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Transforming Quality Management with Automated QMS Trend Reporting in QEdge

Need for Trend Report

In today’s fast-paced pharmaceutical industry, manual data collection and reporting processes are no longer sufficient to keep up with regulatory demands and internal quality objectives. Companies need a robust, automated solution to manage large volumes of quality data and generate real-time trend reports. QEdge addresses these needs by providing a centralised platform that eliminates the inefficiencies of manual reporting, improves data accuracy, and ensures compliance with stringent regulatory requirements (USFDA, EMA, WHO). 

Benefits  

Improved Efficiency

Automated trend reports reduced report generation time from weeks to minutes, allowing quality teams to focus on improvement initiatives.

Enhanced Data Accuracy

Automated integration and validation minimized manual data entry errors.



Faster Response to Quality Issues

Real-time trend analysis enabled prompt addressing of nonconformities, reducing the risk of quality deviations and audit findings.

Eliminates manual reporting

Compliance Confidence

Auditors could access both historical and real-time trend data, improving readiness for regulatory inspections and reducing compliance risks.

Process Diagram 

Centralized data collection from various quality processes (deviations, CAPAs, change controls, complaints).
Automated data consolidation and validation within QEdge.
Real-time generation of trend reports.
Customizable dashboards for monitoring KPIs and trends.
Actionable insights through advanced analytics for proactive quality issue resolution

Trend Report with QEdge 

QEdge integrates quality data from multiple sources into a centralized platform, automating the process of report generation and trend analysis. This allows the company to monitor key quality metrics in real time via customizable dashboards. The system is designed to meet global regulatory standards, providing continuous compliance monitoring and ensuring the company is always audit-ready. 

Results of Implementation

Efficiency Gains

Efficiency Gains

Report generation time decreased from weeks to minutes. 

Improved Accuracy

Improved Accuracy

Data integrity was ensured through automation, reducing errors. 

Timely Responses

Timely Responses

Real-time analysis allowed for faster identification and resolution of quality issues.

Audit Readiness

Automated reports improved regulatory compliance, reducing the risks during inspections and audits. 

 

QEdge Quality Management Software Suite

  • Quality Processes - QMS
  • Document Management - DMS
  • Training Management - TMS/ LMS
  • Product Review - APQR/ PQR
  • Vendor Qualification
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