Buch, Englisch, 384 Seiten, Format (B × H): 154 mm x 248 mm, Gewicht: 658 g
Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164
Buch, Englisch, 384 Seiten, Format (B × H): 154 mm x 248 mm, Gewicht: 658 g
ISBN: 978-0-8493-2164-1
Verlag: CRC Press
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.
Zielgruppe
Professional
Autoren/Hrsg.
Fachgebiete
Weitere Infos & Material
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.