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Qualtrax doesn’t just help you meet the requirements of ISO 9001. It provides the tools needed to meet ISO 9001, ISO 13485, ISO 14001, AS9100, OSHAs 18001 standards and 21 CFR Part 11.

Let us provide you with the tools you need to meet compliance with standards. Qualtrax compliance software simplifies internal and external audits and streamlines employee training and competency management. We ensure the most recent policies and work instructions are up-to-date, automate paper processes, and drastically reduce the amount of time it takes to prepare for and complete audits.

Best in Class Pre-Populated Workflows

  • Corrective Action Report (CAR)

    Never again forget to verify the effectiveness of corrective actions.

    The Corrective Action Report workflow tracks progress from reporting possible nonconforming work to verification, implementation, and effectiveness verification. This workflow is automatically launched by the findings of an Internal Audit.

  • Internal Audit

    Streamline your internal audit process, increase accountability across audit teams, and ease audit scheduling.

    The Internal Audit process captures the assigning, auditing, and reviewing of subsequent findings which launch the Corrective Action Report (CAR) workflow. Receive all assessor notes and supporting documentation in a single location and gain consistency year over year.

  • Management Review

    Simplify the collection of evidence files for management review.

    The Management Review workflow encompasses scheduling of the annual review of the management system to include identifying areas to be examined and subsequent feedback from involved parties, closure.

  • Supplier/Vendor Evaluation & Approval

    Easily audit your external suppliers and vendors.

    The Supplier/Vendor Evaluation & Approval workflow manages requests for the evaluation of suppliers or vendors of critical consumables, supplies, and services which affect the quality of manufacturing processes and operations.

  • Customer Complaints

    Maintain and improve your customer satisfaction through consistent customer feedback collection and reporting.

    The Customer Complaints workflow tracks customer complaints from receipt through review, root cause analysis, response, and if necessary, corrective action.

Product Feature Benefits

Accreditation Management

  • Centralize your organization’s audit data
  • Reduce audit prep time
  • Ensure your compliance with standards
  • Reduce risk across your organization
  • Get reports delivered right to you

 

Document Management

  • Maintain up-to-date data across your organization
  • Manage compliance with role-based actions
  • Easily find the documents that you need in a central location
  • Minimize approval time and difficulty
  • Work with rich features that serve you

 

Process Management

  • Automate your processes like CAPAs, complaints, calibration, purchase requests and more
  • Enhance visibility of processes including gaps and bottlenecks
  • Embrace flexibility through tools and templates
  • Run reports on active and past processes
  • Engage customers, vendors, and suppliers
  • Encourage a culture of quality and improvement

 

Testing & Training

  • Make training easier and faster
  • Assign role-based trainings across your organization
  • Gain visibility and insight into performance
  • Access real-time training data
  • Prove employee effectiveness with reports