The #1 rated quality management software to unite your team, data and processes

See why Qualio's cloud-based QMS is rated #1 easiest to use, trusted by hundreds of experts in over 80 countries, and scalable with your company. We’re purpose-built for medical devices, pharmaceuticals, biotech, and contract service providers.

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Life sciences and healthcare organizations across the world trust Qualio.

Document Management

With Qualio’s secure and cloud-based system, paper files, folders, and spreadsheets become a thing of the past.

  • Create a template library as the basis for your documents.
  • Execute guided workflows for drafting, reviewing, and approving documents.
  • Incorporate FDA CFR Part 11 compliant digital signatures.

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Risk Management

Prevent potential risks early and mitigate risk easily with easy risk management that complies with ISO 13485 and ISO 14971.

  • See risk vulnerabilities across your entire organization.
  • Link risks to your product development design controls and documentation to proactively identify potential risks.
  • Ensure your quality and product teams are aligned on risk activities and vulnerabilities.

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Design Controls

Qualio’s Design Control accelerates medical device product development by uniting your systems and data in one place.

  • Integrate your systems (Jira, Azure DevOps, etc.) and data via APIs to enable effective collaboration across teams.
  • Maintain end-to-end traceability across systems in real time.
  • Generate release documentation with one click.

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Training Management

Track training activity across your company within one platform. 

  • Assign training based on roles and responsibilities, including in-line assignments. 
  • Report on training to identify and mitigate gaps and overdue assessments.
  • Create training assessments to maintain quality standards and comply with 21 CFR Part 11. 

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Audit-ready Reporting

Seamlessly generate reports on activity across your system and your users.

  • Generate detailed reporting on training, overdue and completed activities, audit trails, and change control.
  • Set periodic review cadences to conform to FDA/ISO requirements.
  • Enable closed-loop quality within your company with end-to-end traceability.

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Events

With Events, manage pre-defined actions and responses and track in accordance with regulatory requirements.

  • Capture quality events like non-conformances, deviations, and customer complaints.
  • Assign CAPA-related tasks to your team and track progress through to completion.
  • View trends in real-time and proactively identify resolutions.

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Change Control

Qualio’s change control software allows you to manage any change easily and effectively, ensuring compliance and audit readiness.

  • Document, review, and approve changes on documents, templates, Design Controls artifacts - in one system.
  • Connect your team’s tech stack via API (Jira, TestRails, etc) and run change control on artifacts from those systems directly in Qualio.
  • Get an export of change documents and change logs throughout your quality system.

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Learn why customers love Qualio