Track & Trace Software Level 4 serialization| Enterprise

Yudge. An extensive set of
Level 4 capabilities.

Yudge is SEA Vision’s Level 4 Serialization Track & Trace solution, a contact point between the corporate level and the Level 5 of National Regulatory Agencies worlds.

The Level 4 serialization solution developed by SEA Vision provides an extensive set of capabilities, to enable pharmaceutical companies to manage the different requirements for Track and Trace regulatories.

Suitable for MAH and CMO companies

Communication with regulatory agencies

Serial numbers acquistition or self-generation

Quick installation and integration

Modularity and Scalability

THE SMARTEST CHOICE

A future-proof level 4 serialization solution

Yudge is the SEA Vision track and trace software solution for the company level, suitable both to MAH and CMO pharmaceutical companies.

The software can generate a serial number that is unique for each article (SKU) in an entirely configurable way through the use of re-usable rules and profiles.

The serial numbers can be self-generated, imported from other Level 4s, or imported from files provided by the regulatory agencies (Level 5).

Yudge connects to the regulatory agencies (e.g. EMVO, Markirovka) for serial numbers verification and data posting.

All data relating to the serialization are safe: the serials, the events and related information are stored in a dedicated database.

Yudge is a scalable solution that can grow with the pharmaceutical’s unique needs and with the introduction of new regulatory changes- all with a minimized impact on validation processes.

FEATURES AND COMPLIANCE

A pharma-specific L4 solution

The system is specifically designed for the pharmaceutical market, and it is compliant with the industry regulations, with user access regulated by FDA 21 CFR part 11 and annex 11. All events are registered by the software in an audit trail file to keep track of all the security-relevant activities.

The continuous Software development follows Gamp 5, to always improve products quality and consistency.

A portfolio of natively integrated solutions

One player, one vendor, one solution provider

SEA Vision provides an extensive product portfolio of natively integrated solutions. Vision, traceability and data management solutions for pharmaceutical packaging lines are developed with a common approach to obtain a seamless ecosystem.

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