Quality Management System (QMS)

Key Features

1. Lab Incident Management :
QUADS™ enables efficient tracking and resolution of laboratory incidents. The system logs incidents, assigns corrective actions, and monitors progress to prevent recurrence, ensuring laboratory operations align with quality standards.

2. Deviation Management :
The module streamlines the identification, documentation, and resolution of deviations from standard procedures. It facilitates root cause analysis and ensures deviations are addressed promptly to maintain compliance and product integrity.

3. Change Control :
QUADS™ provides a structured process for managing changes to processes, equipment, or documentation. It ensures all changes are evaluated, approved, and documented, minimizing risks and maintaining regulatory compliance.

4. Corrective and Preventive Action (CAPA) :
The CAPA feature drives proactive quality management by identifying root causes of issues and implementing corrective and preventive measures.
QUADS™ tracks CAPA progress and effectiveness to ensure long-term quality improvements.

5. Out of Specification (OOS) / Out of Trend (OOT) :
QUADS™ manages OOS and OOT results with a systematic approach to investigation, documentation, and resolution. The system ensures compliance with regulatory requirements while maintaining product quality and safety.

6. Market Complaint Management :
The module facilitates efficient handling of market complaints, from logging and investigation to resolution and reporting. QUADS™ ensures timely responses and tracks trends to prevent future issues, enhancing customer satisfaction.

7. Audit Management :
QUADS™ simplifies internal and external audit processes by organizing audit schedules, checklists, and findings. The system maintains a detailed audit trail, ensuring readiness for regulatory inspections and compliance audits.

8. Training Management :
The module supports employee training by tracking training requirements, schedules, and completion status. QUADS™ ensures staff are adequately trained on quality processes, contributing to operational excellence.

9. Annual Product Quality Review (APQR) and Trend Analysis :
QUADS™ automates the preparation of APQRs and conducts trend analysis to monitor product quality over time. The system identifies patterns and potential risks, enabling data-driven quality decisions.

10. Risk Management :
The risk management feature integrates risk assessment and mitigation into quality processes. QUADS™ helps identify, evaluate, and prioritize risks, ensuring proactive measures to safeguard product quality and compliance.