Quality Management System

MAESTRO QMS transforms clinical trial quality management by unifying deviation tracking, CAPA management, audit readiness, and compliance monitoring in a single integrated platform.

Quality Management System Module

Comprehensive Quality Control

MAESTRO's Quality Management System (QMS) provides a centralized platform for managing all aspects of clinical trial quality. From protocol deviations to CAPA tracking, audit management to SOP compliance, our QMS streamlines your quality processes while ensuring complete regulatory compliance.

Issue & Deviation Management

  • Centralized deviation tracking across sites
  • Configurable deviation classification system
  • Automated root cause analysis tools
  • Impact assessment workflow
  • Trend analysis and reporting

CAPA Management

  • Integrated CAPA initiation from deviations
  • Multi-step approval workflows
  • Effectiveness check scheduling
  • CAPA status tracking and escalation
  • Comprehensive audit trails

Audit & Inspection Readiness

  • Configurable audit checklists
  • Integrated audit scheduling
  • Finding tracking and resolution
  • Inspection management toolkit
  • Real-time readiness dashboards

Quality Risk Management

  • Risk assessment templates
  • Risk-based monitoring integration
  • Automated risk signals from clinical data
  • Quality tolerance limit monitoring
  • Proactive quality metrics

Document Control

  • SOP lifecycle management
  • Training tracking and certification
  • Electronic signature compliant with regulations
  • Document versioning and obsolescence
  • Controlled distribution tracking

Vendor Quality Oversight

  • Vendor qualification assessments
  • Automated vendor performance tracking
  • Quality agreement management
  • Vendor audit planning and execution
  • Integrated issue management across partners

Quality Excellence Benefits

70%

Faster Deviation Resolution

Streamlined workflows and automated notifications reduce resolution time for protocol deviations.

95%

CAPA Compliance

Improved tracking and visibility ensure on-time completion of corrective and preventive actions.

65%

Reduction in Quality Issues

Proactive monitoring and early risk detection prevent quality issues before they occur.

4x

Faster Audit Preparation

Real-time readiness assessments and centralized documentation streamline audit response.

Seamless Integration

MAESTRO QMS integrates seamlessly with other MAESTRO modules to create a comprehensive quality ecosystem:

QMS + CTMS

Automatically link quality events to specific studies, sites, and patients for complete traceability and context-aware quality management.

QMS + eTMF

Ensure quality documentation is automatically filed in the appropriate TMF locations with bidirectional linking between quality events and supporting documentation.

QMS + Workflow

Create standardized, compliant processes for handling deviations, CAPAs, and audits with configurable approval chains and escalation paths.

QMS + AI Agents

Apply intelligent analysis to detect patterns in quality data, predict potential issues, and recommend preventive actions based on historical trends.

Schedule a Demo

See how MAESTRO QMS can transform your clinical quality management. Schedule a personalized demo with our team to explore the platform's capabilities and discuss your specific needs.

Join organizations achieving faster deviation resolution, improved CAPA compliance, and inspection readiness—all while reducing quality issues across your clinical trial portfolio.

Book Your Discovery Call