What is QMS?

Trial Interactive’s QMS solution is a validated, dedicated repository to electronically create, track, and store incidents that are being investigated by quality assurance departments, manufacturing sites, and clinical trial teams. If desired, the QMS may be enabled with quality document management and integrated with a Learning Management System or used independently.

What can the solution do?
  • Facilitates the initiation, investigation, tracking, and resolution of Quality Incidents and CAPAs.
  • Workflows and document management processes are available to author, collaborate on, and approve controlled documents for distribution, if enabled with quality document management.
  • Monitor and evaluate supplier performance, approvals, audits, and manage supplier-related issues.
  • Record, evaluate, and resolve nonconformances or deviations, including root cause analysis and impact assessments.
  • Identify, assess, and mitigate risks related to product quality, processes, or compliance through integrated risk tools.
  • Provide dashboards, KPIs, and trend analysis for decision-making and continuous improvement efforts.
  • Full 21CFR11 compliant audit trail, tracking user, incident, and workflow actions
  • Leverages configuration to support storage of over 250 file types for evidence uploaded to incidents or CAPAs.
  • Incidents, CAPAs, and Action Items are stored with consistent naming conventions based on configurable metadata essentially allowing team members to easily identify key information and other relevant information simply by viewing the document or incident name.
  • Escalate incidents to create CAPAs through a secondary workflow to ensure the root causes of quality issues are remedied
  • Team based security access to workflows/ assignments