Validation Non-Compliance: Review PIN is not sufficient for CFR Part 11 Section 200

Diana Fournier 10 months ago in Productivity Management updated 10 months ago 1

Our Validation Team has deemed that the Review PIN functionality for our validated review (which we call "Final Review" in our configuration) is not sufficient and that we are currently not compliant with CFR Part 11 Subsection 200 (screenshot attached).

This requires that there be TWO levels of validation, not just a Review PIN. 

Please let us know if you have suggestions from Michael Smith or other Life Sciences specialists at Aprimo.  We would welcome a conversation with our lead Validation colleague, Michael Falco, as well if you would find that helpful.


Diana Fournier