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The QM Solution for your Hospital

  • Control documents according to standards
  • Simple process automation
  • Easy operation & secure access

The QM Solution for your Hospital

An excerpt of the practices that are already successfully using roXtra

Customer testimonialn

References Crailsheim Hospital uses roXtra
References Klinikum Itzehoe uses roXtra
References Klinikum Altenburger Land uses roXtra
References Rheintalklinik uses roXtra
References Klinik am See uses roXtra
References Klinikum Dortmund uses roXtra
References Erzgebirgsklinikum Annaberg uses roXtra
References Klinik am Kurpark uses roXtra
References Schwarzwald-Baar Klinikum uses roXtra
References Lung Clinic Ballenstedt/ Harz
References Katholisches Klinikum Ruhrgebiet Nord uses roXtra
References Bergmannstrost Klinikum Halle uses roXtra
References Klinik am Alpenpark uses roXtra
References Kliniken Kreis Mühldorf a. Inn uses roXtra
References Elisabeth Vinzenz Verbund uses roXtra

roXtra supports you with the following solutions:

The roXtra Documents module for standard-compliant document management

Document control

The roXtra Processes module for digitizing business processes

Process Management

The roXtra Actions module for controlling and monitoring actions

Action Management

The roXtra Risks module for digital risk monitoring

Risk management

The roXtra Audits module for planning and documenting audits

Audit management

roXtra QM Software in Hospital Groups

A hospital is a center of health care: Patients trust that all processes will function properly and that everything will be geared to providing them with the best possible medical care. To ensure this patient orientation and safety as well as optimal treatment quality, Quality Management must also be absolutely reliable and aligned with internal hospital processes.

Quality Management (QM) in healthcare is an continuous process that requires systematic and permanent evaluation. QM serves to improve the quality of products and services and helps achieve better outcomes. In recent years, the healthcare sector has grown tremendously and is characterized by various innovations and product launches. In parallel, Quality Management in healthcare is also evolving and experiencing significant momentum on a global scale.

With the QM Software roXtra you get the optimal solution for your hospital.

We configure the system specifically to your requirements, allowing you to implement your corporate design as well as regulatory and technical requirements.

Maintain an overview thanks to your individual folder structure or display documents according to standard structures (e.g. KTQ, ISO 9001, DIN EN 15224, Onkozert and DIN 6870) with just one mouse click. roXtra also fulfils the requirements in the GxP-regulated environment. 🗎Here you will find an overview of how the criteria of, for example, the EU EMP Guideline (Annex 11) and the guidelines of the German Medical Association (Rili-BÄK) are implemented. The focus here is clearly on patient safety. In addition, we are happy to support you during implementation, validation, certification and throughout the entire system operation.


With the roXtra Document Workflow you keep an overview of your documentation – from creation to archiving, locally as well as location-independent. Whether you are in the hospital, in the lecture hall, in the medical care center or in the office, with roXtra you always have access to the valid version of your documents.

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

The roXtra Documents module for standard-compliant document management

Optimize and automate your process management with the module roXtra Processes and thus bring your applications and forms digitally "to life". From applications for leave, CAPA notifications, quality assurance to change management and the implementation of continuous improvement actions – you can easily map and execute your individual forms and processes.

To visualize your processes, e.g. in the form of flowcharts, we offer you with the Flowchart-Designer the ideal alternative to visualization programs such as Microsoft Visio. Create clear graphics and thereby illustrate, for example, the structure of your EFQM model or critical control points that must be given special consideration with regard to patient safety.

The roXtra Processes module for digitizing business processes

With roXtra risks you can reduce 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 common standards and regulations (e.g. ISO 31000 or ONR 49001, ISO 15224, ISO 9001 and ISO 27001 / IEC 8001).

In healthcare, patient safety is the top priority. Risks cannot be completely eliminated - but effective risk management supports the avoidance, reduction, optimization and transfer of risks. Many regulations therefore require a risk management system to support ongoing operations. In this way, you can prevent and avoid clinical risks (e.g. inadequate hygiene, mistaken procedures, incorrect diagnoses, etc.) as well as non-clinical, business risks (e.g. the loss of customers and thus a financial risk) in the future.

The roXtra Risks module for digital risk monitoring

Audits are an essential part of your work as a quality manager and internal auditor?
You know that 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 according to the specifications such as those of ISO 19011.

Thanks to roXtra Audits, you work with a system and access the questionnaire for conducting audits regardless of location, even offline. In this way, you increase internal efficiency and diligence when conducting audits. At the same time, your team and you gain an overview of the status of past, current or pre-planned audits.
Focus on identifying internal nonconformities and areas for improvement. Defined immediate, corrective and preventive actions are documented and started directly in the context of the audit. No matter 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.

The roXtra Audit module for planning and documenting audits

Our software solutions support you in daily system operation as well as during certification and re-certification of your Quality Management system. With roXtra, the implementation of a multitude of standards and regulations becomes a breeze.

  • KTQ Certification: Cooperation for Transparency and Quality in the Healthcare Sector
  • DIN EN ISO 9000 and DIN EN ISO 9001 Quality Management systems - Requirements
  • DIN EN 15224 Quality management systems for the health care sector
  • DIN EN ISO 31000 - Guidelines for risk management
  • or ONR 49000 / ONR 49001 - Austrian risk management standard
  • DIN EN ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes
  • Requirements for operators of critical infrastructures (CRITIS)
  • Claims of the Federal Joint Committee (G-BA), the German Hospital Federation e.V. (Deutsche Krankenhausgesellschaft – DKG), the German Accreditation Body GmbH (DAkkS), the German Nursing Council e.V. (DPR) as well as the Initiative Quality Medicine (IQM)
  • ISO 27001 - Information Security Management System (ISMS) / IT Security
  • or IEC 80001 standard for risk management in networked medical technology
  • KonTraG - Law on Control and Transparency in the Corporate Sector (Corporate Governance)
  • Section 91 (2) AktG - Establishment of a risk management system (RMS) for listed companies
Certification and standards at roXtra

success stories

We can tell you a lot of things...

...that's why we give our users a voice. In this way, you receive first-hand reports of experiences directly from practice. See for yourself and learn more about the use of roXtra in different areas. Would you like to learn more about how hospitals have implemented roXtra in their quality management? Do you have questions about the design of an institution's internal quality management system (QMS), the validation of computer-based systems or the requirements of KTQ, ISO 9001, ISO 13485, G-BA and Co? In our blog, we regularly inform you about topics related to the certification process, quality management, the implementation of this in the healthcare sector, as well as application examples in the hospital, in quality assurance and actions for continuous improvement.

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