WIll Office 365 be GMP or HIPAA compliant?
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12. února 2011 23:13Infrastructure used to manage GMP related or HIPAA related information (such as pharmaceutical manufacturing batch data or clinical trial patient information needs to be qualified as meeting FDA regulatory requirements - much like financial data for public companies needs to meet Sorbanes Oxley requirements. Is Microsoft working with FDA and/or the Pharmaceutical Industry to meet these requirements?
Všechny reakce
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15. února 2011 16:32
Hi,
Do you mean you would like to see validation documentation from Microsoft such as an installation qualification (IQ)? They would also need to provide transparent documentation around changes to the configuration of their environment. I think this would be really hard to accomplish without Microsoft having to provide detailed, confidential, information on how they've architected their environment. I'm guessing they won't do this for customers who are not in a dedicated environment.
On a side note, we are using a vendor to provide a validated SharePoint 2010 based eDMS environment. This can be a platform for managing several Pharma related processes. They are hosting the systems and providing the IQ. We will run the OQ/PQ. They also have allowed us to audit their environment which is in compliance with our Vendor qualification requirements. I'm guessing MS won't let you stop by their datacenter for an audit. So, we plan on using BPOS/365 for our non-validated SharePoint stuff and using another vendor who specializes in the Pharmaceutical industry to provide our validated environment.
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25. května 2011 17:36To the best of my knowledge Office 365 should be HIPAA compliant. I don't recall information regarding GMP. That does not imply that it isn't going to be there, it just means I don't have any information regarding it.
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5. června 2011 19:13
Yes, Office 365 will be HIPAA and GMP compliant. They are not yet FISMA compliant, but then again no one really is unless you go to the dedicate space. But that is also in the works.
Thanks,
Jorge R. Diaz, PMP, CCNA, MCSA, MCSE, MCTS
Senior Microsoft Consultant
Check out My Blog! -
11. června 2011 11:54
As an update directly from the Microsoft team I work with:
At GA we will have EU Safe Harbor, ISO27001, FERPA,GLBA and PCI certifications with FISMA and SAS70 soon after.
Jorge R. Diaz, PMP, CCNA, MCSA, MCSE, MCTS
Senior Microsoft Consultant
Check out My Blog!- Navržen jako odpověď Jorge R. Diaz - PlanetMVP 11. června 2011 11:54
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