Managing the documentation maze answers to questions you didn't even know to ask
The accessible, easy-to-follow guide that demystifies documentation management When it comes to receiving documentation to confirm good science, U.S. and international regulators place high demands on the healthcare industry. As a result, companies developing and manufacturing therapeutic products m...
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| Format: | eBook |
| Language: | Inglés |
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Hoboken, N.J. :
Wiley
c2010.
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| Edition: | 1st edition |
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| See on Biblioteca Universitat Ramon Llull: | https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009628235506719 |
Table of 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 READINESSCHAPTER 13 RESOURCES; APPENDIX; FEDERAL REGISTER; GUIDANCE FOR INDUSTRY; INDEX
