Managing the Documentation Maze – Answers to ions You Didn′t Even Know to Ask

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 fillings. 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.

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.