Drug Safety Europe 2016

Ensuring Compliance for Cloud: A Risk Management Guide for Life Sciences Organizations

In an effort to manage cost pressures, optimize operational efficiencies, and build robust IT capabilities, the life sciences industry is also shifting to the cloud. However, being a highly regulated industry, players face significant compliance challenges while leveraging the cloud. In addition to managing security risks in a shared computing environment, organizations also need to ensure that regulatory commitments are met effectively.

Life science organizations have been maximizing cloud adoption for non-regulated and non-mission critical applications. However, industry players have been conservative in shifting their regulated services to the cloud. Unlike infrastructure and applications hosted in-house, applications on the cloud pose multiple challenges in terms of security and data privacy. This makes it difficult to maintain compliance with regulatory requirements pertaining to  electronic records and electronic signatures. Ensuring accountability and managing risks are the key challenges that organizations face in embracing cloud as the IT environment is managed by the service provider.

To advance cloud adoption and facilitate better governance, organizations should consider conducting due diligence and defining roles and responsibilities to ensure ownership as well as enhance accountability of the service provider. This white paper evaluates the various options available for cloud adoption within the life sciences domain. It also discusses viable adoption models and ways to ensure regulatory compliance.

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