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

by Gough, Janet; Nettleton, David

• ISBN13: 9780470467084
• ISBN10: 0470467088
• Edition: 1st
• Format: Hardcover
• Copyright: 2010-03-22
• Publisher: Wiley

Summary

This book deals with a topic of critical importance for compliance with record-keeping regulations in pharmaceutical and medical device industries. It presents more than 750 questions and answers about documentation management, whether electronic or paper-based. It defines, through a Q&A approach, what document management actually is, and why it should be a core discipline in the industry. Questions and responses also address electronic system selection and validation, system security, user accountability, and audit trails, as well as standard operating procedures for supporting document systems. Finally, responses demystify the meaning of binding regulations.

Author Biography

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 filings. 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.

Table of Contents

Introduction	p. vii
About the Authors	p. ix
Understanding the Regulations	p. 1
People, Process, and Documentation	p. 29
Principles of Document Management	p. 47
Deciding to go Electronic and Finding a Vendor	p. 69
Making the Transition from Hybrid to Validated E-System	p. 97
Part 11 Compliance	p. 121
Standard Operating Procedures	p. 141
Nonclinical Records	p. 161
Clinical and Submission Records	p. 173
Consistency and Readability in Documents	p. 203
Maintaining the System	p. 223
Maintaining Inspection Readiness	p. 239
Resources	p. 255
Appendix	p. 259
Federal Register	p. 261
Guidance for Industry	p. 431
Index	p. 451
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