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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 11 applicable to drugs and devices as well. It is updated with highlights to reflect changes due to FDA’s Part 11 Redirection in Feb 2003 after the books publication.
View the article at this link: AABBPart11BookChapt6-Feb2003RedirectionUpdatewithSCPRcoverpage
This chapter reprint is available to subscribers of SoftwareCPR.com. Any further distribution would violate the AABB copyright. Please observe the copyright.