Data integrity in pharmaceutical and medical devices regulation operations : best practices guide to electronic records compliance / / Orlando Lopez

• Autore: Lopez Orlando
• 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