FDA on Part 11
This article was originally published in The Tan Sheet
Executive Summary
Agency is "still on a very aggressive timeframe" to finalize its Part 11 electronic records guidance and expects completion in the "very near future," CDER Office of Compliance Division of Manufacturing & Product Quality Director Joe Famulare said at a June 16 FDA/industry workshop on drug GMPs. FDA received 61 comments on draft guidance, issued in February, and "more than a few" stated that other Part 11 compliance guidances that have been withdrawn by FDA "were valuable and should be re-issued," Famulare noted...