Buch, Englisch, 394 Seiten, Format (B × H): 187 mm x 264 mm, Gewicht: 898 g
Best Practices Guide to Electronic Records Compliance
Buch, Englisch, 394 Seiten, Format (B × H): 187 mm x 264 mm, Gewicht: 898 g
ISBN: 978-1-4987-7324-9
Verlag: Taylor & Francis Inc
Zielgruppe
Professional Practice & Development
Autoren/Hrsg.
Fachgebiete
- Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Krankenhausmanagement, Praxismanagement
- Wirtschaftswissenschaften Betriebswirtschaft Management Qualitätsmanagement, Qualitätssicherung (QS), Total Quality Management (TQM)
- Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie
Weitere Infos & Material
Preface. Introduction. Inspection Trends. Electronic Records Life Cycle. MHRA Definitions. Electronic Records Governance. Relevant Electronic Records Management Procedural Controls. Electronic Records Controls - Supporting Processes. Electronic Records Controls - In Storage. Electronic Records Controls - During Processing. Electronic Records Controls - While in Transit. Trustworthy Computer Systems. Electronic Records and Service Providers. Relevant Worldwide GMP Regulations and Guidelines. MHRA Guidance. Electronic Records Management - 21 CFR Part 211. Electronic Records Management - EMA Annex 11. Self Inspection. Summary. Appendices: Glossary of Terms. Abbreviations and Acronyms. Regulatory Cross Match. MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015. Relevant Worldwide GCP and GLP Regulations and Guidelines. Electronic Records Integrity in Non-Clinical Laboratories. Electronic Records Integrity in Clinical Systems. Electronic Integrity in a Data Warehouse and Business Intelligence.