Your solution for quality management in medicine

Effective document control

With roXtra document control, you can maintain an overview of your documentation in medical quality management at all times - from creation to archiving. Independent of location and always up-to-date, roXtra facilitates the structured checking and approval of documents. This ensures efficient medical quality management and transparency.

Your advantages with roXtra in the area of document control:

• Individual approval workflows: Customizable to your processes and standard requirements.
• Audit-proof versioning: automatic storage and archiving.
• Standard-compliant document management: For all directives, e.g. DIN EN 15224 or GxP.
• Rely on a future-proof software solution to make your quality management processes in medicine efficient, compliant and transparent.

Efficient and digital

Digitize and automate your internal processes with the roXtra Processes module. Thanks to graphical modeling in accordance with BPMN 2.0, you can easily define and control rules, responsibilities, tasks and input fields for various processes and forms (e.g. patient information, treatment procedures).

roXtra Processes enables efficient, compliant and digital processes - perfectly adapted to the requirements of university hospitals.

With the Flowchart Designer, you can create simple models such as flowcharts, organization charts or mind maps in no time at all and make your processes easy to understand for everyone involved.

With the Flowchart Designer, you can create simple models such as flowcharts, organization charts or mind maps in no time at all and make your processes easy to understand for everyone involved.

Advantages of process management with roXtra:

• Transparency and clarity: Visualization of complex processes such as clinical trial procedures, certification processes or quality assurance measures.
• Continuous improvement (CIP): Optimize processes and make them sustainably efficient.
• User-friendliness: Intuitive design and fast implementation of your requirements.

Risk management for university hospitals

With roXtra Risks you can reduce your risk management workload and improve your risk analysis. Identify and manage potential risks centrally to ensure the safety and quality of your medical devices. The software supports common standards and regulations, including ISO 31000 and ONR 49001, ISO 15224, ISO 9001 and ISO 27001 / IEC 8001.

Your advantages with roXtra Risks:

• Efficient risk identification: identify and analyze risks at an early stage.
• Customization: Flexibly define risk categories and valuation cycles.
• Clear control: matrices and risk reports for comprehensive reporting.
• Rapid integration of measures: derive and link measures directly.

Effective audit management

Audits are an indispensable part of your work as a quality manager and internal auditor. Systematic audit management is your most powerful tool for checking processes, uncovering non-conformities and driving improvements.

With the module roXtra Audits module, you can increase the effectiveness and quality of your work. The software supports you in carrying out and managing internal audits and auditing management systems in accordance with specifications such as ISO 19011.

Whether DIN EN ISO 9001, ISO 13485, DIN EN ISO/IEC 17025 or ISO 14001 - with roXtra Audits you can easily meet the requirements of current standards. The software helps you to identify potential for improvement, systematically plan and carry out internal audits and ensure traceability.

Your advantages with roXtra Audits:

• Efficiency and transparency: Document and initiate immediate, corrective and preventive measures directly in the context of the audit.
• Systematic implementation: Access your questionnaire from any location - even offline.
• Optimized planning: Maintain an overview of past, current and planned audits.