
OpreX Quality Management System
A system for managing 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 accelerates digital transformation in quality assurance processes for GMP manufacturing. It facilitates the management, monitoring, and control of quality assurance workflows, including deviations, CAPAs, change controls, and document management.
Benefits
- Rapid and flexible process improvement: Offered as a SaaS no-code platform, it allows quick adaptation to business needs and integrates emerging technologies like AI through updates. It reduces IT burdens and supports efficient operations by being vendor-managed.
- Accelerate business processes: By visualizing processes, it standardizes undocumented procedures, identifies bottlenecks, and enhances information sharing, leading to improved usability and efficiency.
- Continuous improvement of business: Dashboard functionality aids in business analysis and improvement, eliminating silos and enhancing organizational cooperation.
Features
- Quick access to necessary information: A detailed search function with flexible result configuration supports efficient information management.
- Intuitive data aggregation and sharing: Simplified report creation and sharing enhance team collaboration.
- Visualization of workflow: Designed for ease of use, it improves productivity by displaying operational procedures clearly and reducing dependency on individual skills.
- Efficiency in document management: Standardized and automated document registration simplifies management, with hierarchical structures and access control based on permissions.
- Support compliance: Ensures compliance with global and pharmaceutical regulations through 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 ComplianceField(s)
Quality & Compliance
Target user(s)
QA / Regulatory AffairsIT / Systems Admin
Tag(s)
Quality & Compliance ManagementAI
