Yudge

Yudge is SEA Vision's Level 4 (L4) enterprise-level track and trace solution designed for pharmaceutical manufacturers, including Marketing Authorization Holders (MAH) and Contract Manufacturing Organizations (CMO). It serves as the contact point between enterprise operations and Level 5 National Regulatory Agencies, enabling pharmaceutical companies to manage serialization and track and trace compliance requirements across global markets.

The platform handles serial number management throughout the full product lifecycle — from production through rework, shipment, and distribution — storing all serialization data, events, and related information in a dedicated database. Yudge can be deployed either on-premises or in the cloud, adapting to each customer's infrastructure and security requirements.

Core Serialization Capabilities

• Self-generates or imports serial numbers from L5 files or other L4 systems during production, with generation rules and profiles that are fully configurable and reusable
• Connects directly to regulatory agencies such as EMVO and Markirovka for serial number verification and the posting of data and events
• Manages rework, shipment, and distribution events associated with serialized products beyond the production stage
• Centralizes track and trace activities across all plants, lines, warehouses, and distribution centers within a pharmaceutical company

Deployment and Integration

• Available as an on-cloud or on-premises installation, selectable based on customer infrastructure and security needs
• Supports quick installation and integration through dedicated plug-ins developed for specific markets and regulatory requirements
• Natively integrates with Yudoo, SEA Vision's 4.0 pharmaceutical software suite, enabling analysis and comparison of large volumes of collected serialization data for meaningful insights
• Forms part of SEA Vision's broader end-to-end track and trace solution covering the full cycle of pharmaceutical serialization and aggregation

Compliance and Regulatory Features

• Specifically designed for the pharmaceutical market and compliant with industry regulations
• User access management is regulated in accordance with FDA 21 CFR Part 11 and Annex 11
• All events are recorded in an audit trail file to maintain a log of all security-relevant activities
• Continuous software development follows GAMP 5 guidelines to maintain product quality and consistency
• Designed as a future-proof solution with integrable plug-ins to keep pace with evolving global track and trace regulations while supporting an easy validation process

User Interface and Scalability

• Features a modern web-based user interface accessible from any device, including smartphones, notebooks, desktop PCs, and wide smart monitors
• Built with modularity and scalability to accommodate varying organizational sizes and operational complexity

Yudge addresses the growing global demand for unique product identification in the pharmaceutical industry, providing a configurable, compliant, and scalable serialization platform suitable for multi-site pharmaceutical operations.