OVERVIEW
The Australian Therapeutic Goods Administration (TGA) has established the Australian Unique Device Identification Database (AusUDID) to support the identification and traceability of medical devices supplied in Australia. Sponsors are responsible for submitting and maintaining accurate UDI and device information in AusUDID in accordance with the TGA’s regulatory and technical requirements.
Innovit AusUDID Connector simplifies the aggregation, management, validation, and machine-to-machine (M2M) submission of device data to AusUDID. Built specifically for regulated healthcare environments, it supports GAMP 5 system validation principles and addresses the requirements of 21 CFR Part 11 and EU Annex 11.
INNOVIT AUSUDID CONNECTOR
Innovit AusUDID Connector provides a purpose-built solution for medical device sponsors to manage, validate, and submit compliant UDI data to AusUDID. The solution includes a pre-configured AusUDID data model with the required data types, attributes, code lists, and validation rules, helping organizations efficiently prepare high-quality device data while maintaining alignment with TGA requirements.
The solution provides native machine-to-machine connectivity to AusUDID, enabling secure electronic submission of UDI records using the communication protocols and HL7 SPL XML format specified by the TGA. Comprehensive audit trails, configurable approval workflows enabled with electronic signature, and complete message exchange history provide full visibility into data changes, approvals, submissions, and AusUDID responses.
Innovit continuously maintains the solution to reflect evolving AusUDID technical specifications and regulatory requirements, enabling organizations to efficiently manage ongoing compliance as Australia’s UDI framework continues to evolve.
BENEFITS
Accelerate AusUDID device submissions
Meet evolving TGA UDI submission requirements through a purpose-built solution designed specifically for AusUDID.
Ensure data quality before submission
Validate device information using native AusUDID business rules to identify issues before submission and reduce errors.
Streamline data governance and approvals
Strengthen data integrity with configurable approval workflows, audit trails, electronic signatures, and complete submission history.
Reduce operational and IT cost
Eliminate custom integrations and manual effort with a purpose-built, M2M submission to AusUDID 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, reliable, and compliant device submissions to AusUDID.
| Category | Features |
|---|---|
| Data Import | Easily onboard device data from your ERP, PLM, PIM/MDM and other source applications |
| Data Maintenance | Out-of-the-box AusUDID data model with relevant data types, attributes, code lists and data validation rules Simplified data maintenance with configurable web forms and native bulk edit capability |
| Data Governance | Native AusUDID data validation rules 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 for AusUDID |
| Data Submission | Native M2M connectivity to AusUDID Out-of-the-box support for the required HL7 SPL XML Full visibility to AusUDID responses and submission status Message log for full message exchange history with AusUDID |
| Compliance | TGA UDI requirements 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 AusUDID Connector helps sponsors efficiently manage, validate, and submit compliant UDI data to AusUDID through a single, purpose-built platform.”
Data Flow Models for AusUDID Submission
With Innovit AUSUDID 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 the AusUDID attributes, code lists and data validation rules that customers need to manage and validate their device data. Once the data is validated and approved, it is released to the submission stage where users can submit their clean and validated data to AusUDID .
Best For:
Organizations maintaining device information directly within Innovit or importing data already aligned with the AusUDID 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 AusUDID 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 AusUDID format.
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 AusUDID 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
