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charset=\"UTF-8\">\u003C/p>\u003Carticle class=\"4ever-article\">\u003Ch2 style=\"margin-left:0;\">\u003Cspan style=\"color:rgb(15,17,21);\">\u003Cspan data-type=\"text\">Wie stellt man sicher, dass elektronische Aufzeichnungen konform und vertrauenswürdig sind?\u003C/span>\u003C/span>\u003Cmeta charset=\"UTF-8\">\u003C/h2>\u003Carticle class=\"4ever-article\">\u003Cp style=\"margin-bottom:0;margin-left:0;margin-top:0;text-align:left;text-indent:0;\">\u003Cspan style=\"color:rgb(15,17,21);font-size:20px;\">\u003Cspan data-type=\"text\">Strikte Einhaltung von Vorschriften wie GxP, CFR 21 Part 11 usw., Bereitstellung elektronischer Signaturen mit vollständiger Audit-Trail-Funktionalität, um die Rechtsgültigkeit und regulatorische Akzeptanz von elektronischen Aufzeichnungen wie F&E-Daten, Inspektionsprotokollen und Chargenproduktionsdokumenten 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charset=\"UTF-8\">\u003C/p>\u003Carticle class=\"4ever-article\">\u003Ch2 style=\"margin-left:0;\">\u003Cspan style=\"color:rgb(15,17,21);\">\u003Cspan data-type=\"text\">Wie kann die Datenkonsistenz in multizentrischen klinischen Studien sichergestellt werden?\u003C/span>\u003C/span>\u003Cmeta charset=\"UTF-8\">\u003C/h2>\u003Carticle class=\"4ever-article\">\u003Cp style=\"margin-bottom:0;margin-left:0;margin-top:0;text-align:left;text-indent:0;\">\u003Cspan style=\"color:rgb(15,17,21);font-size:20px;\">\u003Cspan data-type=\"text\">Durch einen einheitlich standardisierten elektronischen Signaturprozess wird sichergestellt, dass die von verschiedenen Studienzentren, CROs und Laboren erstellten Dokumente wie klinische Studienprotokolle, Berichte und Einverständniserklärungen nach einheitlichen Standards unterzeichnet werden, um die Datenintegrität und die Einhaltung der Studienrichtlinien zu 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charset=\"UTF-8\">\u003C/p>\u003Carticle class=\"4ever-article\">\u003Ch2 style=\"margin-left:0;\">\u003Cspan style=\"color:rgb(15,17,21);\">\u003Cspan data-type=\"text\">\u003Cstrong>Wie geht man mit häufigen behördlichen Audits um?\u003C/strong>\u003C/span>\u003C/span>\u003Cmeta charset=\"UTF-8\">\u003C/h2>\u003Carticle class=\"4ever-article\">\u003Cp style=\"margin-bottom:0;margin-left:0;margin-top:0;text-align:left;text-indent:0;\">\u003Cspan style=\"color:rgb(15,17,21);font-size:20px;\">\u003Cspan data-type=\"text\">Das System zeichnet automatisch die vollständigen Informationen der Signaturvorgänge auf, einschließlich Identität, Zeit, Aktion und alle nachfolgenden Änderungen. 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