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In today’s fast-paced, compliance-driven industries, managing Quality Management System (QMS) activities efficiently is essential to ensure regulatory adherence, operational excellence, and customer satisfaction. Arizona Automation and Technologies introduces TRackQS, an advanced software solution designed to digitize, streamline, and automate all QMS-related activities. TRackQS empowers organizations with a centralized platform to manage, monitor, and improve quality processes, ensuring operational consistency and regulatory compliance.

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Key Modules of QMS Logo Software

Deviation Management

Ensures timely identification, documentation, and resolution of deviations from standard processes.

  • Record deviations with detailed descriptions, root causes, and impact assessments.
  • Define corrective actions and assign responsibilities.
  • Automated reminders and follow-ups to close deviations promptly.
  • Comprehensive deviation tracking and reporting.

Investigation Management

Streamlines the process of conducting investigations into quality incidents, deviations, and other issues.

  • Document detailed investigation reports with evidence and findings.
  • Use guided workflows for root cause analysis (e.g., 5-Why, Fishbone diagrams, etc.....).
  • Link investigations to related CAPA and Parent records.
  • Generate investigation summary reports for audits.

CAPA (Corrective and Preventive Action)

Provides an end-to-end solution to manage CAPA processes, from identification to closure.

  • Create CAPA records with root cause analysis and corrective action plans.
  • Monitor CAPA progress through real-time dashboards.
  • Verify effectiveness of actions.
  • Integrated workflows for approval and audit readiness.

Change Control Management

Automates the tracking and management of change requests to ensure a structured and compliant change control process.

  • Capture, review, and approve changes with electronic workflows
  • Link changes to related documents, processes, and systems
  • Maintain a complete audit trail of all changes for regulatory inspections.
  • Notifications and alerts for pending approvals and deadlines.

Incident Management

The process of recording and managing quality-related incidents in manufacturing and operational workflows.

  • Log incidents with detailed descriptions and related evidence.
  • Assign corrective actions and track their completion.
  • Generate incident reports for management review.
  • Automated notifications for unresolved incidents.

Market Complaint

A comprehensive solution to manage customer complaints efficiently and ensure timely resolution.

  • Capture, categorize, and prioritize complaints.
  • Assign investigation teams and track complaint resolution.
  • Generate complaint analysis reports for continuous improvement.
  • Ensure regulatory compliance with complete traceability.

OOS (Out-of-Specification) Management

Simplifies the documentation and resolution of OOS results in laboratories and manufacturing processes.

  • Record OOS results and assign investigations.
  • Monitor OOS trends to identify recurring issues.
  • Automated escalation workflows for high-risk OOS incidents.
  • Compliance with regulatory requirements like 21 CFR Part 11.

OOT (Out-of-Trend) Management

Helps identify and resolve trends that fall outside predefined quality limits.

  • Track OOT results with real-time data analysis.
  • Conduct root cause analysis and implement corrective actions.
  • Trend monitoring and reporting for proactive issue identification.
  • Integrated with sampling and analytical systems.

why choose QMS Logo Software ?