Reliable quality management software for your laboratory
Reliable quality management software for your laboratory
Quality Management in the Laboratory: Structured, Reliable, and Audit-Ready
For more than 25 years, over 1,000 customers have relied on roXtra’s quality management system, which has proven its worth in day-to-day laboratory operations. Whether in clinical, research, or hospital laboratories, roXtra helps you focus on what really matters in the lab: precise results and confident decisions.
Why do demanding laboratories choose roXtra?
We have been a successful player in the market for 25 years and support numerous accredited laboratories with their quality management. We understand their needs, offer flexible scalability, and reliably map even complex laboratory structures.
Regulatory Compliance and Accreditation
roXtra helps laboratories implement ISO/IEC 17025, ISO 13485, ISO 15189, and other regulatory requirements in compliance with standards. All relevant information is organized in a structured format and can be presented in a traceable manner at any time during audits, accreditations, and recertifications.
Safety through controlled processes
Employees access only approved and up-to-date SOPs. Responsibilities are clearly defined, changes are documented in a traceable manner, and are reliably implemented in day-to-day operations. This ensures reliability in processes and safety in daily laboratory work.
Full traceability
All changes, versions, and approvals are fully documented and can be traced at any time.
This allows you to meet key requirements of ISO 17025 and provide inspectors with all relevant documentation in a structured manner.
High IT Security & Compliance
roXtra meets stringent data protection and information security requirements, including those set forth in the GDPR, ISO 27001, and BSI C5. This ensures that sensitive quality management and laboratory data are protected and reliably secured from a regulatory standpoint.
Scalable for accredited laboratories
roXtra is designed for testing, calibration, and diagnostic laboratories of all sizes.
New testing procedures, additional accreditations, or new locations can be integrated in a structured manner that complies with standards.
Modular Quality Management System
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—if desired—to 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 lab 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, laboratories can manage their quality management documentation in a centralized and traceable manner. Thanks to version control, regulated approvals, and automatic validity checks, documents are always up to date. Changes are transparently documented and can be audited at any time.
SOPs, work instructions, procedure manuals, audit records, forms, and checklists are managed digitally and in an audit-proof manner. Regular audit cycles and reminders help ensure ongoing compliance with regulatory requirements.
- Audit-proof versioning of SOPs and QM documents
- Documented approval and validity processes
- Audit trail and verifiable read receipts
- Clear responsibilities for documents and content
- Support for key requirements of ISO/IEC 17025
roXtra Processes a module for countless applications
With roXtra, laboratories can map their processes exactly as they are carried out in practice. Workflows are documented consistently, responsibilities are clearly defined, and changes are managed in a traceable manner. This creates transparency in day-to-day laboratory operations and provides assurance during audits and inspections.
Processes can be carried out with system support and automated as needed. This reduces errors, shortens processing times, and ensures that procedures comply with standards throughout the laboratory—without the need for additional standalone solutions.
- Simple, digital processing of workflows such as CAPA, complaint management, change management, nonconformity management, 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 relevant risks and develop appropriate measures based on them.
- Early detection of process and quality risks, such as hygiene issues, equipment malfunctions, incorrect calibrations, or operator errors
- Addressing all relevant compliance, quality, IT, and data protection risks
- Transparent assessment and prioritization of risks
- 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 transparently
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 in accordance with ISO/IEC 17025, ISO 15189, and many others
- Centralized and audit-proof audit documentation
- Complete audit trails
- Direct implementation of measures
- Can be performed remotely or offline
With these roXtra solutions, you’ll have your quality management firmly under control
Simple, digital document management
With roXtra, laboratories can manage their quality management documentation centrally and in a traceable manner. Documents are always kept up to date through version control, regulated approvals, and automatic validity checks. Changes are transparently documented and can be audited at any time.
SOPs, work instructions, test records, forms, and checklists are managed digitally and in an audit-proof manner. Regular audit cycles and reminders help ensure ongoing compliance with regulatory requirements.
✔️ Audit-proof versioning of SOPs and QM documents
✔️ Documented approval and validity processes
✔️ Audit trail and traceable read confirmations
✔️ Clear responsibilities for documents and content
✔️ Support for key requirements of ISO/IEC 17025
roXtra Processes a module for countless use cases
With roXtra, laboratories can map their processes exactly as they are carried out in practice. Workflows are documented consistently, responsibilities are clearly defined, and changes are managed in a traceable manner. This creates transparency in day-to-day laboratory operations and provides confidence during audits and inspections.
Processes can be executed with system support and automated as needed. This reduces errors, shortens processing times, and ensures standard-compliant workflows throughout the lab—without the need for additional standalone solutions.
✔️ Simple, digital handling of processes such as CAPA, complaint management, leave requests, change management, deviation management, 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.
