Managing the Documentation Maze: Answers to Questions You Didn't Even Know to AskISBN: 978-0-470-46708-4
Hardcover
488 pages
March 2010
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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.
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