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Data integrity in pharmaceutical and medical devices regulation operations : best practices guide to electronic records compliance / / Orlando Lopez
| Data integrity in pharmaceutical and medical devices regulation operations : best practices guide to electronic records compliance / / Orlando Lopez |
| Autore | Lopez Orlando |
| Pubbl/distr/stampa | Boca Raton : , : CRC Press/Taylor & Francis, , [2017] |
| Descrizione fisica | 1 online resource (395 pages) : illustrations, tables |
| Disciplina | 610.285 |
| Collana | Productivity Press Book |
| Soggetto topico |
Medical informatics
Pharmacy informatics Medical instruments and apparatus industry - Quality control |
| ISBN |
1-315-36709-2
1-315-34997-3 1-4987-7326-5 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 1. Introduction -- 2. Inspection trends -- 3. Electronic records life cycle -- 4. Electronic records related definitions -- 5. Electronic records handling : 21 CFR part 211 -- 6. Electronic records handling : EMA annex 11 -- 7. Relevant worldwide GMP regulations and guidelines -- 8. Trustworthy computer systems -- 9. MHRA guidance -- 10. Electronic records governance -- 11. Procedural controls for handling E-records -- 12. Electronic record controls : supporting processes -- 13. Electronic records controls : records retained by computer storage -- 14. Electronic record controls : during processing -- 15. Electronic record controls : while in transit -- 16. Electronic records and contract manufacturers -- 17. Electronic records and Cloud computing -- 18. Self-inspections -- 19. Electronic records remediation project -- 20. Summary. |
| Record Nr. | UNINA-9910149367503321 |
Lopez Orlando
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| Boca Raton : , : CRC Press/Taylor & Francis, , [2017] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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The FDA and worldwide quality system requirements guidebook for medical devices / / compiled and written by Amiram Daniel & Ed Kimmelman
| The FDA and worldwide quality system requirements guidebook for medical devices / / compiled and written by Amiram Daniel & Ed Kimmelman |
| Autore | Daniel Amiram |
| Edizione | [Second edition.] |
| Pubbl/distr/stampa | Milwaukee, Wisconsin : , : ASQ Quality Press, , 2008 |
| Descrizione fisica | 1 online resource (334 p.) |
| Disciplina | 344.7304/2 |
| Altri autori (Persone) | TrautmanKimberly A. <1964-> |
| Soggetto topico |
Medical instruments and apparatus industry - Law and legislation - United States
Quality control - Law and legislation - United States Medical instruments and apparatus industry - United States - Quality control Medical instruments and apparatus industry - Law and legislation Quality control - Law and legislation Medical instruments and apparatus industry - Quality control |
| ISBN |
0-87389-203-8
0-87389-204-6 600-00-4861-0 1-62198-206-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910789476403321 |
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Daniel Amiram
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| Milwaukee, Wisconsin : , : ASQ Quality Press, , 2008 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
The FDA and worldwide quality system requirements guidebook for medical devices / / compiled and written by Amiram Daniel & Ed Kimmelman
| The FDA and worldwide quality system requirements guidebook for medical devices / / compiled and written by Amiram Daniel & Ed Kimmelman |
| Autore | Daniel Amiram |
| Edizione | [Second edition.] |
| Pubbl/distr/stampa | Milwaukee, Wisconsin : , : ASQ Quality Press, , 2008 |
| Descrizione fisica | 1 online resource (334 p.) |
| Disciplina | 344.7304/2 |
| Altri autori (Persone) | TrautmanKimberly A. <1964-> |
| Soggetto topico |
Medical instruments and apparatus industry - Law and legislation - United States
Quality control - Law and legislation - United States Medical instruments and apparatus industry - United States - Quality control Medical instruments and apparatus industry - Law and legislation Quality control - Law and legislation Medical instruments and apparatus industry - Quality control |
| ISBN |
0-87389-203-8
0-87389-204-6 600-00-4861-0 1-62198-206-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910817373103321 |
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Daniel Amiram
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| Milwaukee, Wisconsin : , : ASQ Quality Press, , 2008 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
The FDA and worldwide quality system requirements guidebook for medical devices / / compiled and written by Amiram Daniel & Ed Kimmelman
| The FDA and worldwide quality system requirements guidebook for medical devices / / compiled and written by Amiram Daniel & Ed Kimmelman |
| Edizione | [Second edition.] |
| Pubbl/distr/stampa | Milwaukee, Wisconsin : , : ASQ Quality Press, , 2008 |
| Descrizione fisica | 1 online resource (334 p.) |
| Disciplina | 344.7304/2 |
| Altri autori (Persone) | TrautmanKimberly A. <1964-> |
| Soggetto topico |
Medical instruments and apparatus industry - Law and legislation - United States
Quality control - Law and legislation - United States Medical instruments and apparatus industry - United States - Quality control Medical instruments and apparatus industry - Law and legislation Quality control - Law and legislation Medical instruments and apparatus industry - Quality control |
| Soggetto genere / forma | Electronic books. |
| ISBN |
600-00-4861-0
1-62198-206-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910464166503321 |
| Milwaukee, Wisconsin : , : ASQ Quality Press, , 2008 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Medical device quality management systems : strategy and techniques for improving efficiency and effectiveness / / Susanne Manz
| Medical device quality management systems : strategy and techniques for improving efficiency and effectiveness / / Susanne Manz |
| Autore | Manz Susanne |
| Pubbl/distr/stampa | London, United Kingdom : , : Academic Press, an imprint of Elsevier, , [2019] |
| Descrizione fisica | 1 online resource (296 pages) |
| Disciplina | 338.47610280685 |
| Soggetto topico | Medical instruments and apparatus industry - Quality control |
| ISBN | 0-12-814222-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910583400203321 |
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Manz Susanne
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| London, United Kingdom : , : Academic Press, an imprint of Elsevier, , [2019] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Quality assurance journal
| Quality assurance journal |
| Pubbl/distr/stampa | [Chichester], : John Wiley & Sons, ©1996-©2011 |
| Descrizione fisica | 1 online resource |
| Disciplina | 615 |
| Soggetto topico |
Pharmaceutical technology - Quality control
Medical instruments and apparatus industry - Quality control Pollution control industry - Quality control Medical care - Quality control Environmental Medicine - standards Health Occupations - standards Quality Assurance, Health Care Techniques pharmaceutiques - Qualité - Contrôle Médecine - Appareils et instruments - Industrie - Qualité - Contrôle Environnement - Industrie - Qualité - Contrôle Soins médicaux - Qualité - Contrôle |
| Soggetto genere / forma | Periodicals. |
| ISSN | 1099-1786 |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Altri titoli varianti |
Qual Assur J
QA |
| Record Nr. | UNINA-9910555240803321 |
| [Chichester], : John Wiley & Sons, ©1996-©2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Soggetto topico
-
Medical instruments and apparatus industry - Quality control
(6)
- Medical instruments and apparatus industry - Law and legislation (3)
- Medical instruments and apparatus industry - Law and legislation - United States (3)
- Medical instruments and apparatus industry - United States - Quality control (3)
- Quality control - Law and legislation (3)