Manish Baviskar, Hubot CDMO, on ALCOA++ data integrity, model version change control, continuous monitoring, and human sign-off.
News|Articles|September 15, 2019
Why Pharmacopoeia Compliance Is Difficult–An End-to-End Compendial Framework (PDF)
Author(s)J. Mark Wiggins, Joseph A. Albanese
This article provides an end-to-end compendial framework to understand why compliance with pharmacopoeia standards is challenging.
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