Open Daily: 10am - 10pm | Alley door pickup 10am - 7pm 3038 Hennepin Ave Minneapolis, MN
612-822-4611

  • Open Daily: 10am - 10pm
    Alley-side Pickup: 10am - 7pm

    3038 Hennepin Ave Minneapolis, MN
    612-822-4611

Open Daily: 10am - 10pm | Alley-side Pickup: 10am - 7pm
3038 Hennepin Ave Minneapolis, MN
612-822-4611
Electronic Record Keeping: Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164

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

Nettleton, David
Gough, Janet

Hardcover

Medical ReferenceBusiness of WritingGeneral Education

ISBN10: 0849321646
ISBN13: 9780849321641
Publisher: CRC Press
Published: Dec 29 2003
Pages: 384
Weight: 1.45
Height: 0.99 Width: 6.06 Depth: 9.78
Language: English
Covering the recently passed 45 CFR, 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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