Introduction
The UDI Submission Challenge Regulatory Affairs Must Solve Today
Regulatory Affairs teams are accountable for ensuring UDI data is accurate, compliant, and defensible across global databases including GUDID, EUDAMED, AusUDID, and swissdamed. Yet some UDI solutions introduce added complexity and reduce visibility into how device data is managed and submitted. The challenge is not just meeting submission deadlines, but maintaining control over UDI data and processes as regulations evolve globally. The right solution should have native compliance capabilities, enforce data validation, provide best-practice workflows, and ensure UDI data is consistently submission-ready.
This eBook outlines the key dimensions Regulatory Affairs should evaluate in a UDI solution, and how Innovit enables controlled and scalable compliance while strengthening audit readiness and submission reliability worldwide.
Table of Contents
This eBook is structured to help you quickly navigate the key areas Regulatory Affairs should evaluate in a UDI submission solution. Each section focuses on a specific capability, outlining what to look for, how Innovit delivers and why it matters.
Use the table of contents to jump directly to the sections most relevant to your priorities or current challenges.
Executive Summary
System Integration & Data Aggregation
System Integration & Data Aggregation
Data Management and Approval Workflows
Ease of Use
Audit Trail & Traceability
Submission Control & Visibility
M2M Data Submission
Compliance Standards and System Validation
Implementation Speed & Cost Efficiency
Support and Ongoing Maintenance
Reliable Partner with Deep Healthcare Expertise
Conclusion
Executive Summary
UDI compliance introduces risk when device data, workflows, and submissions are not tightly controlled. Regulatory Affairs must ensure consistency, traceability, and accountability across the entire UDI submission lifecycle. Innovit addresses this by providing control directly into how UDI data is managed, validated, approved, and submitted globally.
Leverage Native UDI Data Models
Innovit incorporates global UDI data models, data validation rules, and submission formats into a single solution, ensuring compliance across UDI databases without manual, error-prone processes.
Integrate and Aggregate UDI Data
Device data can be sourced from multiple enterprise systems and consolidated into a single solution, ensuring consistency, completeness, and availability for timely submission.
Enforce Best-Practice Workflows
Innovit provides pre-packaged and configurable workflows with role-based access and approval gates, ensuring only validated and approved data progresses to submission.
Validate UDI Data Early and Continuously
Built-in data validation rules for GUDID, EUDAMED, AusUDID, swissdamed and more are applied during data maintenance, ensuring data issues are identified and resolved before submission.
Ensure Audit-Ready & Compliant System
Innovit natively supports 21 CFR Part 11 and EU Annex 11 requirements, while aligning with GAMP 5 system validation standards and meeting ISO 27001 and SOC 2 specifications for quality and data security.
Control and Automate UDI Submissions
Innovit provides a dedicated submission area with native M2M submission capabilities that give RA full visibility into submission status and responses coming from UDI databases.
Accelerate Time to Compliance
Innovit enables rapid implementation through pre-configured data models, workflows, and flexible deployment options, reducing complexity and allowing organizations to achieve UDI compliance efficiently.
Stay Compliant with a Trusted Partner
Backed by deep healthcare and regulatory expertise, Innovit delivers continuous updates, proactive guidance, and proven solutions to help Regulatory Affairs maintain compliance as global UDI requirements evolve.
Global UDI Compliance
Global UDI Compliance
Can You Stay Compliant Across Markets?
What RA Needs
Regulatory Affairs must ensure device data complies with multiple UDI databases, each with unique attributes, data validation rules and submission requirements.
Key Concerns:
- Expanding UDI regulations worldwide
- Manual tracking of regulatory updates
- Inconsistent global compliance
- Increased compliance risk
RA needs a system that:
- Aligns natively with global UDI specifications
- Updates continuously with evolving regulations
- Standardizes UDI submission processes
- Reduces manual interpretation
Global UDI compliance must be built into the system, not managed manually.
