Managing the Documentation Maze : Answers to Questions You Didn't Even Know to Ask.
Title:
Managing the Documentation Maze : Answers to Questions You Didn't Even Know to Ask.
Author:
Gough, Janet.
ISBN:
9780470597491
Personal Author:
Edition:
1st ed.
Physical Description:
1 online resource (486 pages)
Contents:
MANAGING THE DOCUMENTATION MAZE -- CONTENTS -- 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 VALIDATED E-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.
Abstract:
"Managing the Documentation Maze is an excellent reference source in an easy-to-follow Q&A format for all healthcare professionals involved in the drug discovery process, development and manufacture of therapeutic products. Questions regarding all aspects of document management, validation, regulatory compliance, transition to electronic systems are clearly answered is an uncomplicated style by the authors, based on their extensive industry experience. I would, therefore, highly recommend this handy guide to all healthcare professional as 'Aide-mémoire', to quickly resolve and comply with rigorous regulatory standards required of the industry today." -Tom Blackburn, TPBioventures, LLC.
Local Note:
Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2017. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.
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Electronic Access:
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