SEA Vision Track & Trace
seavision-group.com
What it is
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.
Spec sheet
- Headquarters
- Pavia, ItalyRead 28 Sep 2026 · seavision-group.com
- Founded
- 1995Read 28 Sep 2026 · seavision-group.com
- Agency connectivity
- Yudge connects to regulatory agencies such as EMVO and Markirovka for serial number verification and data and event posting.Read 5 Oct 2026 · seavision-group.com
- Company certifications
- SEA Vision states that its management system is certified to ISO 9001:2015, UNI/PdR 125, and ISO/IEC 27001.Read 5 Oct 2026 · seavision-group.com
- Company history
- SEA Vision says its work began in 1995 with a goal of developing software for visual control of pharmaceuticals.Read 5 Oct 2026 · seavision-group.com
- Company support
- SEA Vision says its network of technical and commercial offices provides worldwide customer care services.Read 5 Oct 2026 · seavision-group.com
- Compliance and audit trail
- Yudge is designed for pharmaceuticals, regulates user access under FDA 21 CFR Part 11 and Annex 11, and records events in an audit trail; SEA Vision says its software development follows GAMP 5.Read 5 Oct 2026 · seavision-group.com
- Compliance controls
- Yudge states that user access is regulated by FDA 21 CFR Part 11 and Annex 11, and that security-relevant activities are recorded in an audit-trail file.Read 5 Oct 2026 · seavision-group.com
- Development practice
- Yudge says its continuous software development follows GAMP 5.Read 5 Oct 2026 · seavision-group.com
- Enterprise software
- Yudge is the Level 4 solution connecting the enterprise level with Level 5 national regulatory agencies.Read 5 Oct 2026 · seavision-group.com
- ERP and MES integration
- Yutrace can receive serialization configuration parameters manually or automatically from company systems such as ERP and MES through dedicated software modules.Read 5 Oct 2026 · seavision-group.com
- Hosting
- Yudge can be installed on-cloud or on-premises, according to the customer’s infrastructure and security needs.Read 5 Oct 2026 · seavision-group.com
- Hosting and interface
- Yudge can be installed on cloud or on premises, and its web-based interface is described as accessible from smartphones, notebooks, desktop PCs, and smart monitors.Read 5 Oct 2026 · seavision-group.com
- Inspection and aggregation
- Tracker checks serialized codes at runtime and supports parent-child aggregation from cartons to cases and cases to pallets.Read 5 Oct 2026 · seavision-group.com
- Intended customers
- SEA Vision identifies pharmaceutical MAH and CMO companies as suitable customers for its Level 4 solution.Read 5 Oct 2026 · seavision-group.com
- Interface
- Yudge has a web-based interface accessible from smartphones, notebooks, desktop PCs, and smart monitors.Read 5 Oct 2026 · seavision-group.com
- Line checks and aggregation
- Tracker checks serialized codes at runtime and performs parent-child aggregation from cartons to cases and cases to pallets.Read 5 Oct 2026 · seavision-group.com
- Line integration
- Yutrace exchanges serialization data between Level 4 systems and vision systems on packaging lines, and its modules can transfer information from databases, ERP, MES, and other IT systems.Read 5 Oct 2026 · seavision-group.com
- Monitoring
- SEA Vision’s serialization monitoring solution provides real-time dashboards for serial-number supply and use, plus analysis of historical data across one or more sites.Read 5 Oct 2026 · seavision-group.com
- Product scope
- SEA Vision offers a pharmaceutical Track & Trace solution covering serialization and aggregation from production-line devices through enterprise systems, with notifications to regulatory authorities.Read 5 Oct 2026 · seavision-group.com
- Production-site software
- Yutrace is the Level 3 software that exchanges serialization data with Level 4 systems and line vision systems.Read 5 Oct 2026 · seavision-group.com
- Regulatory communication
- Yudge connects to regulatory agencies, including EMVO and Markirovka, for serial verification and data and event posting.Read 5 Oct 2026 · seavision-group.com
- Reports
- Yutrace provides customizable reports covering commissioned and decommissioned serials, aggregation, disaggregation, and shipment events.Read 5 Oct 2026 · seavision-group.com
- Scope
- SEA Vision offers an end-to-end pharmaceutical serialization and aggregation solution spanning production-line levels 0–1 through enterprise level 4 and notification to regulatory-authority level 5.Read 5 Oct 2026 · seavision-group.com
- Serial number management
- Yudge, the Level 4 software, can generate or import serial numbers and manage their posting to regulatory agencies after line commissioning or decommissioning.Read 5 Oct 2026 · seavision-group.com
- Support and training
- SEA Vision offers help-desk and software-maintenance SLA plans, remote services, preventive maintenance, customer-portal access, and training at its premises, at customer sites, or remotely.Read 5 Oct 2026 · seavision-group.com
- Target users
- The complete Track & Trace solution is presented for pharmaceutical MAH, CMO, and OEM companies.Read 5 Oct 2026 · seavision-group.com
- Warehouse operations
- Yutrace supports warehouse reworking and shipment operations and can be provided with a physical reworkstation or mobile Reworkapp and Pickapp solutions.Read 5 Oct 2026 · seavision-group.com
- Workstation limits
- SEA Vision says its Track & Trace workstations are designed for manual or semi-automatic handling of small or medium production volumes.Read 5 Oct 2026 · seavision-group.com
Plans and prices
Strong points and limits
Strong points
- Connects serialization systems with regulatory agencies.
- Tracks aggregation from cartons to cases to pallets.
- Yudge offers cloud or on-premises hosting.
- Web interface supports phones and desktop computers.
- Audit trail records security-relevant activity.
Limits
- Pricing is available on request.
- Workstations target small or medium production volumes.
- The listed platforms omit Android, iOS, macOS, and Linux.
Who it suits
The solution is presented for pharmaceutical MAH, CMO, and OEM companies managing serialization across production lines and enterprise systems. Its workstation options are designed for manual or semi-automatic handling of small or medium production volumes.
Verdict
SEA Vision spans line checks, enterprise serial management, and regulatory communication, with hosting options for Yudge. Buyers should consider its workstation volume limits and request pricing and deployment details for their environment.
Where Specifiction places it
- Product Serialization Software#9 of 297.6