How Innovit Delivers
Innovit’s UDI solution provides out-of-the-box capabilities to manage and submit device data to multiple UDI registries worldwide including GUDID, EUDAMED, AusUDID, swissdamed, and more. This includes:
- Built-in data models for each UDI database
- Pre-packaged attributes, code lists, and data validation rules
- Native M2M connectivity to relevant UDI databases
- Standardized & best practice workflows for UDI submission
- Continuous and timely product updates for evolving regulations
By embedding regional UDI data models and M2M specifications, Innovit’s solution enables a single application with consistent UI/UX and standardized processes for global UDI registration.
1
Ongoing compliance
2
Dependable
support
3
Reliable
performance
Global UDI submission is built into a single system, ensuring consistency and best practice compliance processes across regions.
Why This Matters
Global UDI requirements evolve continuously across regions. Embedding regulatory requirements into the system simplifies compliance without constant manual tracking, reducing risk and enabling Regulatory Affairs to focus on oversight.
System Integration & Data Aggregation
System Integration & Data Aggregation
Can You Bring the Right UDI Data Together Reliably?
What RA Needs
UDI data may originate from multiple enterprise systems including ERP, PLM, PIM/MDM and RIM applications. Regulatory Affairs must ensure required device data is reliably sourced, aggregated and prepared for UDI submission.
Key Concerns:
- Fragmented UDI data across systems
- Inconsistent and missing attributes
- Manual data consolidation effort
- Costly system integrations
RA needs a system that:
- Integrates seamlessly with multiple data sources
- Automates data aggregation and transformation
- Ensures consistent and complete device data
- Provides a unified view for data aggregation
If UDI data is fragmented, submitting it reliably becomes a challenge.
How Innovit Delivers
Innovit’s UDI solution provides flexible integration capabilities to aggregate device data from multiple enterprise systems into a single solution. This includes:
- Integration with ERP, PIM, MDM, and other product data systems
- File-based and API-based data ingestion in different file formats
- Automated import scheduling for continuous data onboarding
- Data mapping and transformation into UDI data models
- Centralized aggregation stage for data consolidation and cleansing
UDI data is consolidated into a single system to enable data transformation and validation against UDI database specifications.
1
Faster data aggregation
2
Reuse of
existing data
3
Reduced
manual effort
Integration is designed to adapt to your organization’s existing data and IT landscape.
Why This Matters
UDI data can originate from multiple systems and in different formats. Reliable aggregation ensures all relevant data is available for submission to UDI databases.
Data Management and Approval Workflows
Data Management and Approval Workflows
Do You Have Control Over How UDI Data Is Created, Reviewed, and Approved?
What RA Needs
UDI data is often created and maintained by multiple teams. Regulatory Affairs must ensure it is controlled, reviewed, and approved consistently before submission.
Key Concerns:
- Unclear data ownership
- Inconsistent or undocumented approvals
- Uncontrolled UDI data changes
- Lack of accountability
RA needs a system that:
- Defines clear data ownership
- Enforces structured approval workflows
- Prevents unapproved UDI data from submission
- Tracks all approvals and changes
If the data ownership and approval process is not controlled, the UDI data cannot be trusted.
How Innovit Delivers
Innovit’s UDI solution provides best-practice workflows that govern how UDI data is maintained, reviewed, and approved prior to submission. This includes:
- Role-based access to UDI data maintenance & approval
- Defined stages for data aggregation, maintenance and submission
- Configurable checkpoints for data review and approval at each stage
- Visibility into pending tasks and workflow status
- eSignature support with full approval history
By providing these controls in the system, Innovit’s solution ensures UDI data is reviewed consistently, approvals are documented, and only validated and approved data is staged for submission.
1
Controlled
workflows
2
Approval
transparency
3
Audit
readiness
Control over workflow translates directly into control over UDI compliance.
Why This Matters
Unstructured workflows create inconsistencies and lack transparency. Controlled workflows ensure accountability and confidence that only approved UDI data is submitted.
Ease of Use
Ease of Use
Can Users Operate Without Friction or Dependency?
What RA Needs
UDI data is maintained by multiple teams. Systems must be intuitive to drive broad adoption and ensure consistent and reliable contribution across users.
Key Concerns:
- Complex user interfaces
- High training requirements
- Data entry errors
- Low or inconsistent system adoption
RA needs a system that:
- Provides intuitive interfaces
- Requires minimal training
- Optimizes web forms for each role
- Enables efficient data updates
Ease of use is not just about productivity. It is about ensuring that every contributor can accurately & consistently do their part in maintaining compliant UDI data.
