The QM Solution for your Laboratory
- Control documents according to standards
- Simple process automation
- Easy operation & secure access
The QM Solution for your Laboratory
An excerpt of our customers of the laboratory industry,
who already trust roXtra
Customer testimonialn
roXtra supports you with the following solutions:
roXtra QM Software in the laboratory area
Medical laboratories have the task of analyzing biological samples for screening, diagnostic and follow-up purposes, and also to treat and prevent diseases. The results from the analysis must not only be provided precisely, but also in a timely manner. At the same time, the traceability of laboratory procedures and the safety of patients and employees must be guaranteed. To ensure that the quality of the results obtained and services performed are officially recognized, laboratories obtain accreditation for standards such as ISO 15189 (medical laboratories), DIN 58936 and DIN EN ISO 17025 (testing and calibration laboratories).
These regulations demand a continuous increase in the quality and competence requirements of laboratories. This can only be achieved with a correctly implemented Quality Management System (QMS). The QM system is a decisive instrument for keeping the quality of the examinations, tests and calibrations carried out in the laboratory at the highest possible level at all times, for constantly improving it (CIP) and for identifying and eliminating weak points at an early stage.
roXtra solutions support you in Quality Management at the highest level.
Thanks to the flexibility of roXtra, we can offer you a solution that is both compliant and user-friendly. In doing so, roXtra fulfils the common standard specifications as well as the regulations in the GxP-regulated environment. Here you will find an overview of how the requirements of regulations such as the guidelines of the German Medical Association (Bundesärztekammer) are implemented in roXtra. Furthermore, we are happy to support you during implementation, validation and throughout the entire system operation.
With roXtra Document Workflow the management of your QM documentation (e.g. test procedures, service specifications, hygiene management etc.) is easy - and this over the entire document life cycle for all guidelines and requirements - including ISO/IEC 17025.
The Document Management System (DMS) offers your company individual workflows as well as automatic and audit-proof versioning and archiving. The review and approval of, for example, new and revised work and process instructions becomes structured, traceable and transparent. During the audit, 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).
Digitalize and automate your internal processes with the module roXtra Processes. With the graphical modelling (BPMN 2.0) you have the possibility to map and run through rules, responsibilities, tasks and input fields for different processes and forms (e.g. inspection reports, corrective actions etc.).
With the Flowchart-Designer you can visualize simple models - such as flowcharts, organigrams, mindmaps, etc. - in no time at all. This makes the processes of your laboratory (handling complaints, carrying out sampling, etc.) easy to understand for your employees and can also be used for continuous improvement (CIP).
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 of your laboratory processes. roXtra supports the current standards and regulations (e.g. ISO 22367, ISO 15189, Rili-BÄK, ISO 31000 or ONR 49001, ISO 9001 and ISO 27001).
Laboratory processes must be regularly subjected to a risk assessment. Effective risk management supports the avoidance, reduction, optimization and transfer of risks in your laboratory. Therefore, many regulations require a risk management system. In this way, you can prevent various risks (e.g. poor hygiene, equipment faults, incorrect calibration, incorrect operation of analysis equipment, etc.) and prevent them in the future.
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.
Our software solutions support you in both, daily laboratory operations and during the certification and re-certification of your Quality Management system. With roXtra, the implementation of a multitude of standards and regulations becomes a breeze.
- ISO/IEC 17025 - General requirements for the competence of testing and calibration laboratories
- ISO 15189 - Medical laboratories
- DIN 58936 - Quality management in laboratory medicine
- Rili-BÄK - Guideline of the German Medical Association for the Quality Assurance of Laboratory Medical Examinations
- Implementation of the DIN EN ISO 9000 series of standards - quality management standard
- Including DIN EN ISO 9001 - Quality management systems
- DIN EN ISO 31000 - Guidelines for risk management
- or ONR 49000 / ONR 49001 - Austrian risk management standard
- ISO 22367 - Medical laboratories - Error reduction through risk management and continuous improvement
- ISO 27001 - Information Security Management System (ISMS) / IT Security
- Guidelines of the German Medical Association (Rili-BÄK)
- 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
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 a wide variety of areas.
- Digital document control in diagnostics
The Dr. Stangassinger Institute implemented the roXtra document management system and thus not only optimized its processes in molecular diagnostics. The entire quality management system benefited from the restructuring. - From paper to bytes: a training institute relies on digital workflowsA new roXtra success story in the QZ: A training institute works with digital workflows. Everyone involved in the process benefits enormously from this.
- Flying with a system: Helvetic Airways' success through roXtra processesThe Swiss airline Helvetic Airways has been using roXtra processes for over five years to simplify business processes. The magazine "MQ - Management und Qualität" recently published a user report on this.
Experience roXtra live
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