The answer is? FDA publishes final data integrity Q&A

Despite much discussion about the subject over the past 3 years, in particular, data integrity issues remain a common feature on 483 letters issued by the USA Food and Drug Administration (FDA) and data handling matters are also a focus of enforcement actions (as well as inspection findings from other regulatory agencies). It is perhaps for this reason that the FDA has issued a new guidance document entitled Data Integrity and Compliance with Drug cGMP: Questions and Answers – Guidance for Industry.

In relation to this topic, Tim Sandle has written an article for GMP Review:

This article reviews the new FDA data integrity guidance document and draws out some items of interest for the pharmaceutical and healthcare sectors. The aim here is not to overly repeat what is in the document (since the reader could and should be doing this for themselves), but to note the differences between the final document and the earlier draft and to draw out the key themes within the document.

The reference is:

Sandle, T. (2019) The answer is? FDA publishes final data integrity Q&A, GMP Review, 17 (4): 4-7

For a copy, please contact Tim Sandle

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology