OVERVIEW
The FDA’s Global Unique Device Identification Database (GUDID) serves as the central repository for device identification information required under the U.S. Unique Device Identification (UDI) Rule. Medical device labelers marketing products in the United States are responsible for submitting and maintaining accurate device information in accordance with FDA regulations and technical specifications.
Innovit GUDID Connector streamlines the collection, validation, and electronic submission of UDI data to the GUDID. Designed 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 GUDID CONNECTOR
Innovit GUDID Connector is a purpose-built solution that enables medical device labelers to efficiently prepare, validate, and submit UDI data to the FDA. The application includes a pre-configured GUDID data model, built-in business rules, required attributes, and controlled code lists, helping organizations improve data quality while reducing the effort required to meet FDA submission requirements.
Native integration with GUDID supports secure machine-to-machine submissions using the FDA’s NextGen API and AS2 communication protocols with HL7 SPL XML messaging. The solution also provides configurable approval workflows with electronic signatures, comprehensive audit trails, and detailed submission logs, giving organizations complete visibility into data changes, submission activity, acknowledgements, and FDA responses.
Innovit continuously maintains the solution in line with FDA GUDID technical specifications and regulatory updates, helping customers simplify ongoing compliance and efficiently manage device information throughout its lifecycle.
BENEFITS
Accelerate GUDID device submissions
Meet evolving FDA UDI submission requirements through a purpose-built solution designed specifically for the GUDID.
Ensure data quality before submission
Validate device information using native GUDID 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 the GUDID 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 GUDID.
| Category | Features |
|---|---|
| Data Import | Easily onboard device data from your ERP, PLM, PIM/MDM and other source applications |
| Data Maintenance | Out-of-the-box GUDID 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 GUDID 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 GUDID |
| Data Submission | Native M2M connectivity to GUDID FDA NextGen API with required HL7 SPL XML support Full visibility to GUDID responses and submission status Message log for full message exchange history with the GUDID |
| Compliance | FDA 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 GUDID Connector simplifies FDA UDI compliance through built-in data validation, secure HL7 SPL submissions, and end-to-end visibility from data preparation to regulatory acknowledgement.”
Data Flow Models for GUDID Submission
With Innovit GUDID 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 GUDID 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 the GUDID.
Best For:
Organizations maintaining device information directly within Innovit or importing data already aligned with the GUDID 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 GUDID 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 GUDID 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 GUDID 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 shared server
Single-Tenanted
Private Cloud
Dedicated environment with dedicated server