How Innovit Delivers
Innovit is designed for immediate usability, minimizing training and enabling fast adoption across teams. This includes:
- Modern UI/UX optimized for UDI submission processes
- Configurable web forms for simplified data entry
- Native data validation and bulk edit capabilities
- On-screen tooltips and contextual explanations
- Embedded knowledge center for user support
With these capabilities, users can complete tasks quickly and reliably without reliance on extensive training.
1
Easier
Adoption
2
Increased
productivity
3
Fewer
errors
Ease of use enables every team to contribute accurately and efficiently towards UDI compliance.
Why This Matters
UDI data spans multiple teams. Ease of use ensures adoption across teams, enabling compliance as a shared and scalable process.
Data Integrity and Reliability
Data Integrity and Reliability
Can You Trust Your UDI Data?
What RA Needs
UDI data must be accurate and complete before submission. If invalid or missing data is allowed to progress, it increases the likelihood of submission failures, rework, and audit risk.
Key Concerns:
- Late discovery of data issues
- UDI Submission failures
- Last-minute manual corrections
- Compliance and audit risk
RA needs a system that:
- Validates UDI data early and consistently
- Prevents invalid data from submission
- Provides clear error identification
- Enables efficient corrections
UDI data should be correct long before submission, so RA is not relying on last-minute checks to catch errors.
How Innovit Delivers
Innovit enforces data quality early to prevent downstream issues and last-minute corrections. This includes:
- Built-in data validation rules aligned with UDI database requirements
- Prevention of invalid or incomplete data from submission
- Data validation results at an attribute, record and catalog level
- Easy navigation to erroneous data for bulk remediation
- A data quality dashboard with validation report across UDI databases
UDI data is validated early and consistently, ensuring valid device records before submission.
1
Early validation
insights
2
Less manual
rework
3
Confident
submissions
UDI data is validated early, issues are quickly resolved, and quality is continuously elevated.
Why This Matters
Proactive data validation ensures that only complete and validated device data moves forward to the submission stage, minimizing compliance risk.
Audit Trail & Traceability
Audit Trail & Traceability
Can You Prove Who Changed What and When?
What RA Needs
Regulatory compliance requires full traceability of UDI data in line with 21 CFR Part 11 and Annex 11 requirements. RA must demonstrate how data was created, modified, and approved.
Key Concerns:
- Lack of data transparency
- Unclear accountability
- Non-compliance with industry regulations
- Audit risk
RA needs a system that:
- Tracks all UDI data changes
- Shows who changed what and when
- Provides searchable version history
- Supports audit requirements
If RA cannot trace how UDI data evolved, they cannot fully defend it.
How Innovit Delivers
Innovit provides complete visibility into all data changes to ensure traceability and accountability. This includes:
- Attribute-level versioning for all product data
- Visibility into who changed what and when
- Searchable and filterable change history
- Exportable audit logs for reporting and review
- Compliance with 21 CFR Part 11 and Annex 11 requirements
Every data change is captured and easily traceable.
1
Full
Visibility
2
Clear
accountability
3
Audit
readiness
Every change is recorded, every action is traceable, and every device record is defensible.
Why This Matters
A complete audit trail ensures that every change to UDI data is transparent and defensible during audits.
Submission Control & Visibility
Submission Control & Visibility
Do You Have Full Oversight Before UDI Data Is Submitted?
What RA Needs
Data validation ensures device data meets UDI database requirements, but RA must maintain full visibility and control over what is submitted and when.
Key Concerns:
- Lack of submission control
- Limited visibility into submitted data
- Unapproved data submission
- Weak audit defensibility
RA needs a system that:
- Provides a dedicated staging area for submission
- Ensures only valid UDI data is staged for submission
- Enables control over submission processes
- Tracks submission activity
Data validation prevents bad data, but control ensures responsible UDI submissions.
