WHO’s Draft Guidelines on Validation May 2016

Hello good people of the world! On May 15, 2016, the World Health Organization released its draft Guidelines on Validation. It is available on the WHO website for download here.

This post covers my review of the guidance.

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Tracking C&Q Deviations with SharePoint

Hello good people of the world! This post is the first in a series on tracking C&Q (Commissioning and Qualification) deviations in a SharePoint site. This implementation assumes approvals are still done with wet signatures so there are no 21CFR11/Annex 11 compliance concerns.

This first post covers how to set up functionality to automatically add an MS Word document created from a template to a library by specifying metadata in an HTML form using Javascript in a Content Editor web part.