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Informationen zum Autor 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. Klappentext This book deals with a topic of critical importance for compliance with record-keeping regulations in pharmaceutical and medical device industries. It presents more than 750 questions and answers about documentation management, whether electronic or paper-based. It defines, through a Q&A approach, what document management actually is, and why it should be a core discipline in the industry. Questions and responses also address electronic system selection and validation, system security, user accountability, and audit trails, as well as standard operating procedures for supporting document systems. Finally, responses demystify the meaning of binding regulations. Zusammenfassung This book deals with a topic of critical importance for compliance with record-keeping regulations in pharmaceutical and medical device industries. It presents more than 750 questions and answers about documentation management, whether electronic or paper-based. Inhaltsverzeichnis 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. ...
