The QM software for the
healthcare sector
- Control documents according to standards
- Simple process automation
- Easy operation & secure access
The QM solution for the healthcare sector
An excerpt of the practices that are already successfully using roXtra
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roXtra supports you with the following solutions:
Quality management software in hospitals
A hospital is a healthcare center where patients trust that all processes will run smoothly and that medical care will be provided optimally. In order to guarantee this patient orientation and safety as well as a high quality of treatment, reliable quality management (QM) tailored to internal hospital processes is essential. QM in healthcare is an ongoing process that requires systematic and continuous evaluation. It serves to improve the quality of products and services and helps to achieve better results.
The solution: roXtra as QM software for clinics.
We configure the system specifically to your requirements, allowing you to implement your corporate design as well as regulatory and technical requirements. Maintain an overview thanks to your individual folder structure or display the documents according to standard structures (e.g. KTQ, ISO 9001, ISO 7101, DIN EN 15224, Onkozert and DIN 6870) at the click of a mouse. The QM software for clinics also meets the requirements of the GxP-regulated environment. 🗎Here you will find an overview of how the criteria of the EU-EMP guidelines (Annex 11) and the guidelines of the German Medical Association (Rili-BÄK), for example, are implemented. The focus here is clearly on patient safety. We are also happy to support you with implementation, validation, certification and throughout the entire system operation.
With the roXtra document control you maintain an overview of your document control system in the hospital - from creation to archiving, locally and regardless of location. Regardless of whether you are in the hospital area, the institute, the medical care center (MVZ) 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 new and revised work and procedural instructions, for example, is structured, comprehensible and transparent. During certification, you can quickly and easily provide your auditor with an overview of all relevant documents and structured quality reports, 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 illustrate your processes, for example in the form of flowcharts, we offer you the Flowchart Designer, the ideal alternative to visualization programs such as Microsoft Visio. Create clear graphics to illustrate, for example, the structure of your EFQM model or critical control points that require special attention with regard to patient safety.
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 hospital. 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?
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.
- KTQ Certification: Cooperation for Transparency and Quality in the Healthcare Sector
- 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
- Requirements for operators of critical infrastructures (CRITIS)
- Claims of the Federal Joint Committee (G-BA), the German Hospital Federation e.V. (Deutsche Krankenhausgesellschaft – DKG), the German Accreditation Body GmbH (DAkkS), the German Nursing Council 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 hospitals have implemented roXtra in their quality management? Do you have questions about the design of an institution's internal quality management system (QMS), the validation of computer-based systems or the requirements of KTQ, ISO 9001, ISO 13485, G-BA and Co? In our blog, we regularly inform you about topics related to the certification process, quality management, the implementation of this in the healthcare sector, as well as application examples in the hospital, in quality assurance and actions for continuous improvement.
- 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.
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