“Life Science companies need to evolve,” said Klavs Esbjerg, CEO and Founder of Epista Life Science. “Technology vendors are driving the trend to cloud, which promises efficiency, transparency, and scalability—but compliance has to be considered.”
In recent research, Gartner cites Epista Life Science. Gartner analysts Stephen Davies, Michael Shanler, and Jeff Smith outline key challenges and recommendations for Life Science companies moving to the cloud in a regulated environment. According to Epista’s subject matter experts, the research, Accelerate Digital Capabilities by Migrating Validated Life Sciences Applications to the Cloud, is a valuable read for Life Science CXOs, QA and IT, or data-, process-, or system-owners.
We find that this research is relevant for both smaller, technologically flexible companies as well as larger companies with many legacy systems. According to Gartner, “CIOs in both of these organization types share a similar goal: leverage the cloud to increase organizational agility and flexibility” (Gartner, “Introduction).
Later in the publication, the analysts note that “developing a structured, repeatable and operationalized approach to evaluate, select and deploy regulated applications in the cloud is a must for life science organizations” (Gartner, “Leveraging the Cloud Validation Package Model for Regulated Applications”). That being said, “no clear guidance exists from regulatory bodies and the life science industry to drive the actual development of a complete model...This means that each life science organization must complete this model based on its own interpretation and risk acceptance as a collaborative effort between quality and IT.”
In our own research, Epista subject matter experts have found that the move to cloud requires a clear understanding of your optimal compliance level: the intersection of your quality objectives versus your compliance efforts. This optimal level takes into account both regulatory requirements and business objectives, focusing on eliminating overspending and reducing regulatory risk.
We recommend reading the full Gartner publication to obtain an overview of best practices to make your business more transparent, efficient, and flexible through cloud solutions. The 2017 Gartner research note is available here to licensed users.
Gartner Accelerate Digital Capabilities by Migrating Validated Life Sciences Applications to the Cloud, Davies, Stephen; Shanler, Michael; Smith, Jeff, 01 August 2017
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