Managing the Documentation Maze: Answers to Questions You Didn't Even Know to Ask / Edition 1

by Janet Gough, David Nettleton

Overview

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. 

Product Details

ISBN-13:	9780470467084
Publisher:	Wiley
Publication date:	03/22/2010
Pages:	488
Product dimensions:	6.40(w) x 9.30(h) x 1.30(d)

About the Author

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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Table of Contents

Introduction vii

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 E-System 97

Chapter 6 Part 11 Compliance 121

Chapter 7 Standard Operating Procedures 141

Chapter 8 Nonclinical Records 161

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

Federal Register 261

Guidance for Industry 431

Index 451

What People are Saying About This

From the Publisher

"Managing the Documentation Maze is an excellent referencesource in an easy-to-follow Q&A format for all healthcareprofessionals involved in the drug discovery process, developmentand manufacture of therapeutic products. Questions regarding allaspects of document management, validation, regulatory compliance,transition to electronic systems are clearly answered is anuncomplicated style by the authors, based on their extensiveindustry experience. I would, therefore, highly recommend thishandy guide to all healthcare professional as 'Aide-mémoire',to quickly resolve and comply with rigorous regulatory standardsrequired of the industry today."
—Tom Blackburn, TPBioventures, LLC

Editorial Reviews

"Managing the Document Maze takes a fascinating and extremely effective approach to its topic . . . this organisational framework makes it very easy to target information that will answer specific questions of interest to the reader, while also providing a comprehensive overview of key information . . .Managing the Document Maze is recommended to readers, and receives the JCS Library Award." (Journal for Clinical Studies, 1 July 2010)

 

From the Publisher