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?

La suite ici 

Posts les plus consultés de ce blog

On déménage...

Five ways machine learning will transform manufacturing in 2021