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@Regulatory: May 2013

The cloud in Life Sciences- a regulatory perspective


The world, even for the life sciences industry, has drastically changed where the delivery and utilization of Information Technology (IT) is concerned. We went from mainframe to client-server to cloud computing (“the cloud”) in a matter of 50 years. Cloud computing technology has revolutionized the way information and supporting systems are being architected, implemented, and deployed. This rapid change has encroached upon the life sciences industry as well, and at the same time there is increasing pressure on the industry to reduce costs and increase efficiencies. Unlike other industries, the life sciences face the ever present concern of GxP (Good regulatory practices such as laboratory, clinical, and manufacturing) compliance, regardless of the technology platform that is used to support regulated activities. In this issue of @Regulatory, some of the regulatory risks and challenges facing the life sciences industry, how to apply a risk-based approach to help mitigate these risks when implementing a secure cloud environment, and what to consider when moving towards a GxP cloud solution are discussed.

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