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. Continue reading WHO’s Draft Guidelines on Validation May 2016
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.