Today at the DIA EDM (Electronic Data Management) conference, we are taking the wrappers off a new whitepaper the covers how to configure SharePoint 2010 in a 21 CFR Part 11 regulated environment. This whitepaper is a joint effort between Microsoft Life Sciences and Paragon’s Life Sciences consulting practice.
As in the tradition of all things related to the FDA, this is DRAFT guidance. Frankly, we are looking and asking for feedback. If the approach is different than what you’d take or if something just doesn’t work (despite our best efforts), please send us feedback. We want to hear from you.
The approach in this whitepaper is very different from all previous papers from Microsoft that deal with compliance: Instead of just saying “it can be compliant because of these features”, we took a use case approach. By enumerating use cases, we take an approach that is closer to what your company will do when validating the software. And while this is not completely prescriptive – neither Microsoft nor Paragon states doing these steps in this whitepaper will make you compliant – this paper is intended to provide guidance for your validation documentation.
The paper itself will appear on both Microsoft’s and Paragon’s websites later this week. In the meantime, feel free to e-mail me directly at firstname.lastname@example.org for a copy of the whitepaper or – even as importantly – to provide feedback.