The QM Solution for your Laboratory

The QM Solution for your Laboratory

  • Document control according to standards
  • Simple process automation
  • Easy operation & secure access
  • Document control according to standards
  • Simple process automation
  • Easy operation & secure access

An excerpt of our customers of the laboratory industry,

who already trust roXtra

Customer testimonials

roXtra supports you with the following solutions:

Document Workflow

  • Consistent, standard-compliant documentation
  • Transparent workflows
  • Clear responsibilities
  • Automatic revision & archiving
  • Complete traceability

Process Management

  • Process modeling according to BPMN 2.0
  • Automate processes
  • Individual input forms
  • Overview of operations & tasks
  • Efficient teamwork

Contract Management

  • Administration of contracts
  • Reminder of deadlines & tasks
  • Cost overview
  • Evaluation and statistics
  • Disclosure of optimization potential

Risk Management

  • Record & analyze risks
  • Concise risk matrix: Simple or multidimensional
  • Individual evaluation cycle
  • Create & export risk reports
  • Define, create & link measures

Document Workflow

  • Consistent, standard-compliant documentation
  • Transparent workflows
  • Clear responsibilities
  • Automatic revision & archiving
  • Complete traceability

Process Management

  • Process modeling according to BPMN 2.0
  • Automate processes
  • Individual input forms
  • Overview of operations & tasks
  • Efficient teamwork

Contract Management

  • Administration of contracts
  • Reminder of deadlines & tasks
  • Cost overview
  • Evaluation and statistics
  • Disclosure of optimization potential

Risk Management

  • Record & analyze risks
  • Concise risk matrix: Simple or multidimensional
  • Individual evaluation cycle
  • Create & export risk reports
  • Define, create & link measures

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.

DOCUMENTS

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).

PROCESSES

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).

RISKS

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.

CERTIFICATION & STANDARDS

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.

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