risk. Read more about a methodology to achieve this balance in the Epista CIRC© Compliance Platform.
According to Gartner's two Hype Cycle Reports, "Fewer than 20% of GxP processes for manufacturing groups are validated and handled entirely on cloud platform technology stacks. However, many organizations are beginning to explore this space." If your company is beginning to explore this space and would like more information on compliance in the cloud, read about Epista's Cloud Compliance services.
(1) Gartner, Hype Cycle for Life Sciences, 2018 by Stephen Davies, Michael Shanler and Jeff Smith. July 2018
(2 Gartner, Hype Cycle for Life Science Research and Development, 2018 by Michael Shanler and Jeff Smith. July 2018
(3) Gartner Accelerate Digital Capabilities by Migrating Validated Life Sciences Applications to the CLoud, August 2017, by Stephen Davies, Michael Shanler and Jeff Smith
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