Electronic Record Keeping

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

Autori

• David Nettleton
• Janet Gough

Parametri

• 384 pagine
• 14 ore di lettura

• Biologia
• Scienze Naturali

Maggiori informazioni sul libro

Understanding the intersection of HIPAA regulations and industry standards is crucial for healthcare providers implementing electronic record keeping. The authors emphasize the importance of compliance with FDA-driven activities, particularly in clinical trials. They provide guidance on audit trails, validation, documentation, training, and security measures. By clarifying regulatory requirements, the book illustrates that compliance not only meets legal obligations but also enhances business efficiency, ensuring that companies remain competitive and avoid the pitfalls of inadequate record management.

Lingua: Inglese

Pubblicato: 2003

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