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

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Where do you rank on Quality?

Where do you rank on Quality?

Outstanding quality management is the common thread among companies that are successful at avoiding regulatory issues and adept at getting to market quickly.