By Ivan Soto

Published in: IVT Jr GXP Compliance Vol 24 Issue 3

Published on: May 26, 2020

Opening Sentences: This article will expand and cover in more details the topics discussed in the Voices of Validation podcast from January 2020 and will further discuss strategies about how to implement a risk-based data integrity and audit trail reviews process. WHY ARE WE HEARING MORE ABOUT AUDITS AND AUDIT TRAIL REVIEWS LATELY? There are three major factors impacting the amount of “noise” or attention during audits to audit trail reviews and data integrity.

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Audits • Change Control • Compliance • Data Integrity • Quality

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