Quality management software that makes day-to-day hospital operations noticeably easier
Quality management software that makes day-to-day hospital operations noticeably easier
The Quality Management System for the Healthcare Sector
Over 1,000 hospitals, hospital groups, university hospitals, and rehabilitation networks—as well as more than 4,000 healthcare facilities—rely on roXtra software—because quality in healthcare makes a difference. With over 25 years of experience, we are one of the leading tools for digital quality management in day-to-day hospital operations.
Why is roXtra the best quality management software for your hospital?
We have been successful in the market for 25 years and serve many clients in the healthcare sector. We understand your needs and are tailored precisely to them—while remaining fully scalable. Perfect for complex organizational structures.
Greater Efficiency in Hospital Operations
Digital document management significantly reduces the team’s workload: fewer piles of paper, less searching, and less chaos. Automated workflows ensure that information reliably reaches the right place—making day-to-day hospital operations a little easier for everyone.
Patient safety comes first
With roXtra, your team always works with the most current, approved SOPs. Responsibilities are clearly defined, and changes are immediately visible—this reduces sources of error and reliably protects patients and staff.
Can be used anywhere, even offline and on the go
Flexibility is key in the day-to-day work of a nursing unit: Nurses and medical staff can easily access roXtra via a web browser or on the go using any device. And even if the Wi-Fi goes down, you can still conduct audits offline without any issues.
High IT Security & Compliance
We host roXtra exclusively in a German data center that is ISO 27001-certified and BSI C5-compliant. This means our cloud solution is GDPR-compliant from the ground up and also meets all requirements of the IT Security Act and the KRITIS Regulation—ensuring maximum security and trust.
Regulatory Compliance, GxP & Audit Readiness
roXtra ensures compliance in day-to-day hospital operations. All key standards—ISO, MDR, data protection, and more—are reliably covered. Audit trails, clear role models, secure communication, and standards-compliant archiving ensure that certifications and audits become significantly simpler and more transparent.
Modular QM System:
All solutions on a single platform
roXtra combines document control, process management, risk management, audits, and corrective actions into a single tool—with a unified interface and a transparent permissions model. This makes workflows significantly simpler, clearer, and more efficient for all users.
AI Support with roXi: Less Effort, Faster Results
Our platform is a forward-looking solution that is continuously being developed. The integration of AI features helps you automate processes, perform intelligent document searches, and optimize workflows.
Schedule an appointment online now
Before we go on and on about it, we’d rather give you a firsthand look. In a free, no-obligation online presentation, we’ll introduce you to roXtra—and show you how it can make your daily clinic routine easier.
Schedule an appointment online now
Before we go on and on about it, we’d rather give you a firsthand look. In a free, no-obligation online presentation, we’ll introduce you to roXtra—and show you how it can make your daily clinic routine easier.
With these roXtra solutions, you’ll have your quality management firmly under control
Simple, digital document management
With roXtra, clinics can keep a secure overview of all documents: from versioning, approvals, and read receipts to automatic validity checks. Manage all policies, SOPs, procedure manuals, hygiene plans, work instructions, and checklists entirely digitally and without paper clutter—all while ensuring audit-proof compliance and transparency. Follow-ups and reminders ensure that content is reviewed regularly and always up to date.
- Digital, automated workflows
- Ease of use
- Automatic versioning
- Audit trail and extended read receipts
- Transparency and clear lines of responsibility
roXtra Processes a module for countless clinical applications
Whether during patient admission, surgical planning, or for internal approvals: With roXtra Processes , you roXtra Processes workflows exactly as your team works, easily model them, and automate their management. Easy to use and customizable at any time—without the need for expensive add-on modules.
- Simple, digital processing of workflows such as CAPA, complaint management, hygiene checks, surgical approvals, vacation requests, etc.
- Graphical Process Modeling with BPMN 2.0
- Integration with ERP/CRM/Office
- Electronic forms & automated workflows
- Fully digital process chains
New: AI Process Generator
Our AI generates complete BPMN processes at the click of a button. Describe your workflow or enter an existing process description, and roXi will generate logical workflows, including fields and roles.
Successfully Managing Risks, Audits, and Measures
Risk management that provides clarity
Using a centralized tool, you can identify and assess all risks relevant to the clinic and develop appropriate measures based on your findings.
- Maintaining and improving patient safety, e.g., by preventing medical errors
- Coverage of all compliance, medical, IT, and data protection risks (including ISO 31000 and KRITIS)
- Improved quality of care through early detection of process gaps
- Direct derivation of opportunities and actions from the risk management system
Plan measures easily and implement them sustainably
Clearly assign tasks, set deadlines, and track progress in real time.
- Centralized tracking and management of all measures
- Creating (CAPA) actions directly from the Processes/Risks/Audits modules
- Automatic validity checks, reports (Excel/Word/PDF), and comprehensive documentation
- Assign responsibilities for wards, departments, and divisions in a transparent manner
Is your next audit coming up? No problem.
roXtra makes your audit management clear and simple, so you're always prepared for audits.
