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What is Quality Management System Software for Clinical Trials?

Quality Management System (QMS) software for clinical trials helps teams track and control quality-related processes during a study. It supports the management of audits, deviations, corrective actions, training, and document control. The software ensures that trials follow good clinical practice and meet regulatory requirements.

QMS software creates a central platform for logging quality events, assigning tasks, and monitoring timelines. It also stores all quality documents in one secure location with version control and audit trails. By using automated workflows, QMS software reduces manual work and helps research teams respond to quality issues faster.

 

All Quality Management System (QMS)

Top benefits of QMS software for clinical trials:

  • Centralized quality tracking: All audits, deviations, and CAPAs are managed in one system.
  • Automated workflows: Tasks and approvals are assigned and tracked automatically.
  • Improved compliance: The software supports documentation and reporting for inspections.
  • Faster issue resolution: Teams can respond to quality events with clear timelines and accountability.
  • Secure document storage: Quality records are stored with full version history and access control.
  • Real-time visibility: Managers can monitor quality metrics across sites and studies.
  • Streamlined training management: Training records and certifications are tracked for all staff.
  • Audit readiness: Built-in logs and controls help maintain a constant state of inspection readiness.

 

betterclinical showcases over 400 clinical trial software

For an infographic representation of all these software solutions, have a look at the Clinical Trial Software Landscape.

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