Managing the documentation maze : answers to questions you didn't even know to ask / / Janet Gough, David Nettleton
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| Autore: |
Gough Janet
|
| Titolo: |
Managing the documentation maze : answers to questions you didn't even know to ask / / Janet Gough, David Nettleton
|
| Pubblicazione: | Hoboken, N.J., : Wiley, c2010 |
| Edizione: | 1st edition |
| Descrizione fisica: | 1 online resource (486 p.) |
| Disciplina: | 610.285 |
| Soggetto topico: | Medical records - Automation |
| Medical records - Data processing | |
| Altri autori: |
NettletonDavid <1963->
|
| Note generali: | Includes index. |
| Nota di bibliografia: | Includes bibliographical references and index. |
| Nota di contenuto: | 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 | |
| Sommario/riassunto: | 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 must implement a strategy that allows them to properly manage their records and documents, since they must comply with rigorous standards and be available for regulatory review or inspection at a moment's notice. Written in a user-friendly Q&A style for quick reference, Managing the Doc |
| Titolo autorizzato: | Managing the documentation maze |
| ISBN: | 1-282-54990-1 |
| 9786612549908 | |
| 0-470-59750-X | |
| 0-470-59749-6 | |
| Formato: | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione: | Inglese |
| Record Nr.: | 9910820943503321 |
| Lo trovi qui: | Univ. Federico II |
| Opac: | Controlla la disponibilità qui |