MAESTRO QMS transforms clinical trial quality management by unifying deviation tracking, CAPA management, audit readiness, and compliance monitoring in a single integrated platform.
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.
Streamlined workflows and automated notifications reduce resolution time for protocol deviations.
Improved tracking and visibility ensure on-time completion of corrective and preventive actions.
Proactive monitoring and early risk detection prevent quality issues before they occur.
Real-time readiness assessments and centralized documentation streamline audit response.
MAESTRO QMS integrates seamlessly with other MAESTRO modules to create a comprehensive quality ecosystem:
Automatically link quality events to specific studies, sites, and patients for complete traceability and context-aware quality management.
Ensure quality documentation is automatically filed in the appropriate TMF locations with bidirectional linking between quality events and supporting documentation.
Create standardized, compliant processes for handling deviations, CAPAs, and audits with configurable approval chains and escalation paths.
Apply intelligent analysis to detect patterns in quality data, predict potential issues, and recommend preventive actions based on historical trends.
"MAESTRO QMS transformed our approach to quality management. We've reduced our deviation resolution time by 68% while improving our inspection readiness and regulatory compliance."
A mid-size biotech company with three Phase II and two Phase III oncology trials was struggling with fragmented quality processes. They were using spreadsheets to track deviations, a separate system for CAPAs, and email for audit management—resulting in delays, compliance gaps, and increased regulatory risk.
After implementing MAESTRO QMS, they established a unified quality management approach with standardized workflows for deviations, CAPAs, and audits. The system automatically tracked metrics like mean time to deviation resolution, CAPA effectiveness, and audit finding closure rates.
Within six months, their deviation backlog was eliminated, CAPA completion rates improved to 95%, and they successfully passed an FDA inspection with zero major findings. Most importantly, the quality team could focus on proactive risk management rather than reactive firefighting, leading to a 65% reduction in critical and major deviations across all studies.
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.
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