A best-in-class quality management
system for your team

Qualio’s eQMS is quickly and easily implemented and scales with your needs. We’re purpose-built for medical devices, pharmaceuticals, biotech, and contract service providers.

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Life sciences and healthcare organizations trust Qualio across the world.


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

  • Create a template library as the basis for your documents
  • Edit and collaborate on documents with Qualio’s simple web editor
  • Execute guided workflows for drafting, reviewing, and approving documents
  • Incorporate FDA CFR Part 11 compliant digital signatures
  • Retire documents
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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 compliance

Design Control

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

  • Integrate your systems (Jira, Azure DevOps, Asana, and more) and data via API to enable effective collaboration across teams
  • Identify gaps proactively so you can take immediate action
  • Generate release documentation with one click
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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

Audit-ready Reporting

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

  • Manage audits, suppliers, and change control across your entire business in real-time
  • 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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Learn why customers love Qualio