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GUDI – Global UDI Management

The central solution for your UDI compliance. Directly in SAP. No interface chaos. Centralize master data in the Global Master and submit via Plug-ins to EUDAMED, FDA, NMPA & Co. Validated, secure, and fully integrated into SAP.

What is GUDI?

GUDI is the SAP Add-on that turns your ERP into the "Single Source of Truth" for regulatory submissions.

  • Native SAP Integration: No middleware, no Excel chaos.
  • Master Principle: Maintain once, use globally.
  • Validation: Business Rules Check before submission.
  • Modular: Plug-ins for EU, USA, China, Turkey, and more.
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Benefits for IT & Business

Combines compliance security with IT stability.

  • Data Integrity: No manual transmission errors.
  • Audit Trail: Complete history directly in SAP.
  • Efficiency: Mass maintenance and data inheritance.
  • Investment Protection: Ready for S/4HANA.
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Packages & Scaling

Transparent based on the number of authority plug-ins. The Global Master is included.

Market Entry

1 Plug-in

Ideal for starting in one target market.

On Request
  • Included: Global UDI Master
  • Scope: 1 active authority plug-in
  • Feature: Excel Import Template
  • Feature: Standard Validation
Global Player

2 Plug-ins

Leverage synergies (e.g., EU + USA).

On Request
  • Included: Global UDI Master
  • Scope: 2 active authority plug-ins
  • Benefit: No duplicate maintenance
  • Support: Extended Support
World Class

3+ Plug-ins

For global rollouts & governance.

On Request
  • Scope: Unlimited plug-ins
  • Governance: Department control
  • Option: Submission Gateway
  • Setup: Enterprise Support
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Note: Prices depend on plug-in combinations.

Customers who trust us

seca GmbH Carl Zeiss AG Vita Zahnfabrik Hager & Meisinger Medacta AG EDENTA Davis Schottlander Bernhard Förster MAQUET seca GmbH Carl Zeiss AG Vita Zahnfabrik Hager & Meisinger

Available Plug-ins

Choose your target markets. The logic remains the same: Common data in the Master, specific data in the Plug-in.

EU

EUDAMED

MDR/IVDR Compliance. Basic UDI-DI & UDI-DI Management.

EU

EUDAMED Vigilance

Automated MIR Reports.

US

FDA GUDID

UDI Submission Class I, II, III incl. GMN Management.

US

FDA eMDR

Automated eMDR Reports.

CN

NMPA (China)

Specific requirements for the Chinese market.

AUS

TGA (Australia)

Specific requirements for the Australian market.

SA

SFDA (Saudi)

Connection to the Saudi Food & Drug Authority Registry.

TR

ÜTS (Turkey)

Product Tracking System Notifications (Turkey).

FAQ

What do I maintain in the Master, what in the Plug-in?
In the Master, you maintain "Common Data". Only authority-specific fields are maintained in the Plug-in. No duplicate maintenance.
How is the package calculated?
Based on the number of active plug-ins and productive SAP systems. Roadmap items do not count.
Is validation integrated?
Yes, GUDI checks against official rules (e.g., FDA/EUDAMED XSD) before data leaves SAP.
Does GUDI run on S/4HANA?
Yes, natively on SAP S/4HANA and compatible with SAP ECC 6.0.
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Request Demo / Quote

Configure your interest. We will get back to you with a proposal.