Manish Baviskar, Hubot CDMO, on ALCOA++ data integrity, model version change control, continuous monitoring, and human sign-off.
News|Articles|September 15, 2019
Global Pharmacopoeia Standards: Why Harmonization is Needed (PDF)
Author(s)J. Mark Wiggins, Joseph A. Albanese
Pharmacopoeia harmonization provides better support for global regulatory agencies and addresses the global nature of bio/pharmaceutical manufacturing and supply.
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