b+b trace UDI Software vs SEA Vision Track & Trace

b+b trace UDI Software provides serialization for medical devices to support Medical Device Regulation implementation at level 3. Users can create, edit, and import work or process orders, then report traceability information to multiple markets, customers, and databases. Modules cover user and rights management, audit trails, customer and target-market records, items, lines, interfaces, and label layouts. Site management includes aggregation hierarchy management, reworking, sampling, and optional serial-number management. A multipack manager can combine items across GTINs and aggregate them under a new serial number. Interfaces connect with a customer’s ERP system and with Level 5 of EUDAMED. The line manager is described as a Level 2 component for parameterizing and controlling line components. The SiteServer can run on-premise or in the cloud, using a Windows VM and MS SQL Server database supplied by the customer. Pricing is on request. Tailored support contracts are available; SLA customers receive priority support and free software updates while the SLA remains valid.

SEA Vision Track & Trace covers pharmaceutical serialization and aggregation from production-line systems through enterprise software, with notifications to regulatory authorities. SEA Vision presents the complete solution for pharmaceutical marketing authorization holders, contract manufacturers, and equipment makers. Yudge is the Level 4 software: it can generate or import serial numbers, manage their submission after line commissioning or decommissioning, and connect with agencies such as EMVO and Markirovka for verification and data or event posting. Yutrace, at Level 3, exchanges serialization information between enterprise systems and packaging-line vision systems. Its modules can transfer information from databases, ERP, MES, and other IT systems. Tracker checks serialized codes during operation and supports aggregation from cartons to cases and cases to pallets. Yutrace also supports warehouse reworking and shipment operations, with reports for serial and shipment events. Yudge can run in the cloud or on premises and provides a web interface accessible from smartphones, notebooks, desktop PCs, and smart monitors. It records security-related activity in an audit trail and regulates access under FDA 21 CFR Part 11 and Annex 11. Pricing is on request.