How Innovit Delivers
Innovit’s UDI solution provides a structured and controlled submission process that ensures Regulatory Affairs maintains full oversight from data validation through final submission. This includes:
- A dedicated staging environment for UDI submission
- Controlled selection of one or more records
- Final re-validation of selected records against UDI database rules
- Real-time submission status tracking
- Centralized access to UDI database responses
With these capabilities, Innovit’s UDI solution ensures that submission is controlled, visible, and traceable.
1
Controlled
submissions
2
Full visibility
3
Reduced
risk
Submission should never be a blind step. It should be deliberate, traceable, and governed.
Why This Matters
RA must control what is submitted and when. A controlled UDI submission process ensures that every device record is reviewed, approved, and traceable.
M2M Data Submission
M2M Data Submission
Can You Submit UDI Data Reliably at Scale?
What RA Needs
As UDI requirements expand across regions and product portfolios grow, manual or semi-manual submission processes become increasingly difficult to sustain.
Key Concerns:
- Non-scalable submission processes
- Last minute submission errors
- Lack of scalability
- Compliance risk
RA needs a system that:
- Automates UDI submissions where applicable
- Supports native M2M submissions to UDI registries
- Reduces manual intervention
- Ensures reliable outcomes
As device volume increases, manual UDI submissions become a bottleneck and a compliance risk.
How Innovit Delivers
Innovit’s UDI solution enables reliable and scalable submission through purpose-built machine-to-machine (M2M) connectivity with global regulatory databases. This includes:
- Out-of-the-box M2M connectivity to global UDI databases
- Generation of required XML format for each database
- Real-time tracking of submission status and responses
- Complete message logs for all outbound and inbound exchanges
- Native dashboard to track submission status across UDI databases
With these capabilities, Innovit’s UDI solution ensures that submissions are not only automated, but also fully transparent and traceable.
1
Scalable
execution
2
Reduced
errors
3
Faster
submissions
M2M submission is not just about automation. It is about executing at scale with full visibility, traceability, and control.
Why This Matters
Manual processes introduce compliance risk and delays. M2M connectivity enables consistent and automated submissions while maintaining full visibility and control.
Compliance Standards & System Validation
Compliance Standards & System Validation
Will Your System Meet Regulatory Expectations?
What RA Needs
RA is not only responsible for the accuracy of UDI data, but also for ensuring that the systems used to manage and submit that data meet regulatory expectations for quality, data integrity and security.
Key Concerns:
- Non-compliant systems
- Data integrity and security risks
- System validation complexity
- Audit failures
RA needs a system that:
- Adheres to relevant regulatory compliance standards
- Ensures data integrity and security
- Supports GAMP 5 system validation efforts
- Provides relevant product and process documentation
It is not enough for UDI data to be compliant. The system managing that data must also be compliant.
How Innovit Delivers
Innovit’s UDI solution is built to meet regulatory requirements in life sciences for system compliance, validation, and data integrity. This includes:
- Native support for 21 CFR Part 11 and EU Annex 11
- Alignment with GAMP 5 system validation framework
- Compliance with ISO 27001 and SOC 2 standards
- Role-based access control and secure data handling
- Independent USDM audit proving GxP readiness
Innovit’s UDI solution is designed to meet stringent regulatory standards in medical device and life sciences environments.
1
Regulatory
compliance
2
Reduced
validation effort
3
Reliable system
Compliance is not an afterthought. It is built into the system, validated, and continuously proven.
Why This Matters
Regulators assess both the data and the systems used to manage it. A compliant system ensures audit readiness and reduces regulatory risk.
Implementation Speed & Cost Efficiency
Implementation Speed & Cost Efficiency
How Quickly Can You Achieve UDI Compliance?
What RA Needs
Implementation delays can impact compliance timelines. RA needs a solution that can be deployed quickly without unnecessary complexity and cost.
Key Concerns:
- Long implementation timelines
- High implementation costs
- Heavy customization requirements
- Unscalable system configurations
RA needs a system that:
- Accelerates time to compliance
- Minimizes customizations
- Reduces implementation cost
- Provides scalable configurations
Delayed implementation is not just a project risk. It is a compliance risk.
