David Nettleton, Janet Gough

Electronic Record Keeping

Achieving and Maintaining Compliance with 21 Cfr Part 11 and 45 Cfr Parts 160, 162, and 164

• Gebundenes Buch

Produktbeschreibung

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.

Produktdetails

• Verlag: CRC Press
• Seitenzahl: 384
• Erscheinungstermin: 29. Dezember 2003
• Englisch
• Abmessung: 248mm x 154mm x 25mm
• Gewicht: 658g
• ISBN-13: 9780849321641
• ISBN-10: 0849321646
• Artikelnr.: 22346916

Autorenporträt

David Nettleton

Inhaltsangabe

Electronic Record Keeping: The Big Picture. The Regulations: Not Just What
They Say, but What They Mean. Going Electronic: What You Need to Know and
Do. Documentation and Training. Security, Accountability, and Change
Management. Auditing Electronic Record Keeping Systems. Moving Forward.
Frequently Asked Questions.