Industry Presses FDA to Spell Out Data Integrity Guidance

Industry is calling on the FDA to expound on its data integrity guidance to better define its expectations.

In comments on a draft guidance covering a range of GMP data integrity issues, representatives of industry and trade groups expressed frustration on the lack of specificity in the document’s 18-question guidance.

The Society of Quality Assurance proposed significant amendments to the draft, recommending the agency not limit its data integrity guidance just to GMP, but address areas such as good laboratory practices and good clinical practices.