In two articles published in the January/February 2014 and September/October 2014 Pharmaceutical Engineering magazine, the GAMP® Cloud Special Interest Group (SIG) provided an overview of some of the primary challenges and concerns regarding whether cloud solutions can be adopted, as well as the specific challenges related to the Infrastructure as a Service (IaaS) delivery model.

The GAMP® Cloud Special Interest Group has now created three companion Concept Papers covering the topic of Software as a Service (SaaS) and Platform as a Service (PaaS):

SaaS in a Regulated Environment – The Impact of Multi-Tenancy and Subcontracting
Focuses on the SaaS cloud model description, various business models used by the SaaS providers, and security and privacy concerns related to those models.

Using SaaS in a Regulated Environment – A Lifeycle Approach to Risk Management
Provides a look into the relationship lifecycle of a regulated company and a SaaS provider, diving deeper into the issues a delivery team can face in moving a business supporting system to a SaaS provider.

Evolution of the Cloud: A Risk-Based Perspective on Leveraging PaaS within a Regulated Life Sciences Company
Intended to help explain how PaaS compares to other cloud solutions (specifically IaaS), as well as discussing risks and associated pragmatic controls that regulated companies should consider when leveraging PaaS within their organization.

As an ISPE member benefit, you have access to all three of these GAMP® Cloud SIG Concept Papers.

Not a member?  Join today to gain access to these Concept Papers and more!

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