In
April 2012, Microsoft published a White Paper titled SharePoint Configuration
Guidance for 21 CFR Part 11 Compliance – I urge any SharePoint person involved in with Computer Systems Validation (CSV) subject to read it.
It’s rudimentary and unlikely
that you will use exactly the use cases mentioned, but the concepts are there.
It mentions one or two server technologies which may not be available in tightly
governed organisations but I think that the real value is where it goes on to detail what can
be done with Microsoft Office 2010 and SharePoint 2010
out-of-the-box.
Whether you agree or disagree,
it then goes on to explain how exactly the Office clients and the SharePoint
server platform meet aspects of 21 CFR Part 11
Compliance.
Direct link to the
white paper: http://download.microsoft.com/download/9/A/A/9AA9CACF-B414-466B-BBED-86507D1D24FF/SharePoint-Configuration-Guidance-for-21-CFR-Part-11-Compliance.pdf
