The independent Quality Assurance department is centrally organised at CRS-Andernach GmbH and responsible for the whole CRS Group.

The Quality Assurance department is responsible for performing audits during clinical and bioanalytical studies according to GCP, GLP, GMP and the respective legal requirements. This includes audits during planning (study protocol and related documents), performance (e.g. administration, measurements, sample collection and handling) and reporting (study report).
Furthermore the department performs system audits in-house and at external sites (e.g. the clinical laboratory).

Managing of the SOP system is another task which is under the responsibility of the Quality Assurance department.

Independently from the department Quality Assurance quality control will be performed during all steps of data handling in all departments. Therefore it is an integral part of our quality management system. All essential procedures are integrated, such as Clinical Realisation, Clinical Data Management, Bioanalytics and Medical Writing. For example study data is subject to multiple quality control reviews; each CRF file is thoroughly checked by our monitoring team to ensure accuracy, consistency and protocol adherence of the data prior to release to Clinical Data Management.