From the Experts Blog - Montrium

Articles from Montrium's Expert Professional Services team!

It’s no big secret that the regulated industry of the life sciences is regarded as extremely conservative, detail-oriented and risk-averse. As a result, when compared to other industries, life science companies have been slower to adopt cloud-based solutions including SaaS, PaaS, and IaaS 

One of the reasons giving companies ‘cold feet’ when it comes to making the transition is due to concern over the shift in control regarding software, platform and infrastructure design and development. The traditional ways of implementing change control, configuration management, and logical security are challenged as responsibilities transfer towards the cloud service provider making changes in the system. 

Despite reservations, more and more life science companies are recognizing the need to transition to cloud technologies in order to encourage innovation and to remain competitive. Cloud service providers can facilitate these customers’ transition to the cloud by being fully transparent about the standards and practices they follow. Providing this information reassures life science organizations that the service provider’s processes are in line with the expectations of GxP regulated industries.  

Microsoft is no exception. Just like other cloud service providers, Microsoft must earn the trust of its customers and potential customers. For life science companies who are considering Office 365 as a business solution, here is a list of qualifying resources that may alleviate some of the concerns about Microsoft’s ability to provide Office 365 services in a manner that meets GxP expectations.

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Where do Annex 11 and Part 11 intersect?