Guidance Addresses Questions on Data Integrity

April 20, 2016

In response to a slew of warning letters regarding data integrity issues, the FDA is addressing questions on the matter that have come up in recent inspections.

The 18 questions and their answers come in the form of draft guidance unveiled last week that covers a range of topics, including access to computers holding GMP data, how the validation process works, how often audits should be conducted and what data FDA inspectors are allowed to access.

After outlining some basic concepts, such as the gold standard for data integrity — that is, complete, consistent and accurate data that is attributable and certifiable — the document touches on the basic parameters of data preservation.