Cover image for 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

Author David Nettleton , Janet Gough
Release Date: 2010/03/01
ISBN: 9780470467084
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Book Description

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 must implement a strategy that allows them to properly manage their records and documents, since they must comply with rigorous standards and be available for regulatory review or inspection at a moment's notice.

Written in a user-friendly Q&A style for quick reference, Managing the Documentation Maze provides answers to 750 questions the authors encounter frequently in their roles as consultants and trainers. In simple terms, this handy guide breaks down the key components that facilitate successful document management, and shows why it needs to be a core discipline in the industry with information on:

  • Compliance with regulations in pharmaceutical, biological, and device record keeping

  • Electronic systems, hybrid systems, and the entire scope of documentation that companies must manage

  • How to write and edit documents that meet regulatory compliance

  • Making the transition to an electronic system, including how to validate and document the process

Anyone responsible for managing documents in the health field will find this book to be a trusted partner in unraveling the bureaucratic web of confusion, while it initiates a plan on how to put an effective, lasting system in place—one that will stand up to any type of scrutiny.

Table of Contents

  1. Cover Page
  2. Title Page
  3. Copyright
  4. CONTENTS
  5. INTRODUCTION
  6. ABOUT THE AUTHORS
  7. CHAPTER 1: UNDERSTANDING THE REGULATIONS
    1. INTRODUCTION
    2. REFERENCES
  8. CHAPTER 2: PEOPLE, PROCESS, AND DOCUMENTATION
    1. INTRODUCTION
    2. REFERENCES
  9. CHAPTER 3: PRINCIPLES OF DOCUMENT MANAGEMENT
    1. INTRODUCTION
    2. REFERENCES
  10. CHAPTER 4: DECIDING TO GO ELECTRONIC AND FINDING A VENDOR
    1. INTRODUCTION
    2. REFERENCE
  11. CHAPTER 5: MAKING THE TRANSITION FROM HYBRID TO VALIDATED E-SYSTEM
    1. INTRODUCTION
    2. REFERENCES
  12. CHAPTER 6: PART 11 COMPLIANCE
    1. INTRODUCTION
    2. REFERENCES
  13. CHAPTER 7: STANDARD OPERATING PROCEDURES
    1. INTRODUCTION
    2. REFERENCES
  14. CHAPTER 8: NONCLINICAL RECORDS
    1. REFERENCES
  15. CHAPTER 9: CLINICAL AND SUBMISSION RECORDS
    1. INTRODUCTION
    2. REFERENCES
  16. CHAPTER 10: CONSISTENCY AND READABILITY IN DOCUMENTS
    1. INTRODUCTION
    2. REFERENCES
  17. CHAPTER 11: MAINTAINING THE SYSTEM
    1. INTRODUCTION
    2. REFERENCE
  18. CHAPTER 12: MAINTAINING INSPECTION READINESS
    1. INTRODUCTION
    2. REFERENCES
  19. CHAPTER 13: RESOURCES
    1. INTRODUCTION
  20. APPENDIX
  21. FEDERAL REGISTER
  22. GUIDANCE FOR INDUSTRY
  23. Index
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