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Record Nr. |
UNINA9910149367503321 |
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Autore |
Lopez Orlando |
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Titolo |
Data integrity in pharmaceutical and medical devices regulation operations : best practices guide to electronic records compliance / / Orlando Lopez |
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Pubbl/distr/stampa |
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Boca Raton : , : CRC Press/Taylor & Francis, , [2017] |
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©2017 |
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ISBN |
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1-315-36709-2 |
1-315-34997-3 |
1-4987-7326-5 |
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Edizione |
[1st ed.] |
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Descrizione fisica |
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1 online resource (395 pages) : illustrations, tables |
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Collana |
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Disciplina |
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Soggetti |
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Medical informatics |
Pharmacy informatics |
Medical instruments and apparatus industry - Quality control |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Nota di bibliografia |
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Includes bibliographical references at the end of each chapters and index. |
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Nota di contenuto |
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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. |
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Sommario/riassunto |
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Data integrity is fundamental in a pharmaceutical and medical devices quality system. This book provides practical information to enable compliance with data integrity, while highlighting and efficiently |
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