Newsletter | February 11, 2020

02.11.20 -- People: The Most Persistent Risk To Data Integrity

Featured Editorial
Sampling And Testing Of ATMPs: Gaining Insights From PIC/S Annex 2A
By Herman F. Bozenhardt and Erich H. Bozenhardt

With minimal specific guidance on commercial manufacturing from the FDA and a lack of robust platform commercial processes, some of the finer details of cell and therapy manufacturing can make operating companies feel like they are walking on a precarious limb.

People: The Most Persistent Risk To Data Integrity
By Kip Wolf, Tunnell Consulting, @KipWolf

HR changes continually impact overall data integrity—from a single new hire to a corporate-level change with a merger or acquisition. It's a commonly overlooked weak link in the data integrity chain.

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