Good Practices for computerised systems in regulated ‘GxP’ environments скачать в хорошем качестве

Good Practices for computerised systems in regulated ‘GxP’ environments

About the Webinar This presentation will cover Defining appropriate requirements (URS): -e-Compliance areas of concerns-User management-Audit trail-Networking-Time synchronisation Establishing efficient and effective supporting processes: User management & access control Data management-Backup & Restore Archiving & Retrieval-Disaster Recovery & Business Continuity- Periodic evaluation Conclusion and Q & A About Yves Samson Automation and system engineer, after his education in France and Germany, he joined Novartis Pharma, Basle (formerly Ciba-Geigy) in 1989 where he worked as application, project, and site engineer. He takes care of computerised system validation since 1992. In 2002, he founded the consulting company Kereon AG, Basle where he works as consultant, project supporter, auditor, and trainer. He is strongly engaged within ISPE and GAMP, being the editor of GAMP® 4 and GAMP® 5. He was an active member of the ISPE IT infrastructure SIG. Yves is also the co-founder of the French Speaking GAMP community of Practice: GAMP.fr, member of GAMP Europe Steering Committee and member of ISPE France Board.