Comprehensive quality control.
A centralized platform for managing every aspect of clinical trial quality — from protocol deviations to CAPA tracking, audit management to SOP 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.
Faster deviation resolution
Streamlined workflows and automated notifications reduce resolution time.
CAPA compliance
Improved tracking and visibility ensure on-time completion of CAPAs.
Reduction in quality issues
Proactive monitoring and early risk detection prevent issues before they occur.
Faster audit preparation
Real-time readiness assessments streamline audit response.
Seamless integration with MAESTRO.
MAESTRO QMS connects natively with CTMS, eTMF, Workflow and AI Agents — one 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
Quality documentation is automatically filed in the appropriate TMF locations with bidirectional linking between events and supporting documents.
QMS + Workflow
Standardized, compliant processes for handling deviations, CAPAs, and audits with configurable approval chains and escalation paths.
QMS + AI Agents
Intelligent analysis to detect patterns in quality data, predict potential issues, and recommend preventive actions based on historical trends.