Part 11 Compliance and SharePoint–Part II

In the last blog post we talked about releasing our “draft guidance” at the DIA EDM show last week.  Today, we’re pleased to announce that the “Configuring SharePoint 2010 for 21 CFR Part 11 Compliance” document is available on our website on our “Compliant Collaboration” page.

The feedback we’ve received is interesting – as every organization we’ve spoken with has taken a different approach to compliance:


  • Some organizations are embracing the Digital Signature capabilities of SharePoint – and want to extend them even further to compliance with the SAFE BioPharma standard.  This is, of course, possible – and will be the subject of a future blog post.


  • Some organizations have asked about PDF support in the workflow and electronic signatures.  While this is possible, we didn’t approach this as we were approaching a pure Office System 2010 environment.  Not realistic?  Perhaps – but your feedback on the topic is essential in helping us write the final document.


So – download the whitepaper.  Take a read.  Test it out.  If your company is looking for assistance in testing it out, let us know – we’ll put you in touch with the appropriate people at  Paragon Solutions that helped us by building out the environment.  Or contact them directly at


Looking forward to your feedback!

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