FDA Part 11 compliance


Tech Trek – 2011.07.14

I’m conducting research on US Food and Drug Administration’s (FDA) Part 11 compliance which deals with regulatory requirements for electronic records and signatures. It is an interesting topic especially with the today’s reliance in computer technology and transition of most enterprises from paper-based system into digital medium.

I was able to find the following reference written by Microsoft since my expertise lies in the of use SharePoint for content management. I’ll update this blog as I find more details about what the process entails.

Draft SharePoint 2010 Configuration Guide for 21 CFR Part 11 Compliance (xps format)

Microsoft Life Sciences

UPDATED [2011 July 23]:
See blog post update in the comments.

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3 thoughts on “FDA Part 11 compliance

  1. Just finished reading up the configuration guide mentioned in this post. I’ll start with what I liked about the paper.

    First and foremost, the guide elaborated point-by-point how the solution satifies the pertinent rules of FDA requirements for subpart B & C. Also, the document listed the different technologies that made up electronic documents regulatory compliance based on Microsoft’s offering. Now, that is either a good or bad thing since it was “biased” towards a particular vendor solution.

    The copy I reviewed was a draft release back in February 2011. Unfortunately, it was annoying to have incorrect screenshots in some sections including the redudant items for multiple signatures use cases. Also, there were a couple of incomplete areas i.e. sub-headers, missing references, etc. As such, pick and choose what will be useful on your end.

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