QA-System

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QA-System bietet im Rahmen von GxP mit Fokus auf Good Clinical Practice (GCP) und die damit verbundenen Schnittstellen zu GCP, GCLP, GVP folgende Serviceleistungen an: - Durchführung von GCP Audits, wie Investigator Site Audits, Document Audits, TMF Audits, Mock Inspection Audits, Vendor Qualification Audits etc. - Management von Audit Programmen im Auftrag von Kunden - Beratung im Bereich Quality Assurance - Unterstützung in der Implementierung und Etablierung bzw. Ausbau des Quality Management Systems - Umsetzung und Follow-up von Corrective and Preventive Actions (CAPAs) - CAPA Management

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