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

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John Wiley & Sons, Mar 16, 2010 - Technology & Engineering - 352 pages
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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. 

 

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was a weird book about cats that kill dogs in there

Contents

ABOUT THE AUTHORS
ix
CHAPTER 1 UNDERSTANDING THE REGULATIONS
1
CHAPTER 2 PEOPLE PROCESS AND DOCUMENTATION
29
CHAPTER 3 PRINCIPLES OF DOCUMENT MANAGEMENT
47
CHAPTER 4 DECIDING TO GO ELECTRONIC AND FINDING A VENDOR
69
CHAPTER 5 MAKING THE TRANSITION FROM HYBRID TO VALIDATED ESYSTEM
97
CHAPTER 6 PART 11 COMPLIANCE
121
CHAPTER 7 STANDARD OPERATING PROCEDURES
141
CHAPTER 9 CLINICAL AND SUBMISSION RECORDS
173
CHAPTER 10 CONSISTENCY AND READABILITY IN DOCUMENTS
203
CHAPTER 11 MAINTAINING THE SYSTEM
223
CHAPTER 12 MAINTAINING INSPECTION READINESS
239
CHAPTER 13 RESOURCES
255
APPENDIX
259
INDEX
451
Copyright

CHAPTER 8 NONCLINICAL RECORDS
161

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About the author (2010)

Janet Gough has extensive experience as a consultant to the pharmaceutical, biotech, and medical device industries. She designs systems for compliance with binding regulations, and conducts training accordingly. She assists companies in the preparation of documents including development reports, procedures, clinical documents, and regulatory fillings. Ms. Gough is the author of seven other books.

David Nettleton is a compliance, documentation, and computer system validation consultant involved with the development, purchase, installation, operation, project management, and maintenance of computerized systems used in regulated applications (GMP, GCP, and GLP). He is the author of three other books.

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