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TRackQS (QMS)
In today’s compliance-driven and fast-paced industries, managing Quality Management System (QMS) activities efficiently is crucial for ensuring regulatory adherence, operational excellence, and customer satisfaction. Arizona Automation and Technologies presents TRackQS, an advanced digital solution designed to streamline, automate, and centralize all QMS processes. TRackQS empowers organizations to maintain operational consistency, achieve regulatory compliance, and drive continuous improvement with ease.
Key Modules
Deviation Management
Ensures prompt identification, documentation, and resolution of deviations from standard processes.
- Record deviations with detailed descriptions, root cause analysis, and impact assessments.
- Assign responsibilities and define corrective actions.
- Automated reminders and follow-ups ensure timely closure.
- Comprehensive deviation tracking and reporting for audit readiness.
Investigation Management
Simplifies investigation of quality incidents, deviations, and related issues.
- Document detailed investigation reports with supporting evidence.
- Use guided workflows for root cause analysis (e.g., 5-Why, Fishbone Diagrams).
- Link investigations to CAPA and parent records for traceability.
- Generate investigation summary reports for audits and compliance.
CAPA (Corrective and Preventive Action)
End-to-end management of CAPA processes from identification to closure.
- Create CAPA records with corrective and preventive action plans.
- Track progress through real-time dashboards.
- Verify the effectiveness of corrective actions.
- Integrated workflows for approvals, compliance, and audit readiness.
Change Control Management
Digitizes and automates the change control process for structured compliance.
- Capture, review, and approve change requests electronically.
- Link changes to impacted documents, processes, and systems.
- Maintain a complete audit trail of all changes for inspections.
- Alerts and notifications for pending approvals and deadlines.
Incident Management
Efficient recording and management of operational and quality-related incidents.
- Log incidents with detailed descriptions and evidence.
- Assign corrective actions and monitor completion status.
- Generate incident reports for management and compliance.
- Automated alerts for unresolved or overdue incidents.
Market Complaint Management
Comprehensive solution for capturing and resolving customer complaints.
- Record, categorize, and prioritize complaints.
- Assign teams for investigation and resolution tracking
- Generate complaint trend analysis for continuous improvement.
- Ensure regulatory compliance with full traceability.
OOS (Out-of-Specification) Management
Streamlines documentation and resolution of OOS results in labs and production.
- Record OOS results and initiate investigations promptly.
- Monitor OOS trends to detect recurring issues.
- Automated escalation workflows for high-risk cases.
- Fully compliant with 21 CFR Part 11 and industry standards.
OOT (Out-of-Trend) Management
Detects and addresses data or process trends that fall outside expected ranges.
- Track OOT results with real-time data analysis.
- Perform root cause analysis and implement corrective actions.
- Enable proactive monitoring through trend reports.
- Integration with sampling and analytical systems for accuracy.
Why Choose TRackQS Software?
Comprehensive Compliance
Meets global regulatory standards including ISO 9001, ISO 13485, 21 CFR Part 11, and GxP guidelines. Always audit-ready with built-in compliance features.
Real-Time Monitoring & Dashboards
Intuitive dashboards provide KPIs and analytics for actionable insights, enabling quick decision-making and continuous improvement.
Seamless Integration
Integrates smoothly with ERP, LIMS, and other enterprise systems for unified data management across platforms.
Scalability & Customization
Adaptable to organizations of all sizes with modular design for tailored solutions. Grows with your business needs.
User-Friendly Interface
An intuitive, modern interface ensures rapid adoption by quality teams, reducing the learning curve.
Paperless Quality Management
Replace manual, paper-based processes with digital workflows, electronic approvals, and secure audit trails to achieve true digital transformation.
