Managing the documentation maze : answers to questions you didn't even know to ask /

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This book deals with a topic of critical importance for compliance with record-keeping regulations in pharmaceutical and medical device industries. It presents more than 750 questions and answers about documentation management, whether electronic or paper-based. It defines, through a Q & A appro...

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Bibliographic Details
Call Number:Libro Electrónico
Main Author: Gough, Janet
Other Authors: Nettleton, David, 1963-
Format: Electronic eBook
Language:Inglés
Published: Hoboken, N.J. : Wiley, ©2010.
Subjects:
Medical records > Automation.
Medical records > Data processing.
Documentation.
Forms and Records Control > organization & administration
Electronic Data Processing > organization & administration
Documentation
Medical Records Systems, Computerized > organization & administration
Dossiers médicaux > Automatisation.
Dossiers médicaux > Informatique.
documentation (activity)
TECHNOLOGY & ENGINEERING > Biomedical.
MEDICAL > Family & General Practice.
MEDICAL > Allied Health Services > Medical Technology.
MEDICAL > Biotechnology.
MEDICAL > Lasers in Medicine.
Online Access:Texto completo (Requiere registro previo con correo institucional)
Table of Contents:
  • Managing the documentation maze; contents; introduction; about the authors; chapter 1 understanding the regulations; chapter 2 people, process, and documentation; chapter 3 principles of document management; chapter 4 deciding to go electronic and finding a vendor; chapter 5 making the transition from hybrid to validated e-system; chapter 6 part 11 compliance; chapter 7 standard operating procedures; chapter 8 nonclinical records; chapter 9 clinical and submission records; chapter 10 consistency and readability in documents; chapter 11 maintaining the system.
  • Chapter 12 maintaining inspection readinesschapter 13 resources; appendix; index.

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