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Managing the documentation maze : answers to questions you didn't even know to ask /
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 appro...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Otros Autores: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Hoboken, N.J. :
Wiley,
©2010.
|
| Temas: | |
| Acceso en línea: | Texto completo Texto completo |
MARC
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| 100 | 1 | |a Gough, Janet. | |
| 245 | 1 | 0 | |a Managing the documentation maze : |b answers to questions you didn't even know to ask / |c Janet Gough, David Nettleton. |
| 260 | |a Hoboken, N.J. : |b Wiley, |c ©2010. | ||
| 300 | |a 1 online resource (ix, 474 pages) : |b illustrations | ||
| 336 | |a text |b txt |2 rdacontent | ||
| 337 | |a computer |b c |2 rdamedia | ||
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| 504 | |a Includes bibliographical references and index. | ||
| 588 | 0 | |a Print version record. | |
| 505 | 0 | |a 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. | |
| 505 | 8 | |a Chapter 12 maintaining inspection readinesschapter 13 resources; appendix; index. | |
| 520 | |a 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 syste. | ||
| 546 | |a English. | ||
| 590 | |a ProQuest Ebook Central |b Ebook Central Academic Complete | ||
| 590 | |a O'Reilly |b O'Reilly Online Learning: Academic/Public Library Edition | ||
| 650 | 0 | |a Medical records |x Automation. | |
| 650 | 0 | |a Medical records |x Data processing. | |
| 650 | 0 | |a Documentation. | |
| 650 | 1 | 2 | |a Forms and Records Control |x organization & administration |
| 650 | 2 | 2 | |a Electronic Data Processing |x organization & administration |
| 650 | 2 | 2 | |a Documentation |
| 650 | 2 | 2 | |a Medical Records Systems, Computerized |x organization & administration |
| 650 | 6 | |a Dossiers médicaux |x Automatisation. | |
| 650 | 6 | |a Dossiers médicaux |x Informatique. | |
| 650 | 6 | |a Documentation. | |
| 650 | 7 | |a documentation (activity) |2 aat | |
| 650 | 7 | |a TECHNOLOGY & ENGINEERING |x Biomedical. |2 bisacsh | |
| 650 | 7 | |a MEDICAL |x Family & General Practice. |2 bisacsh | |
| 650 | 7 | |a MEDICAL |x Allied Health Services |x Medical Technology. |2 bisacsh | |
| 650 | 7 | |a MEDICAL |x Biotechnology. |2 bisacsh | |
| 650 | 7 | |a MEDICAL |x Lasers in Medicine. |2 bisacsh | |
| 650 | 7 | |a Documentation |2 fast | |
| 650 | 7 | |a Medical records |x Automation |2 fast | |
| 650 | 7 | |a Medical records |x Data processing |2 fast | |
| 700 | 1 | |a Nettleton, David, |d 1963- |1 https://id.oclc.org/worldcat/entity/E39PCjtBhvYc88b6TF9bVMfMGd | |
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