Vai al contenuto principale della pagina
Autore: | Lopez Orlando |
Titolo: | Data integrity in pharmaceutical and medical devices regulation operations : best practices guide to electronic records compliance / / Orlando Lopez |
Pubblicazione: | Boca Raton : , : CRC Press/Taylor & Francis, , [2017] |
©2017 | |
Descrizione fisica: | 1 online resource (395 pages) : illustrations, tables |
Disciplina: | 610.285 |
Soggetto topico: | Medical informatics |
Pharmacy informatics | |
Medical instruments and apparatus industry - Quality control | |
Nota di bibliografia: | Includes bibliographical references at the end of each chapters and index. |
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. |
Titolo autorizzato: | Data integrity in pharmaceutical and medical devices regulation operations |
ISBN: | 1-315-36709-2 |
1-315-34997-3 | |
1-4987-7326-5 | |
Formato: | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione: | Inglese |
Record Nr.: | 9910149367503321 |
Lo trovi qui: | Univ. Federico II |
Opac: | Controlla la disponibilità qui |