✔️ Early detection of process and quality risks such as hygiene deficiencies, equipment malfunctions, incorrect calibrations, or operator errors
✔️ Addressing all relevant compliance, quality, IT, and data protection risks
✔️ Transparent assessment and prioritization of risks
✔️ Direct identification 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 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
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 in accordance with ISO/IEC 17025, ISO 15189, and many more standards.
✔️ Centralized and audit-proof documentation
✔️ Complete audit trails
✔️ Direct derivation of corrective actions
✔️ Can be performed remotely and offline
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.
Customer Reviews and Experiences with roXtra
Customer Stories
Digital quality management at the laboratory service provider
TRIGA-S Scientific Solutions
Answers to your most important questions
What is the aim of a QM system according to ISO/IEC 17025?
ISO/IEC 17025 specifies the requirements for quality management systems in testing and calibration laboratories. Its central objective is to ensure technical competence and the reliability of results. A QM system in accordance with this standard is intended to ensure that laboratories apply validated procedures, take measurement uncertainties into account and maintain standard-compliant documentation.
The standard also promotes continuous improvement, transparency and compliance with legal and regulatory requirements. Structured quality management increases the trustworthiness of test and measurement results, which is essential for customers, authorities and accreditation bodies.
Does roXtra meet the requirements of ISO/IEC 17025 for laboratories?
Yes. roXtra supports the standards-compliant implementation of key requirements of ISO/IEC 17025, particularly in the areas of document control, traceability, audit trails, and action tracking. The software is designed to reliably support accredited laboratories during internal and external audits.
Is roXtra suitable for accredited testing and calibration laboratories?
Yes. roXtra is used by testing, calibration, and diagnostic laboratories and is designed to meet the specific requirements of accredited laboratory environments, including audit-proof documentation, clear lines of responsibility, and full traceability.
How does roXtra support document control in the laboratory?
roXtra enables centralized, digital management of all quality management documents. Versions, approvals, validity periods, and changes are automatically documented. Employees can access the most recently approved documents at any time.
Are changes to SOPs and work instructions fully traceable?
Yes. Every change made to documents in roXtra is documented with a timestamp, the person responsible, and the version. Previous versions are retained in an audit-proof manner and can be viewed at any time.
How does roXtra support laboratories during audits and inspections?
roXtra supports the planning, execution, and follow-up of audits. Audit findings are recorded in a structured manner and directly translated into corrective actions. The processing status remains transparent at all times.
Can actions be derived directly from deviations and tracked?
Yes. Deviations and audit findings can be directly converted into corrective actions. Responsibilities, deadlines, and progress are documented centrally and tracked comprehensively.
Is roXtra also suitable for complex laboratory setups?
Yes. roXtra can accommodate different roles, responsibilities, and laboratory departments. The system is suitable for both individual locations and larger laboratory organizations with multiple departments.
How complex is it to implement quality management software in a laboratory?
The implementation of roXtra is structured and practical. Existing documentation can be imported, and the system is adapted to existing processes. Training requirements and the transition period remain manageable.
Can roXtra be used as a cloud-based or on-premises solution?
Yes. roXtra is available both as a cloud solution (SaaS) and as an on-premises system. This allows for individual IT, data protection, and compliance requirements to be accommodated.
Does roXtra meet the relevant data protection and IT security requirements?
Yes. roXtra meets strict data protection and information security standards, including those set forth in the GDPR and BSI-C5. Sensitive quality management and laboratory data are processed and stored securely.
How do you record and analyze errors and deviations in the laboratory?
Errors and deviations in the laboratory must be systematically recorded, analyzed and corrected. QM software with action management facilitates this process by documenting deviations, analyzing causes and providing automatic workflows for corrective and preventive actions (CAPA).
Digital tools ensure transparent tracking, deadline control and complete documentation - essential for audits and certifications. Software-supported deviation management improves efficiency, compliance and quality assurance in the laboratory.
Which software or digital tools can improve quality management in the laboratory?
Modern software solutions facilitate quality management in the laboratory by automating processes, simplifying documentation and ensuring compliance with standards such as ISO 15189 or ISO/IEC 17025. Document management systems (DMS) support the versioning and approval of SOPs, while action management tools record deviations, analyze causes and control CAPA processes.
In addition, laboratory information and management systems (LIMS) improve the traceability of samples and results. Audit and training software helps to document evidence and meet certification requirements. The digitalization of quality management significantly increases efficiency, traceability and compliance in the laboratory.
Why roXtra?
Over 25 years of experience
User-friendly and intuitive to use
Modular design, all in one system
Mapping complex structures with ease
Schedule an appointment online
We’ll show you roXtra—free of charge and with no obligation
Take a hands-on look at our system and visit
to find out if roXtra is the right software for your laboratory quality management.
Would you prefer to send us an inquiry? Then you've come to the right place.