patrick-kenny
Team TFS
Team TFS
since ‎05-23-2018
‎07-22-2021

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Reading through some recent U.S. FDA Warning Letters to pharma manufacturers concerning data integrity, I came across a new one regarding a Chromatography Data System (CDS). There were a couple of very powerful sentences in the letter that companies ...
"You have all these audit trails, which provide great information about your testing, but none of your procedures tell you to review those audit trails. I'll expect to see that next time I'm here."Those were the words from an FDA inspector toward the...