The QM solution for your Practice
- Document control according to standards
- Simple process automation
- Easy operation & secure access
The QM solution for your Practice
An excerpt of the practices that are already successfully using roXtra
Customer testimonialn
roXtra supports you with the following solutions:
roXtra QM software in the field of pharmacies
The establishment, maintenance and active use of a Quality Management system is essential, especially in healthcare. No institution can work sustainably without principles – this applies to small and large, to interdisciplinary, supra-local or interdisciplinary practices. From the family doctor, the dentist, the radiologist or the group practice: Quality Management systems play a very important role! Quality Management instruments are applied in all areas – from registration, consultation, diagnostic and therapeutic services to treatment as well as emergency, hygiene or equipment management. This contributes significantly to the success of a medical practice and creates trust between doctors and the patient.
Our Software Solutions advance your QM system.
Thanks to the flexibility of roXtra, we can offer you solutions that are both, user-friendly and compliant with regulations. In doing so, roXtra fulfils common standard requirements such as ISO 9001 as well as 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 (Rili-BÄK) are implemented in roXtra. In addition, we will be happy to support you in the implementation, the training of your users and during 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 dental practice, on a home visit, at a training course, at the medical care centre or in the office, with roXtra your employees and you always have access to the valid version of your documents. Create your individual QM manual, integrate it into your daily practice and always ensure patient safety thanks to regular quality checks.
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).
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 measures – you can easily map and execute your individual forms and processes.
To illustrate your processes, for example 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, your internal quality management, a concept for the hygiene of the medical practice or the distribution of tasks in the entire practice team.
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 medical practice. 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.
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 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.
- QEP (Quality and Development in Practices) of the Associations of Statutory Health Insurance Physicians (NASHIP) together with the Federal Association of Statutory Health Insurance Physicians
- KTQ Certification: Cooperation for Transparency and Quality in the Healthcare Sector
- European Practice Assessment (EPO)
- 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
- Claims of the Federal Joint Committee (G-BA), the German Accreditation Body GmbH (DAkkS), the German Nursing Council (Deutscher Pflegerat 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
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 different practices have implemented roXtra in their quality management? Do you have questions about the design of an internal quality management system (QMS) or the regulations of QEP, ISO 9001, G-BA and Co? In our blog we inform you regularly about topics such as ISO 9001 certification, legal requirements and QM in SHI-accredited medical care.
- In the service of patients
Together with the Rennbahnklinik, we have published a user report in "QZ - Quality and Reliability". Read the full article here. - Smart sensor solutions need smart document controlTogether with our customer Sensirion AG, we have published a case study in the trade journal MQ Management und Qualität. Read the complete article here.
- Mental health also needs processesTogether with our customer Dr. Fontheim - Mental Health, we have published a case study in the trade journal QZ Qualität und Zuverlässigkeit. Read the full article here.
Experience roXtra live
We will show you roXtra in a free and non-binding online presentation.