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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.
QEdge eliminates paper-based workflows, minimizing errors and delays by automating Out-of-specification and out-of-trend processes.
QEdge ensures real-time synchronization of OOS & OOT processes with other digital systems, allowing consistent data flow and eliminating discrepancies.
Automated workflows and alerts enable quicker response times, reducing investigation durations significantly.
By improving data integrity, QEdge simplifies the process of maintaining compliance with regulatory standards such as USFDA, WHO, and EU GMP.
Initiateout-of-specification and out-of-trend incidents via an electronic form
Automatically route OOS & OOT to the appropriate quality personnel for investigation and root cause analysis.
Identify and document CAPAs through an integrated workflow.
Conduct final reviews and approvals of investigations and CAPA actions, followed by final closure.
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.
QEdge’s automated workflows and real-time tracking reduce investigation times by 40%.
The digitized workflows enhance both the speed and accuracy of root cause analysis, resulting in a 35% improvement.
Real-time data access and tracking foster better team collaboration, improving decision-making efficiency by 30%.
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