This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The attached document is a reprint of a chapter from an AABB book. The book is titled "Information Technology in Infusion Medicine".  The chapter is on 21 CFR Part 11 Electronic Records;Electronic Signatures and was authored by Alan Kusinitz,...Read More

This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR has prepared an audit checklist for assessing compliance with 21 CFR Part 11 Electronic Records and Electronic Signatures regulation.  The checklist is intended for use by expert assessors knowledgeable in the regulation, its preamble, history, and current enforcement...Read More