Is SharePoint 2016 On premise GxP compliant?

Question

Dear team,

We are assessing the possibility of using SharePoint 2016.
However we need a confirmation on whether SharePoint 2016 On Premise is completely GxP complaint?

Do we have a documentation for SharePoint 2016 Gxp compliance?

Answer 1

@Amit Dimri

Per my knowledge, SharePoint 2016 is compliant with GxP.

According to this Microsoft article, GxP regulations include those requirements outlined in the US Food and Drug Administration (FDA) CFR Title 21 Part 11 and EudraLex Volume 4—GMP Guidelines, Annex 11 in the European Union (EU). In 2012, Microsoft published it’s own whitepaper entitled “SharePoint Configuration Guidance for 21 CFR Part 11 Compliance”.

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