roXtra is a document management software. In particular, it is used to implement document management workflows (creation, review, approval, labelling, distribution, updating and training of standard documents, etc.) in order to meet the requirements of a GxP-regulated quality management system.

The processed documents (typically Standard Operating Procedures (SOPs), work instructions, forms, validation plans and other QM documents) primarily serve to fulfil the requirements of a GCP-compliant (compliance with the principles of Good Clinical Practice) QM system for the conduct of clinical trials in the field of medicinal products and medical devices.

The technical responsibility for the QM system lies with the Coordination Centre for Clinical Trials (KKS) of School VI. The Research Data Management (FDM) service centre of School VI is responsible for operating the software.