The QM solution for Medical Care Centers
- Control documents according to standards
- Simple process automation
- Easy operation & secure access
The QM solution for Medical Care Centers
An excerpt of Medical Care Centers that are already successfully using roXtra
Customer testimonialn
roXtra supports you with the following solutions:
roXtra QM Software in Medical Care Centers
The structured cooperation of physicians from different specialties poses great challenges for medical care centers. In order to be able to guarantee interdisciplinary care from a single source, a functioning Quality Management System (QMS) is essential. The main goal of Quality Management is patient-oriented process optimization. In order to implement this, a dense network of medical and organisational control and improvement actions is required. In addition to current and scientifically recognized diagnosis and therapy standards, this also includes, for example, structured standards for internal processes.
roXtra Software Solutions meet the highest demands.
The system supports you in optimizing your QM processes. The modular solutions are scalable and can be used across sites if required and individually tailored to your needs.
Our Software Solutions advance your QM system.
Different specialist areas have different requirements for QM documentation. Thanks to the flexibility of roXtra, we can offer you a solution that is both user-friendly and compliant. In doing so, roXtra fulfills the current standard requirements (e.g. ISO 9001, ISO 13485 and ISO 7101) as well as the regulations in the GxP-regulated environment. 🗎Here you will find an overview of how the requirements of regulations such as 21 CFR Part 11, the EU-EMP guidelines (Annex 11) and the guidelines of the German Medical Association (Rili-BÄK) are implemented in roXtra. We are also happy to support you during implementation, validation and throughout system operation.
With the roXtra Document Workflow you keep an overview of your documentation – from creation to archiving, locally as well as location-independent. Regardless of whether you are in the hospital, the laboratory, outpatient care, the doctor's practice or in the office, with roXtra you and your employees 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 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).
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 concise graphics and illustrate, for example, the structure of the High Level Structure (HLS), your EFQM model or critical control points that must be given special consideration by top management with regard to patient safety and hospital hygiene.
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 care center (MVZ). roXtra supports the current 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 and continuous improvement 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
- ISO 7101 Quality management systems in healthcare - Requirements
- 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 an institution has implemented roXtra in its quality management? Do you have questions about the design of a facility's internal QM system, basic requirements or the provisions of KTQ, the ISO 13485 standard, G-BA and co.? In our blog, we regularly inform you about topics related to quality management, its implementation in healthcare, as well as application examples in medical care, quality assurance and continuous improvement actions.
- 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 workflows
A 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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