- Compliant with ISO 9001, ISO 13485, DIN EN ISO/IEC 17025, ISO 14001, KTQ, G-BA, etc.
- GxP-compliant shipping and validation support
- Can be performed remotely or offline
- Complete audit trails
- Direct implementation of measures
With these roXtra solutions, you’ll have your quality management firmly under control
Simple, digital document management
With roXtra, clinics can keep a secure overview of all documents: from versioning, approvals, and read receipts to automatic validity checks. Manage all policies, SOPs, procedure manuals, hygiene plans, work instructions, and checklists entirely digitally and without paper clutter—all while ensuring audit-proof compliance and transparency. Follow-ups and reminders ensure that content is reviewed regularly and always up to date.
✔️ Digital, automated workflows
✔️ Ease of use
✔️ Automatic versioning
✔️ Audit trail and advanced read receipts
✔️ Transparency and clear accountability
roXtra Processes a module for countless clinical applications
Whether during patient admission, surgical planning, or for internal approvals: With roXtra Processes , you roXtra Processes workflows exactly as your team works, easily model them, and automate their management. Easy to use and customizable at any time—without the need for expensive add-on modules.
✔️ Simple, digital handling of processes such as CAPA, complaint management, hygiene checks, surgical approvals, vacation requests, etc.
✔️ Graphical process modeling with BPMN 2.0
✔️ Integration with ERP/CRM/Office
✔️ Electronic forms & automated workflows
✔️ Fully digital process chains
New: AI Process Generator
Our AI generates complete BPMN processes at the click of a button. Describe your workflow or enter an existing process description, and roXi will generate logical workflows, including fields and roles.
Successfully Managing Risks, Audits, and Measures
Risk management that provides clarity
Using a centralized tool, you can identify and assess all risks relevant to the clinic and develop appropriate measures based on your findings.
✔️ Maintaining and improving patient safety, e.g., by preventing medical errors
✔️ Addressing all compliance, medical, IT, and data protection risks (including ISO 31000 and KRITIS)
✔️ Improving the quality of care through early detection of process gaps
✔️ Directly identifying opportunities and actions based on the risk management system
Plan measures easily and implement them sustainably
Clearly assign tasks, set deadlines, and track progress in real time.
✔️ Centralized recording and management of all actions
✔️ Creation of (CAPA) actions directly from the Processes/Risks/Audits modules
✔️ Automatic effectiveness checks, reports (Excel/Word/PDF), and comprehensive documentation
✔️ Transparent assignment of responsibilities for wards, departments, and divisions
Is your next audit coming up? No problem.
roXtra makes your audit management clear and simple, so you're always prepared for audits.
✔️ Audit-ready for ISO 9001, ISO 13485, DIN EN ISO/IEC 17025, ISO 14001, KTQ, G-BA, etc.
✔️ GxP-compliant delivery and validation support
✔️ Can be performed remotely and offline
✔️ Complete audit trails
✔️ Direct derivation of corrective actions
Find out more about the AI possibilities in roXtra
roXtra opens up new possibilities for you: Thanks to our intelligent assistant roXi, you can find exactly the information you need in no time. Or use the AI Hub and an API interface to easily and securely integrate your own AI systems into roXtra—always up to date and always compliant with data protection regulations. Our team would be happy to show you in a personalized online session how you can take your quality management to the next level by leveraging artificial intelligence in roXtra.
Did you know?
roXtra is already in use at more than two-thirds of German university hospitals
Customer Reviews and Experiences with roXtra
Customer Stories
Answers to your most important questions
Which QM software is best suited for clinics?
The best QM software for the healthcare sector—especially for hospitals—is a solution that complies with all legal regulations and relevant standards in the healthcare system, fully addresses IT security and data protection guidelines, and is user-friendly for all employees. Scalability and support for remote and offline scenarios are also important to maintain flexibility. Ideally, you should choose a platform that consolidates all QM processes into a single system, thereby significantly simplifying your quality management in day-to-day hospital operations.
Which certifications and standards does the roXtra QM system support?
With roXtra, you can meet all relevant requirements.
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)
Is your certification not listed here? Feel free to contact us. We’ll find a solution for you.
Where is the roXtra QM system hosted?
As a customer, you decide whether you want to use the roXtra QM software as Software-as-a-Service (SaaS) or hosted locally at your site (on-premise). The software itself is developed and hosted in Germany. You can find all the information about your usage options here.
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 Federal Office for Information Security (BSI) relevant to you?Contact us to learn more.
Who our healthcare QM software is particularly suited for
Hospitals & Hospital Networks
Medical care centers & outpatient facilities
Laboratories & Diagnostic Centers
Rehabilitation and Nursing Facilities
Schedule an appointment online
We’ll show you roXtra—free of charge and with no obligation
Take a practical look at our system and visit
to find out if roXtra is the right software for your hospital’s quality management.
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