Gough / Nettleton Managing the Documentation Maze

Answers to Questions You Didn't Even Know to Ask
1. Auflage 2010
ISBN: 978-0-470-59749-1
Verlag: John Wiley & Sons
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 488 Seiten, E-Book

The accessible, easy-to-follow guide that demystifiesdocumentation management
When it comes to receiving documentation to confirm goodscience, U.S. and international regulators place high demands onthe healthcare industry. As a result, companies developing andmanufacturing therapeutic products must implement a strategy thatallows them to properly manage their records and documents, sincethey must comply with rigorous standards and be available forregulatory 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 750questions the authors encounter frequently in their roles asconsultants and trainers. In simple terms, this handy guide breaksdown the key components that facilitate successful documentmanagement, and shows why it needs to be a core discipline in theindustry with information on:
* Compliance with regulations in pharmaceutical, biological, anddevice record keeping
* Electronic systems, hybrid systems, and the entire scope ofdocumentation that companies must manage
* How to write and edit documents that meet regulatorycompliance
* Making the transition to an electronic system, including how tovalidate and document the process
Anyone responsible for managing documents in the health fieldwill find this book to be a trusted partner in unraveling thebureaucratic web of confusion, while it initiates a plan on how toput an effective, lasting system in place--one that will standup to any type of scrutiny.

Autoren/Hrsg.

Gough, Janet

Nettleton, David

Inhaltsverzeichnis

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 VALIDATEDE-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.

Über Autor(innen)

Janet Gough has extensive experience as a consultant to thepharmaceutical, biotech, and medical device industries. She designssystems for compliance with binding regulations, and conductstraining accordingly. She assists companies in the preparation ofdocuments including development reports, procedures, clinicaldocuments, and regulatory fillings. Ms. Gough is the author ofseven other books.
David Nettleton is a compliance, documentation, andcomputer system validation consultant involved with thedevelopment, purchase, installation, operation, project management,and maintenance of computerized systems used in regulatedapplications (GMP, GCP, and GLP). He is the author of three otherbooks.