The QM software for the
healthcare sector

Efficient quality management

With roXtra document control, you can maintain an overview of your document control system in the hospital - from creation to archiving, locally and regardless of location. Regardless of whether you are in the hospital area, the institute, the medical care center (MVZ) or in the office, with roXtra you and your employees always have access to the valid version of your documents.

The review and approval of new and revised work and process instructions, for example, is structured, comprehensible and transparent. During certification, you can quickly and easily provide your auditor with an overview of all relevant documents and structured quality reports, including important meta information (e.g. resubmission date, status and revision).

Digitally control and optimize healthcare processes

Optimize and automate your process management with the roXtra Processes module and bring your applications and forms "to life" digitally. From vacation requests, CAPA notifications and quality assurance to change management, complaint management and the implementation of continuous improvement measures - you can easily map your individual forms and processes.

To illustrate your processes, for example in the form of flowcharts, we offer you the Flowchart Designer, the ideal alternative to visualization programs such as Microsoft Visio. Create clear graphics to illustrate, for example, the structure of your EFQM model or critical control points that require special attention with regard to patient safety.

Structured risk management for clinics

With roXtra Risks reduces the amount of work required for your cross-company risk management. Identify and manage potential risks centrally for an effective, qualitative risk analysis in your hospital. roXtra supports the current standards and regulations (e.g. ISO 31000 and ONR 49001, ISO 15224, ISO 9001 and ISO 27001 / IEC 8001).

Patient safety is the top priority in the healthcare sector. Risks cannot be completely eliminated - but effective risk management helps to avoid, reduce, optimize and transfer risks. Many regulations therefore require a risk management system to support ongoing operations. This allows you to prevent and avoid clinical risks (e.g. poor hygiene, mix-ups, misdiagnosis, etc.) as well as non-clinical, business risks (e.g. loss of customers and therefore financial risk) in the future.

Professionally managing audits in the healthcare sector

Audits are an essential part of your work as a quality manager and internal auditor?
Systematic audit management is your most powerful tool as an auditor!

Increase the effectiveness and quality of your own work with the roXtra Audits module. The software supports you in auditing management systems in accordance with specifications such as ISO 19011.

Thanks to roXtra Audits , you can work systematically and access the questionnaire for conducting audits from any location, even offline. This allows you to increase internal efficiency and accuracy when conducting audits. At the same time, you and your team gain an overview of the status of past, current or planned audits.
Concentrate on identifying internal non-conformities and potential for improvement. Defined immediate, corrective and preventive measures are documented and initiated directly in the context of the audit. Whether DIN EN ISO 9001, ISO 13485, DIN EN ISO/IEC 17025 or ISO 14001: roXtra helps you to meet the various requirements of current standards with flying colors in order to do a really good job.

Action management in clinics

Effective action management with roXtra Actions is essential in hospitals to eliminate deviations, minimize risks and meet the requirements of standards such as ISO 9001, DIN EN 15224 and ISO 31000. With a structured approach, immediate, corrective and preventive actions (CAPA) can be efficiently planned, implemented and tracked.

A digitally supported system ensures complete documentation and transparent monitoring of all measures, thereby increasing patient safety, promoting continuous improvement and ensuring compliance with legal and regulatory requirements.

Your advantages with roXtra Actions:

• Cross-module: Linking for consistent documentation.
• Central management: Clearly record and control all measures.
• Automatic effectiveness check: Sustainable implementation through planned checks.
• Simple evaluation: Filter lists of measures and export them as Excel, Word or PDF.

Support for quality management and certification in clinics

Our software solutions support you in daily system operation as well as during the certification and re-certification of your quality management system. With roXtra, implementing a large number of standards and regulations becomes a breeze.

Quality management standards

• DIN EN ISO 9000 and DIN EN ISO 9001 Quality management systems - Requirements
• KTQ certification: Cooperation for transparency and quality in healthcare
• DIN EN 15224 Quality management systems for healthcare
• ISO 7101 Quality management systems in healthcare - Requirements
• DIN EN ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes
• NÖ BASIS ZERT

Risk management standards

• DIN EN ISO 31000 - Guidelines for risk management
• ONR 49000 / ONR 49001 - Austrian risk management standard
• IEC 80001 standard for risk management in networked medical technology
• § Section 91 (2) AktG - Establishment of a risk management system (RMS) for listed companies

Information security management

• ISO 27001 - Information security management system (ISMS) / IT security

Specific guidelines and laws

• Requirements for operators of critical infrastructures (KRITIS)
• Claims of the Joint Federal Committee (G-BA), the German Hospital Federation (DKG), the German Accreditation Body (DAkkS), the German Nursing Council (DPR) and the Quality Medicine Initiative (IQM)
• KonTraG - Law on Control and Transparency in the Corporate Sector (Corporate Governance)

SaaS or on-premise

As a customer, you decide whether you want to use the roXtra QM software as Software-as-a-Service (SaaS) or hosted locally (on-premise). Please note that the roXtra software is developed and hosted in Germany.

Regardless of which model you choose, security is our top priority: with regular penetration tests (pentests) and security checks, we guarantee the protection of your data and aim to meet the highest security standards.

Is hosting your SaaS solution in accordance with the C5 standard of the German Federal Office for Information Security (BSI) relevant for you? Contact us to find out more.