Europe IT Consulting GmbH

# 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.

View Pricing Plug-ins

## 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
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## 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.
Ask a Question

## Request Demo / Quote

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

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