Electronic Records/Signatures Rule Being Reexamined By FDA
This article was originally published in The Tan Sheet
Executive Summary
Industry concerns about FDA's electronic records and signatures regulation - namely, the economic impact, industry practices and enforcement pertaining to the rule - are being considered by the agency, Center for Drug Evaluation & Research Office of Compliance Director Stephanie Gray told industry reps at the Consumer Healthcare Products Association's Manufacturing Controls Seminar in Philadelphia Oct. 7-8.