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, Managing Partner of SoftwareCPR.  While the chapter has some information specific to Blood Establishment computer systems, it is primarily a general text on Part . . .

Thank you for your interest!  To view our Premium or Standards Navigator content, please click here to select the plan that best fits your needs.