Greater Transparency in the Global Submission Portal: Audit Trail, UDI Publication Report and EUDAMED–swissdamed Synchronization
With the Global Submission Portal, Europe IT Consulting GmbH supports medical device manufacturers in centrally preparing, validating and submitting regulatory UDI data, as well as tracking the submission status with international authorities.
With the latest enhancements, the portal has now been expanded with three important functions: an integrated Audit Trail, a UDI Publication Report and the option to structurally reuse or synchronize EUDAMED UDI data for swissdamed registration.
This provides additional transparency for Regulatory Affairs, Quality Management and project stakeholders – especially in an environment where UDI requirements in the EU, Switzerland, the USA and Australia increasingly need to be implemented and monitored in parallel.
Audit Trail: Every Relevant Activity Documented in a Traceable Way
The new Audit Trail documents all relevant activities in the Global Submission Portal in a traceable and structured manner. Every action is recorded with date, time, user, authority, Primary DI, material number, action type and detailed information.
This makes it transparent at all times when data was uploaded, changed, deleted, exported or downloaded. It supports internal quality processes, facilitates the tracking of changes and creates a reliable basis for audits, internal reviews and regulatory documentation requirements.
Especially in international UDI processes, this traceability is an important factor. Regulatory Affairs teams not only need to know which data has been submitted to which authority, but also when changes were made, by whom they were performed and which datasets were affected.
Using flexible filter functions, audit entries can be searched specifically by time period, user, Primary DI, material number, authority or action. In addition, compact key figures provide a quick overview of audit events, active users, affected materials and performed actions.
If required, the Audit Trail can be exported and is therefore also available for internal documentation, quality management processes or external audits.
UDI Publication Report: Centrally Monitor Publication Status
The new UDI Publication Report shows at a glance which UDI data has already been published by the respective authorities and where publication gaps still exist.
For each material or Primary DI, it is transparently displayed whether the data has already been published in EUDAMED, swissdamed, TGA AusUDID or FDA GUDID. This gives companies a central overview of the global publication status of their UDI data.
Compact key figures show, among other things, the number of managed UDI materials, the current publication coverage, the licensed authorities and existing publication gaps. Using filter functions, published datasets, open gaps or specific materials can be reviewed in a targeted way.
The report supports Regulatory Affairs, Quality Management and project stakeholders in better monitoring international UDI obligations and identifying open registration or publication steps at an early stage.
This transparency can be decisive, especially for larger product portfolios. When several authorities, different deadlines, various data models and numerous product variants need to be managed in parallel, purely manual tracking is often no longer sufficient. The UDI Publication Report helps to systematically make gaps visible and derive priorities in a targeted way.
Use EUDAMED UDI Data Structurally for swissdamed
Another important enhancement concerns the structured reuse of EUDAMED UDI data for swissdamed.
Many manufacturers already maintain their UDI data for EUDAMED or are preparing corresponding datasets. At the same time, Switzerland-specific requirements, responsibilities and registration logic must be taken into account. The Global Submission Portal supports companies in using existing EUDAMED UDI data as a basis for swissdamed and preparing it specifically for Swiss requirements.
It is important to note that not every EUDAMED dataset necessarily has to be identically relevant for swissdamed. Companies often need the ability to specifically control which products are intended for Switzerland, which datasets should be synchronized and where Switzerland-specific additions are required.
The Global Submission Portal enables exactly this structured approach: UDI data can be managed centrally, checked according to authority-specific requirements and further processed in a controlled way for the relevant target markets. This can significantly reduce duplicate data maintenance, manual transfer errors and unclear responsibilities.
Why These Enhancements Are Important for Manufacturers
UDI compliance is no longer limited to a single authority or one specific data format. Manufacturers increasingly have to serve several regulatory systems in parallel: EUDAMED in the EU, swissdamed in Switzerland, FDA GUDID in the USA and TGA AusUDID in Australia.
In practice, similar challenges often arise:
- Which UDI data has already been submitted?
- Which datasets have been accepted or published by the authority?
- Which products are still missing in a specific market?
- Who changed which data and when?
- Which changes need to be traceable or documented internally?
- Which EUDAMED data can be reused for swissdamed?
- Which products are only relevant for specific target markets?
With the Audit Trail, UDI Publication Report and EUDAMED–swissdamed synchronization, the Global Submission Portal expands its role as a central platform for international UDI and submission processes.
More Control for Regulatory Affairs and Quality Management
The new functions create three key benefits in particular:
First, they improve transparency. Teams can centrally see which data has been processed, changed, submitted or published.
Second, they strengthen traceability. Changes and activities are systematically documented and can be exported if required.
Third, they support operational control. Open publication gaps, missing registrations or market-specific tasks become visible more quickly.
As a result, the Global Submission Portal not only helps with the technical transmission of UDI data, but also with the organizational management of global UDI processes.
Conclusion
With the integrated Audit Trail, the UDI Publication Report and the structured synchronization of EUDAMED UDI data to swissdamed, Europe IT Consulting GmbH is expanding the Global Submission Portal with key functions for transparency, traceability and international UDI management.
For medical device manufacturers, this means less manual control effort, a better overview of global publication statuses and a reliable basis for internal quality processes, audits and regulatory requirements.
The Global Submission Portal is therefore consistently evolving – from a solution for data validation and authority submission into a central platform for global UDI management.
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