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- Support
and consulting for the development, implementation and maintenance
of an adequate Quality Management System;
- Developoment
of a Training Matrix and Training Program;
- Providing
quality related trainings;
- Consultancy for Quality
Assurance/ Quality Control activities;
- Assistance
in writing of defined written procedures (SOPs, WIs);
- Conduct
of Audits, e.g. System Audis, Vendor Audits,
Investigational
Site Audits, on electronic systems and applications used for electronic
data capture (EDC), processing, storage and
archiving;
- Quality
Control and Audits on relevant documentation, e.g. Source Documentation,
- Support
for Corrective and Preventative Actions (CAPAs) and Audit Follow-ups;
- Assisting
with compliance questions;
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Warum
sollten Unternehmen viel Zeit und Geld mit dem Aufspüren,
Definieren und Bekämpfen von Fehlern vergeuden, wenn es
möglich ist, deren Auftreten von vornherein zu verhindern?
(Philip B. Crosby)
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