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

Name: Electronic Record Keeping
Author: Janet Gough

Auteur: David Nettleton

Taal: Engels

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Auteur: David Nettleton Janet Gough

Co-auteur: Nettleton Nettleton

Engels
Hardcover
9780849321641
29 december 2003
384 pagina's

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Samenvatting

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

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 that will keep your organization in compliance.

Covering Title 21 of the Code of Federal Regulations (CFR) Part 11 and the parallel, recently passed Title 45 CFR Parts 160, 162, and 164 of the Health Insurance Portability and Accountability Act (HIPAA), this book provides guidance for selecting, purchasing, installing, validating, and managing commercial off-the-shelf software for data collection and retention. It takes a number of years for industry standards for a new regulation to develop from dialog between companies and the regulating agency. These standards are in place for Part 11, which was passed into law in 1997. Healthcare providers who must implement electronic record keeping can learn how to best do it by understanding the parallel between the new HIPAA regulations and the industry standards for Part 11. Further, certain FDA-driven activities, such as patient record keeping in clinical trials, now must comply with the new HIPAA regs as well. To help companies achieve and maintain compliance, the authors cover audit trails, validation, documentation, training, and security and accountability. They discuss what the regulations say and what they mean.

Compliance may be mandatory, but it also makes good business sense. Companies that are compliant will always be poised to move forward, and they will avoid the grief that comes from poor or faulty record keeping and documentation. This book gives you the tools you need to keep your company both compliant and competitive.

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Inhoud

Taal: en
Bindwijze: Hardcover
Oorspronkelijke releasedatum: 29 december 2003
Aantal pagina's: 384
Illustraties: Nee

Betrokkenen

Hoofdauteur: David Nettleton
Tweede Auteur: Janet Gough
Co Auteur: Nettleton Nettleton
Hoofduitgeverij: CRC Press Inc

Overige kenmerken

Extra groot lettertype: Nee
Product breedte: 156 mm
Product lengte: 234 mm
Studieboek: Nee
Verpakking breedte: 156 mm
Verpakking hoogte: 234 mm
Verpakking lengte: 234 mm
Verpakkingsgewicht: 671 g

EAN

EAN: 9780849321641

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Categorieën: Managementboeken

Boeken
Taal: Engels
Boek, ebook of luisterboek?: Boek
Over welke sector: Uitgeverij & Boekhandel
Beschikbaarheid: Leverbaar

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