Microsoft's cloud platforms for life sciences organizations have achieved the qualifications set by the Food and Drug Administration to help customers validate Microsoft's offerings.
Windows Azure and Microsoft Office 365 passed the third-party system documentation review against GxP requirements for production and testing practices, Microsoft said Monday.
Quality management services provider Montrium administered the review on the cloud solutions, which aim to help life sciences organizations comply with regulations, including ISO 27001, SSAE 16 SOC 1 and 2, and HIPAA/HITECH.
“Microsoft has clearly demonstrated that these solutions have the necessary controls to provide a GxP-qualified cloud service,“ said Paul Fenton, president and CEO at Montrium.
These standards are intended to help clients develop applications that address FDA 21 CFR electronic records, electronic signatures and Eudralex volume 4 – annex 11 computerized systems requirements.
Andrea McGonigle, managing director for life sciences at Microsoft, said the company's GxP qualification underscores its efforts to provide customers with secure cloud-based infrastructure and platforms.