Managing the Documentation Maze: Answers to Questions You Didn't Even Know to Ask

Managing the Documentation Maze Answers to Questions You Didn't Even Know to Ask

The accessible, easy-to-follow guide that demystifies documentation management When it comes to receiving documentation to confirm good science, U.S. and international regulators place high demands on the healthcare industry. As a result, companies developing and manufacturing therapeutic products m...

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Bibliographic Details
Main Author: Janet Gough, David Nettleton
Format: eBook
Language:English
Published: Newark Wiley 2010
John Wiley & Sons, Incorporated
Wiley-Blackwell
Edition:1
Subjects:
Automation
Data processing
Medical records
TECHNOLOGY & ENGINEERING
Online Access:Get full text
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Table of Contents:
  • Intro -- 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 READINESS -- CHAPTER 13 RESOURCES -- APPENDIX -- FEDERAL REGISTER -- GUIDANCE FOR INDUSTRY -- INDEX