OVERVIEW
UDI (Unique Device Identification) regulations are becoming increasingly put into effect worldwide, with many countries implementing or planning to implement UDI systems to enhance device traceability, improve patient safety, and support regulatory oversight. There are currently over 15 countries that require or have proposed legislation for unique device identification of medical devices that are sold in their market. This can be a challenge for global manufacturers who need to keep up with country-specific UDI regulations and timelines, including data submission requirements.
Innovit’s UDI Multi-Connector simplifies data management, validation and submissions to global UDI databases. It is built to support GAMP 5 system validation standards and address 21 CFR Part 11 and Annex 11 requirements.
INNOVIT UDI MULTI-CONNECTOR
Innovit UDI Multi-Connector provides a flexible and cost-effective solution for device manufacturers and labelers to submit device data to multiple UDI databases simultaneously, including the FDA’s GUDID, EU’s EUDAMED, Australia’s AusUDID and Switzerland’s swissdamed. Manufacturers automatically get a pre-packaged list of attributes, code lists and data validation rules for each UDI database.
Innovit UDI Multi-Connector also provides machine-to-machine (M2M) connections to the regulatory databases using the specific message protocol and XML format required by the database. For example, it connects with the FDA’s GUDID using AS2/NextGen API and submits UDI data in HL7 SPL XML format, while it uses the AS4 messaging protocol and SOAP XML format for EUDAMED. It also provides full Audit Trail for changes to your device data, and an eSignature capability for workflow approvals in compliance with 21 CFR Part 11 and Annex 11 requirements. Finally, it provides a message log that presents a full message exchange history with the relevant UDI database, thereby giving you clear visibility to your data submission history.
BENEFITS
Achieve timely UDI compliance globally
Use a single solution to meet global UDI submission requirements including to the GUDID, EUDAMED, AusUDID, swissdamed and more.
Centralize data validation and submission
Manage data validations and submissions through a single solution, eliminating fragmented tools and redundant processes.
Enhance data quality and governance
Leverage built-in dashboards, business rules, audit trails, and approval gates to ensure complete, validated, and compliant UDI data globally.
Reduce operational and IT cost
Eliminate multiple integrations and manual effort with a purpose-built, global UDI submission solution that lowers TCO.
Ensure compliance with quality & security standards
Meet regulatory requirements for system quality, security, and data integrity including 21 CFR Part 11, Annex 11 and GAMP 5 system validation standards.
Capability Highlights
Explore the core capabilities that enable efficient, scalable, and compliant device submissions across multiple global UDI databases.
| Category | Features |
|---|---|
| Data Import | Easily onboard device data from your ERP, PLM, PIM/MDM and other source applications |
| Data Maintenance | Out-of-the-box UDI data types, attributes, code lists and data validation rules for each UDI database Simplified data maintenance with configurable web forms and native bulk edit capability |
| Data Governance | Out-of-the-box data validation rules for each UDI database Audit trail and complete version history of data changes Easy-to-configure approval gates enabled with eSignature Complete approval history Granular role-based security Data quality dashboard to track data validation and submission status across UDI databases |
| Data Submission | Native M2M connectivity to GUDID, EUDAMED, AusUDID and others Secure and reliable communication with their respective messaging protocol and XML format Message log for full message exchange history with each UDI database Ability to export XML for upload to UDI databases |
| Compliance | 21 CFR Part 11 and Annex 11 GAMP 5 System Validation ISO 27001, SOC 2 and other relevant information security standards Independent USDM audit proving compliance and GxP readiness |
“Innovit UDI Multi Connector streamlines device data submission to multiple UDI databases globally.“
Data Flow Models for UDI Compliance
With Innovit UDI Multi-Connector, customers can leverage pre-packaged and custom data flow models to support their internal business processes for aggregating, maintaining, validating and submitting their device data. The pre-packaged data flow models come in 2-Stage and 3-Stage variations, while also providing a Passthrough option for organizations who do not have users maintaining data in Innovit’s application.
2-Stage Data Flow Model
This model has two distinct stages: maintenance and submission. The maintenance stage comes pre-packaged with all the data types, attributes, code lists and data validation rules that customers need to manage and validate their device data for a given UDI database. Once the data is validated and ready for submission, it is released to the submission stage where users can submit their clean and validated data to the UDI database.
Best For:
Organizations with no upstream systems or data aggregation needs, where users either create records directly in Innovit’s application or import device data in the required UDI format.
3-Stage Data Flow Model
This model has three distinct stages: aggregation, maintenance, and submission. The aggregation stage allows users to consolidate and cleanse raw device data from multiple source systems to create a complete device record. The data is then converted into the required UDI format in the maintenance stage and follows the standard data validation and submission process as the 2-stage model.
Best For:
Organizations with multiple source systems that need to aggregate, cleanse, and normalize device data before converting it into the relevant UDI format for validation and submission.
Passthrough Data Flow Model
This model supports a fully automated flow where device data is maintained upstream and only passes through Innovit’s solution for data validation and submission. Device data is automatically imported, mapped and validated against UDI database rules, and submitted without manual intervention. Data validation and submission reports are sent back to the source system, where any corrections are made and resubmitted.
Best For:
Organizations with upstream systems where users manage all device data and require a fully automated data validation and submission process.
User Configurable Workflow Model
This model leverages Innovit’s Collabri workflow engine to enable fully configurable, advanced workflow orchestration. Users can design custom data flows with multiple stages, dynamic routing, and role-based tasks using a visual interface. It supports complex approval processes, conditional logic, escalation policies and automated task management to handle sophisticated data management and governance requirements.
Best For:
Organizations with advanced governance, approval, or regulatory review processes requiring configurable workflow orchestration.
Hosting
Different hosting options are available for customers.
Multi-Tenanted
Public Cloud
Shared environment with shared server
Single-Tenanted
Hybrid Cloud
Dedicated environment with dedicated server
Single-Tenanted
Private Cloud
Dedicated environment with dedicated server