Preclinical Quality Assurance
QPS Austria’s Quality Assurance team monitors the compliance with the generally recognized GxP requirements. This includes, amongst others, the qualification of equipment and personnel, process- and software validation as well as the maintenance of the training and document management system. GxP-relevant processes are checked and controlled by Quality Assurance and are subject to approval by the Test Facility Management.
Our Quality Assurance carries out independent audits. All our auditors therefore have an educational background in a scientific subject and several years of experience in GxP. Depending on the topic, individual processes, studies, or systems are audited. Particular attention is paid to data integrity and traceability. If animals are involved in a study, compliance with AAALAC requirements is also evaluated as part of the audit.
In case of a deviation, the CAPA process is started, and the deviation corrected by appropriate actions. To prevent the recurrence of a deviation, effective preventive actions are defined and implemented together with the responsible decision makers. This approach enables us to identify possible weaknesses of our processes and thus continuously improve them.
Quality Assurance is the point of contact for all quality-related questions, both for our customers and for our employees. We are happy to support the qualification efforts of our customers, whether by providing the desired quality-relevant information or by organizing and conducting audits.
On customer’s request, Quality Assurance accompanies all study-relevant processes from preparation of the study plan, auditing of critical processes and data to the preparation of the final study report. Upon completion of the audit activities, an audit certificate is issued upon request.
Should deviations occur during studies, despite highly qualified staff and established processes, we strive to quickly clarify the root-cause and to define suitable corrective and preventive actions. As a result, our clients appreciate our transparency and professionalism, which strengthens their confidence in the quality of our services.
Please contact us if you have any further questions about our quality management system or quality-relevant processes.
Head of Quality Assurance, QPS Austria GmbH