REDMOND, Wash. — June 24, 2013 — Microsoft Corp. today announced the release of third-party qualification guidelines for Microsoft’s cloud solutions Windows Azure and Microsoft Office 365, demonstrating that these platforms can address the necessary regulatory requirements for life sciences organizations to maintain compliance in the cloud. Microsoft is the only major combined infrastructure as a service (IaaS), platform as a service (PaaS) and software as a service (SaaS) public cloud provider to undergo an independent review of system documentation against GxP qualification requirements, the set of production and testing practices in FDA-regulated industries, demonstrating documentation against applicable regulations.
“As life sciences organizations move information to the cloud, they are required to leverage qualified cloud solutions that address necessary regulatory requirements,” said Andrea McGonigle, managing director, Life Sciences at Microsoft. “Microsoft is already a trusted data steward for healthcare organizations, and the ability to achieve GxP qualification for Windows Azure and Office 365 is a testament to our commitment to providing life sciences organizations with secured infrastructure and platforms in the cloud.”
Montrium, an organization specializing in quality assurance, regulatory GxP compliance and SaaS document collaboration and quality management solutions for the life sciences industry, conducted the qualification review of Microsoft’s Windows Azure and Office 365 solutions.
“When evaluating public, off-premises, cloud solutions, life sciences organizations must assess cloud service providers controls that help ensure confidentiality, integrity and availability of customer data,” said Paul Fenton, president and CEO, Montrium. “Microsoft has clearly demonstrated that these solutions have the necessary controls to provide a GxP-qualified cloud service. This coupled with the guidelines that Montrium has produced will enable life sciences organizations to deploy validated solutions on top of the Microsoft cloud platforms for processes like Regulated Document Management and Clinical Trials Management.”
Microsoft’s approach to providing qualified cloud platforms for life sciences organizations is to provide system documentation and certifications across a wide range of standards, such as ISO27001, SSAE16 SOC 1 and 2, HIPAA/HITECH and others, to enable customers and partners to qualify Microsoft’s cloud platforms. This qualification helps the customers or partners build and deploy validated applications that meet regulatory requirements, including FDA 21 CFR Part 11 Electronic Records, Electronic Signatures (21 CFR Part 11) and Eudralex Volume 4 – Annex 11 Computerised Systems (Annex 11).
More information on how Microsoft’s cloud solutions support qualified GxP applications is available via [email protected]. More information about how organizations are turning to Microsoft technology is available in the Microsoft Customer Spotlight newsroom.
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