Quality Assurance and Quality Control
The staff in our Quality Assurance (QA) and Quality Control (QC) department works independently of the clinical staff involved directly in the study conduct. The QA´s and QC´s supervise all processes in all our studies, the main responsibilities are: maintenance and updates of the SOP system, which includes assisting in SOP preparation and archiving, monitoring the template and design, tracking the review versions and revision process as well as monitoring the compliance with the international quality standards.
In addition, the QA Manager is responsible for independent internal on-site checks & audits during study preparation (review of source documents, study flow charts, ordered study materials etc.) and during the study conduct (performance of safety measurements, sample collections etc.). In cases of external vendors, the QA manager takes the responsibility for auditing their qualifications.
Finally, the QA Manager is directly involved in preparation and support of external audits and inspections by clients and regulatory agencies and is responsible for preparation of corresponding responses.