How Innovit Delivers
Innovit provides flexible and efficient implementation options, allowing customers to move quickly while aligning with their internal capabilities and timelines. This includes:
- Pre-configured UDI data models and workflows
- Self-service implementation capabilities
- Expert-led implementation support
- Best-practice implementation frameworks
- Flexible configurations and no customizations
Implementation of Innovit’s UDI solution is streamlined, enabling faster time to compliance without unnecessary effort and cost.
1
Faster
deployment
2
Lower cost
3
Reliable
compliance
Implementation is designed to deliver speed, control, and cost efficiency while adapting to your organization’s needs.
Why This Matters
Complex implementations delay UDI compliance and increase cost. Efficient implementation enables faster time to compliance and reduces operational risk.
Support and Ongoing Maintenance
Support and Ongoing Maintenance
Can You Stay Compliant Without Interruption?
What RA Needs
UDI compliance must be maintained continuously as regulations evolve. RA needs a UDI submission system that remains current, stable, and supported.
Key Concerns:
- Evolving regulatory requirements
- Outdated system capabilities
- Slow issue resolution
- Lack of ongoing support and guidance
RA needs a system that:
- Keeps pace with UDI regulatory changes
- Provides continuous and timely updates
- Delivers responsive and reliable support
- Offers proactive guidance
UDI compliance must be continuously maintained, not periodically addressed.
How Innovit Delivers
Innovit removes the burden of ongoing UDI compliance by continuously managing product updates, support, and performance in the background. This includes:
- Timely product updates aligned with UDI regulatory changes
- Ongoing maintenance ensuring system performance, stability, and security
- Responsive support trained on the most recent UDI developments
- Embedded knowledge center with relevant and timely guidance
- Access to experts with deep system and regulatory knowledge
Innovit’s system stays current, supported, and aligned with evolving UDI regulations to ensure ongoing compliance.
1
Ongoing
compliance
2
Dependable
support
3
Reliable
performance
Innovit’s solution is continuously updated and maintained. Users are supported with timely guidance and responsive expertise.
Why This Matters
UDI requirements evolve continuously. Ongoing support and timely product updates ensure reliable compliance as requirements change.
Reliable Partner with Deep Healthcare Expertise
Reliable Partner with Deep Healthcare Expertise
Do You Have a Partner That Understands UDI Compliance?
What RA Needs
Selecting a UDI solution is a long-term decision. RA needs a partner with deep expertise in healthcare regulations and product data management.
Key Concerns:
- Limited UDI and related regulatory expertise
- Poor track record of successful implementations
- Lack of ongoing investment in UDI solutions
- Reactive approach to regulatory changes
RA needs a system that:
- Is backed by deep healthcare expertise
- Has proven success in customer implementations
- Provides roadmap and ongoing support for UDI solutions
- Anticipates regulatory changes
A strong technology partner reduces risk over time and supports long-term scalability.
How Innovit Delivers
Innovit combines deep healthcare expertise with proven solutions to support long-term success. This includes:
- 25+ years of healthcare and life sciences experience
- Strategic partnerships with MedTech Europe, GS1 and USDM
- Proven enterprise-grade solution used by global organizations
- Active participation in UDI regulatory initiatives and testing
- First to successfully test EUDAMED M2M device submissions
Innovit provides expertise and partnership that supports long-term operational success.
1
Proven expertise
2
Trusted partner
3
Long-term
support
Deep healthcare expertise is built into Innovit’s UDI solution. Customers are supported with proven experience and ongoing partnership.
Why This Matters
Deep expertise from a solution partner reduces the burden of navigating complex UDI requirements globally, while reducing operational and regulatory risk.
Conclusion
Final Takeaways for Regulatory Affairs
Regulatory Affairs is accountable not just for UDI submission, but for how the data is managed, validated, and controlled over time. Innovit enables this by embedding global UDI compliance capabilities into the solution, enforcing best-practice workflows, and ensuring data remains accurate, traceable, and ready for submission across global UDI databases.
Regulatory Affairs must be able to:
- Leverage native UDI data models
- Validate data early
- Control data and submission workflows
- Establish transparency and accountability
- Ensure audit readiness
Innovit enables Regulatory Affairs to govern UDI data, ensure audit readiness, and scale reliable submissions across global markets.
