OpreX Quality Management System ～Cloud-based SaaS eQMS～

Easy Access to Quality Data

OpreX QMS centralizes quality data in a unified repository and makes it accessible through dashboards, reports, and configurable visualizations. Users can monitor quality performance in real time, analyze trends based on defined KPIs, and quickly identify improvement opportunities. Audit trails are recorded in a consistent and searchable format, helping teams easily provide evidence during reviews and audits.

Quality Performance Dashboard

Data Consolidation and Collaboration

OpreX QMS connects key quality processes such as deviation, investigation, CAPA, effectiveness checks, audits, complaints, supplier quality, training, and document management on a single platform. By consolidating quality data and process information, teams across functions and sites can work from the same data foundation and make more consistent, data-driven decisions.
Also, the system can easily integrate other systems, such as MES, LIMS, ERP, via ServiceNow platform.

Data Consolidation and Collaboration Process

Workflow Visualization and Standardization

OpreX QMS defines quality processes as standardized workflows and provides task-level visibility into assignments, progress, and status. Automated notifications and direct access to approval tasks help prevent missed actions and delays. Built on ServiceNow’s Now Platform, the solution also enables no-code configuration of workflows, approval rules, data fields, validation controls, and approval steps, helping organizations adapt processes while maintaining consistency and compliance.

Quality Process Management

Efficient and Controlled Document Management

OpreX QMS manages documents in a dedicated module with control over creation, revision, approval, and obsolescence. Version of histories and approval records are automatically captured to ensure traceability. Document changes can also be linked directly to training tasks, allowing organizations to align document updates with employee training and maintain complete training records on the same eQMS platform. 

Controlled Document Access

Data Management Platform for Regulatory Compliance

The cloud platform offers key compliance features like user authentication, role-based access control, electronic signatures, and audit trails. The system automatically records all user actions and data changes, ensuring full traceability. The system supports ALCOA++ principles, ensuring that all quality records are Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available, and Traceable.
Record-level audit trail and access control ensure data integrity and compliance with GxP(GMP, GLP, GCP, GQP), FDA 21 CFR Part 11, EU Annex 11, and PIC/S guidelines. The system logs audit trails in a consistent, searchable format, making it easy to present evidence during reviews and audits.
In addition, cloud-based security and high availability reduce operational costs while maintaining continuous compliance compared to on-premises systems.

Applicable Industries

・Pharmaceuticals
・Medical Devices
・Food & Beverage
・Chemicals
・Electronics
・Energy
・Automotive
・Aerospace and others