Overview
The UDI Compliance Consulting-Led Implementation approach is designed for organizations that want to work directly with Innovit’s implementation consultants to plan, configure, integrate, and deploy their UDI submission solution using a structured implementation methodology aligned with best-practices and global UDI regulatory requirements.
This approach is intended for Advanced and Premium package customers with more advanced regulatory, business, or integration requirements. Innovit’s consultants work alongside project teams to configure the solution, integrate enterprise systems, establish data governance processes, and prepare the organization for reliable device data submissions to the relevant UDI database(s).
Successful UDI compliance requires more than deploying a UDI submission platform. They depend on trusted product data, well-defined governance, best practice business processes, and coordinated implementation across Regulatory Affairs, Quality, IT, and other stakeholders. By following Innovit’s proven UDI implementation methodology, organizations can reduce implementation risk, improve data quality, ensure timely submissions, and establish sustainable processes for ongoing UDI compliance.
Implementation Phases
The following phases outline a recommended implementation sequence for organizations adopting Innovit’s UDI Connectors using the Consulting-Led Implementation approach. Depending on the UDI database, implementation scope, and organizational processes, additional activities may be required.
Project Initiation
Objective
Establish project governance, align stakeholders, confirm scope, and prepare the organization for implementation activities.
Key Activities
Project Governance
- Execute project agreements
- Identify project stakeholders and roles
- Establish communication and escalation procedures
- Define project governance structure
Project Planning
- Confirm project scope, objectives, target markets, and applicable UDI registries (e.g., GUDID, EUDAMED, AUSUDID, Swissdamed)
- Define project success criteria
- Develop project schedule and resource plan
- Identify project risks and dependencies
Project Kickoff
- Conduct project kickoff meeting
- Review implementation approach and timeline
- Align stakeholders on responsibilities and expectations
Deliverables
Project charter, governance & communication plan, project schedule, risk & dependency register
Requirements Discovery
Objective
Understand UDI compliance requirements, assess current business processes and data sources, and define the future-state operating model to support compliant UDI submissions.
Key Activities
Regulatory & Business Requirements Assessment
- Review applicable UDI regulatory requirements and submission obligations
- Conduct stakeholder workshops to document current-state processes
- Identify key pain-points and challenges to be prioritized and addressed
- Define future-state business processes for data management, approval, and submission
Data Discovery & Governance
- Identify authoritative source systems for UDI attributes
- Assess data ownership, stewardship, approval workflows, and accountability
- Evaluate data quality, completeness, and readiness for submission
- Identify gaps requiring remediation
Integration & Architecture Assessment
- Identify source systems and integration requirements
- Identify target regulatory repositories and submission channels
- Identify high-level data flows and system interactions
- Identify data validation, exception handling, and monitoring needs
Requirements & Solution Blueprint
- Document business, functional and any technical requirements identified
- Establish traceability between business requirements and solution design
- Develop high-level blueprint for future-state solution
Deliverables
Functional Requirements Specification (FRS), Requirements Traceability Matrix (RTM), high-level solution blueprint
Solution Design
Objective
Define the technical architecture, data model, integrations, and operational controls required to support UDI data management and regulatory submissions.
Key Activities
Solution Architecture
- Define solution architecture and deployment approach
- Define source-to-target data flows
- Define integration framework and required interfaces
Data Management Processes
- Define data model for source system data aggregation and harmonization
- Define data mapping and transformation rules between source systems and UDI attributes
- Define UDI data management and approval workflows
Data Governance Processes
- Establish data security and access control framework
- Define audit trail and electronic signature controls
- Define submission monitoring, exception management, and operational support procedures
Deliverables
Technical Design Specification (TDS), Solution Architecture Diagram, Integration Design Document, Updated Requirements Traceability Matrix (RTM), Test Strategy and Test Scripts
Environment and Connectivity Setup
Objective
Prepare environments and establish connectivity between source systems, Innovit’s solution, and relevant UDI databases.
Key Activities
- Provision Development, Test, and Production environments
- Configure infrastructure and security controls
- Configure certificates and authentication mechaisms
- Establish connectivity with regulatory repositories
- Validate end-to-end connectivity
Deliverables
Environment readiness confirmation, M2M connectivity confirmation for UDI databases
Configuration & Build
Objective
Configure the solution to support UDI data management, validation, and submission processes.
Key Activities
Solution Configuration
- Configure connectors and integrations
- Configure users and roles
- Configure workflow routing and approval gates
- Configure data maintenance and submission processes
- Configure monitoring and exception handling
Data Preparation
- Prepare migration and validation datasets
- Configure transformation and mapping logic
- Load test data
Unit Testing
- Validate system configuration
- Validate business rules
- Validate integrations and data flows
Deliverables
Configured solution, data migration plan, unit test results, configuration documentation
User Acceptance Testing
Objective
Validate that the solution meets business, data pool, trading partner, and operational requirements prior to production deployment.
Key Activities
UAT Preparation
- Deploy solution to test (UAT) environment
- Prepare test data and test scenarios
- Conduct user training
UAT Execution
- Execute business and regulatory test scenarios
- Validate submission processes
- Validate exception handling and reconciliation procedures
- Support issue resolution and retesting
Approval
- Review test results
- Obtain stakeholder approval
- Confirm production readiness
Deliverables
UAT test results, defect resolution log, UAT sign-off
Production Deployment
Objective
Deploy the solution into production and establish operational UDI submission processes.
Key Activities
Production Preparation
- Configure production environment
- Execute data migration
- Perform data validation and reconciliation
- Execute cutover activities
Go-Live
- Enable production integrations
- Execute initial submissions
- Validate successful submission processing and acknowledgements
Stabilization
- Monitor production activity
- Address deployment issues (if any)
Deliverables
Production deployment report, data migration validation report, go-live approval
Hypercare and Transition
Objective
Ensure operational stability and transition ownership to business and support teams.
Key Activities
Hypercare Support
- Monitor system performance
- Resolve post-go-live issues
- Support business users and regulatory teams
Knowledge Transfer
- Conduct operational handover sessions
- Transfer documentation, relevant Knowledge Base resources, and support procedures
- Transition operational procedures to business users & support teams
Project Closure
- Review project objectives and outcomes
- Document lessons learned
- Complete project closure activities
Deliverables
Operational support procedures, knowledge transfer materials, project closure report & transition to support sign-off
