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Dokumentation einer SOP von der Anlage bis zur Mitarbeiterschulung komplett digital

MLM Medical Labs bildet analogen Prozess in QM-Suite von Mediaform ab

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MLM Medical Labs ist ein Zentral- und Speziallabor für klinische Studien. Aus dieser Fokussierung entsteht ein hoher Anspruch, sowohl die Prozesse als auch die Ergebnisse betreffend. Daher ist das Labor nach DIN EN ISO 15189:2014 akkreditiert, GLP zertifiziert und erfüllt die GCLP Guideline. „Zur Qualität gehört unbedingt die Nachvollziehbarkeit in der Dokumentation“, sagt Nicole Jansen-Paland, Qualitätsmanagerin bei MLM Medical Labs. „Gemäß GLP müssen wir alle studienbezogenen Abläufe vollständig und gerichtsverwertbar dokumentieren sowie die Dokumentation 15 Jahre lang aufbewahren.“ Dazu gehören neben den Unterlagen zu den Studien selber auch Personal- und Geräteunterlagen sowie die Standard-Arbeitsanweisungen (Standard Operating Procedure, SOP). „Bei den
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