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OpreX Quality Management System

A cloud-based system for managing and controlling quality assurance processes in GMP manufacturing, including deviations, CAPAs, change controls, and document management.

Solution by Yokogawa Electric
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Overview

The OpreX Quality Management System is designed to enhance digital transformation in quality assurance processes for GMP manufacturing. It allows for comprehensive management, monitoring, and control of quality assurance workflows, including deviations, CAPAs, change controls, and document management.

Benefits:

  • Rapid and flexible process improvement: As a SaaS no-code platform, it enables quick responses to business needs and integrates emerging technologies like AI through platform updates. It reduces IT burdens and supports efficient operations by being managed by the vendor.
  • Accelerate business processes: By visualizing processes, it standardizes procedures and identifies bottlenecks, improving consistency and performance. It facilitates early error detection and enhances information sharing for better usability and efficiency.
  • Continuous improvement of business: The dashboard simplifies business analysis, enabling data-driven improvements. It eliminates silos and skill-dependent procedures, fostering organizational cooperation.

Features:

  • Quick access to necessary information: A detailed search function allows for efficient information retrieval, with flexible search result configurations and full-text search capabilities.
  • Intuitive data aggregation and sharing: Simplified report creation and sharing enhance accessibility and team collaboration.
  • Visualization of workflow: The system displays operational procedures clearly, improving productivity by reducing skill-dependent tasks and errors.
  • Efficiency in document management: Automated document registration and a hierarchical structure simplify management and access control.
  • Support compliance: Ensures compliance with global and pharmaceutical regulations, providing a comprehensive audit trail and reliable data management.

The system is applicable across various industries, including pharmaceuticals, medical devices, food and beverage, chemicals, electronics, energy, automotive, and aerospace.

Meta

Category
Regulatory & Quality Compliance
Field(s)
Quality & Compliance
Target user(s)
QA / Regulatory Affairs
Tag(s)
Quality & Compliance ManagementAI