Electronic Record Keeping: Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164

by David Nettleton and Janet Gough

Book Overview

The current revolution in software, and the regulations that have evolved to address it, have increasingly caused companies to turn to off-the-shelf software for electronic record keeping. Data captured in computerized systems must be as reliable, if not more so, than data on paper. Electronic Record Keeping: Achieving Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164 explores how to evaluate, select, implement, and document an e-system...

• Format: Hardcover
• Language: English
• ISBN: 0849321646
• ISBN13: 9780849321641
• Release Date: December 2003
• Publisher: CRC Press
• Length: 384 Pages
• Weight: 1.45 lbs.
• Dimensions: 1.0" x 6.1" x 9.8"