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

Covering the recently passed 45 CFR, and the parallel CFR 21 Part 11 and HIPAA regulations 160, 162, and 164, this book provides guidance for purchasing, installing, validating, and managing commercial off-the-shelf software data for collection and retention. Addressing the interface between these regulations and how to be in compliance with them, the authors cover audit trails, validation, documentation, training, and how to establish and maintain security and accountability. They discuss what the regulations mean in terms of industry standard, explain the audit function for facilities that are subject to the newer HIPAA regulations, and present the standards for documentation.

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