FDA's electronic record requirements
This article was originally published in The Gray Sheet
Executive Summary
To be the focus of an agency-sponsored Jan. 12 videoconference. Issues to be addressed include: validation of electronic record keeping systems, good manufacturing practices requirements for electronic record keeping, and an overview of FDA's Electronic Records and Electronic Signature regulation (21 CFR Part 11). A registration form is posted on FDA's website (www.fda.gov/cdrh)