Compliance with regulations in pharmaceutical, biolo
Trade Review
"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)
Table of 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.
