Digitizing Out-of-Specification (OOS) and Out-of-Trend (OOT) Processes
By QEdge Team
Published On November 13, 2024
Need for OOS and OOT
Pharmaceutical companies face significant challenges when managing Out-of-Specification (OOS) and Out-of-Trend (OOT) processes manually. Manual handling can lead to inefficiencies such as investigation delays, a higher risk of human error, and reduced transparency. To address these issues, QEdge offers a fully integrated solution to digitize and streamline these advanced quality processes.
How it Benefits
Seamless Workflow Integration
QEdge eliminates paper-based workflows, minimising errors and delays by automating OOS and OOT processes.
Faster Investigation and Decision-Making
Automated workflows and alerts enable quicker response times, reducing investigation durations significantly.
Real-Time Data Synchronization
QEdge ensures real-time synchronisation of OOS and OOT processes with other digital systems, allowing consistent data flow and eliminating discrepancies.
Enhanced Regulatory Compliance
By improving data integrity, QEdge simplifies the process of maintaining compliance with regulatory standards such as USFDA, WHO, and EU GMP.
Process Diagram
Reduction in Investigation Time
Initiateout-of-specification and out-of-trend incidents via an electronic form
Investigation
Automatically route OOS & OOT to the appropriate quality personnel for investigation and root cause analysis.
Corrective and Preventive Actions (CAPA)
Identify and document CAPAs through an integrated workflow.
Approval and Closure
Conduct final reviews and approvals of investigations and CAPA actions, followed by final closure.
Advanced Quality Process with QEdge
Out–of-specification and Out of Trend incidents demand precise tracking and control to maintain regulatory compliance and product quality. These can be managed as separate modules to ensure that each incident is addressed individually while integrating seamlessly with your existing QMS. By choosing QEdge, by Sarjen Systems, you gain a fully integrated system where OOS and OOT data combine effortlessly with other quality metrics, automating data flow and simplifying report generation without manual intervention.
Results of Implementation
Reduction in Investigation Time
QEdge’s automated workflows and real-time tracking reduce investigation times by 40%.
Improvement in Root Cause Analysis
The digitized workflows enhance both the speed and accuracy of root cause analysis, resulting in a 35% improvement.
Increase in Collaboration Efficiency
Real-time data access and tracking foster better team collaboration, improving decision-making efficiency by 30%.
Improvement in Real-Time Monitoring and Control
Automated alerts and real-time monitoring enhance control and responsiveness to OOS and OOT incidents by 40%.
QEdge Quality Management Software Suite
Contact Us
6th Floor, Arista, 100 Feet Anand Nagar Rd, Jodhpur Village, Ahmedabad, Gujarat 380015
Phone : +91-79-66214899
Email: sarjen@sarjen.com