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jeudi 24 octobre 2019

ALCOA+ and Data Integrity


ALCOA+ and Data Integrity


Data supporting the quality and safety of product must meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
Oct 02, 2019
Volume 43, Issue 10, pg 77
Q: I am familiar with the term ALCOA as it relates to data integrity, but lately, I have heard people refer to ALCOA+. Can you explain what impact this new acronym has on my company’s data integrity program?

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