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.
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.
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.
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.
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.
