Introduction
The UDI Compliance Challenge Quality Assurance Must Solve
Quality Assurance teams are responsible for ensuring that both UDI data and the systems managing that data meet regulatory requirements for quality, data integrity, and data security. Yet some UDI solutions introduce gaps in traceability, system compliance, and audit readiness. The challenge is not just submitting accurate UDI data but ensuring that the systems and processes managing UDI data also remain compliant with regulations, including 21 CFR Part 11, Annex 11 and GAMP 5 system validation standards.
This eBook outlines the key dimensions Quality Assurance should evaluate in a UDI solution, and how Innovit enables compliant, validated, and audit-ready UDI solutions and processes.
Table of Contents
This eBook is structured to help you quickly navigate the key areas Quality Assurance should evaluate in a UDI submission solution. Each section focuses on a specific requirement, 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
As UDI requirements continue to expand globally, Quality Assurance teams play a critical role in ensuring that systems used to manage UDI data support system validation, data integrity, data security, and other compliance requirements. Beyond functionality, QA must have confidence that UDI solutions can withstand regulatory scrutiny, support GxP standards, and operate within a controlled and validated environment.
Innovit’s UDI solution is designed specifically for regulated healthcare environments, combining compliant system controls, validation-ready capabilities, proven security frameworks, and deep healthcare expertise. By enabling these capabilities in a purpose-built UDI platform, Innovit helps organizations reduce compliance risk, simplify system validation activities, and maintain confidence in their UDI processes as regulations evolve.
Ensure Compliance with 21 CFR Part 11 and EU Annex 11
Innovit provides role-based security, governed workflows, electronic signatures, and comprehensive audit trails to support 21 CFR Part 11 and EU Annex 11 requirements with full traceability of UDI data changes.
Simplify GAMP 5 System Validation
Purpose-built UDI functionality, controlled configurations, and comprehensive documentation help organizations reduce system validation effort while maintaining a risk-based approach aligned with GAMP 5 principles.
Leverage Enterprise-Grade Security Controls
Hosted on AWS and managed by Tech Data (Krish Software Services), Innovit leverages infrastructure and operational practices aligned with ISO 27001 and SOC 2 standards to provide a secure and controlled environment for regulated UDI data.
Benefit from Independent Assessment
An independent assessment by USDM provides objective evidence that Innovit’s solutions, quality systems and controls meet the GxP requirements of the Life Science industry.
Choose a Customer-Proven Solution
Innovit’s UDI submission solution supports global requirements in a single platform, allowing processes to scale across products and markets without increasing operational complexity.
Stay Compliant with a Trusted Partner
Backed by over 25 years of healthcare and life sciences experience, Innovit combines technology, regulatory expertise, and industry partnerships to help organizations maintain confidence in their UDI submission solutions.
21 CFR Part 11 and Annex 11
21 CFR Part 11 and Annex 11
Does Your System Meet Audit Trail and ERES Requirements?
What QA Needs
Quality Assurance is responsible for ensuring that regulated processes are supported by systems that maintain data integrity, traceability, and accountability. When UDI data is managed electronically, organizations must be able to demonstrate that records are secure, changes are traceable, approvals are controlled, and electronic signatures are compliant with regulatory expectations.
QA teams need confidence that UDI-related data management activities can withstand internal audits, regulatory inspections, and system validation reviews without relying on manual controls or procedural workarounds.
Key Concerns:
- Inability to demonstrate UDI data integrity
- Limited traceability of changes and approvals
- Non-compliant electronic records and signatures
- Increased audit and inspection risk
QA needs a system that:
- Ensures data security and segregation of roles
- Provides traceability for all data management activities
- Enforces compliant electronic signatures and approvals
- Maintains secure and trustworthy electronic records
Data integrity, traceability, and accountability should be built into the system for reliable compliance.
How Innovit Delivers
Innovit’s UDI solution incorporates the controls required to ensure reliable data security, full traceability and auditability required to comply with 21 CFR Part 11 and EU Annex 11 requirements. This includes:
- Role-based access controls and segregation of duties
- Configurable approval gates enabled with eSignature
- Attribute-level versioning for full audit trail of UDI data
- Ability to search and filter version history
- Exportable audit logs for reporting and review
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Improved audit readiness
2
Stronger data integrity controls
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Reduced compliance risk
Every change is recorded, every action is traceable, and every device record is defensible.
Why This Matters
Demonstrating control and transparency over changes to UDI records, approvals, and submissions help reduce compliance risk and strengthen data integrity.
GAMP 5 System Validation
GAMP 5 System Validation
Can Your UDI Solution Be Validated Efficiently and Reliably?
What QA Needs
Quality Assurance is responsible for ensuring that regulatory systems are validated and remain compliant with GxP standards throughout their lifecycle. Validation activities must provide documented evidence that a system performs as intended while maintaining data integrity, security, and regulatory compliance.
Systems that require extensive customization, complex configurations, or significant manual controls often increase system validation effort, create ongoing maintenance challenges, and raise the risk of validation gaps over time.
QA teams need a solution that enables a risk-based validation approach while minimizing the effort required to achieve and maintain a validated state.
Key Concerns:
- Excessive validation effort and documentation
- High levels of customization and configuration
- Maintaining a validated state after system changes
- Increased audit and inspection risk
QA needs a system that:
- Supports a risk-based validation approach
- Minimizes validation and revalidation effort
- Provides validation documentation and traceability
- Simplifies maintenance of a validated state
A well-designed UDI submission solution reduces system validation effort without compromising compliance.
How Innovit Delivers
Innovit’s UDI solution is designed to support efficient, risk-based GAMP 5 system validation while reducing the effort required to achieve and maintain compliance. This includes:
- Alignment with GAMP 5 risk-based validation principles
- Pre-configured UDI capabilities that reduce validation scope
- Controlled configuration and change management processes
- Relevant documentation to support qualification activities
By eliminating customizations and leveraging purpose-built functionality and configuration capabilities, Innovit helps organizations streamline system validation activities and simplify ongoing compliance.
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Reduced system validation effort
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Faster deployment & qualification
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Reliable compliance
System validation activities are simplified through standardized functionality, controlled configurations, and comprehensive documentation that supports a risk-based validation approach.
Why This Matters
UDI solutions that align with GAMP 5 principles help QA teams reduce system validation effort, maintain compliance more efficiently, and sustain a validated state throughout the system’s lifecycle.
ISO 27001 and SOC 2 Standards
ISO 27001 and SOC 2 Standards
Is Your System Secure and Compliant with Recognized Industry Standards?
What QA Needs
Quality Assurance is responsible for ensuring that systems supporting regulated processes operate within a controlled and secure environment. Beyond functionality and compliance, organizations must be able to demonstrate that appropriate controls exist to protect data, manage access, mitigate security risk, and support reliable system operation.
As organizations increasingly rely on cloud-based applications and third-party vendors, QA teams need confidence that their UDI solution is supported by a security and control framework aligned with recognized industry standards including ISO 27001 and SOC 2.
Key Concerns:
- Inadequate security and control frameworks
- Unauthorized access to regulated data
- Third-party vendor and supplier risk
- Increased audit and inspection exposure
QA needs a system that:
- Aligns with recognized security and compliance standards
- Protects regulated UDI data through controlled access
- Demonstrates effective operational and security controls
- Supports supplier qualification and audit activities
Recognized security standards provide confidence in system controls and operational integrity.
How Innovit Delivers
Innovit’s UDI solution is hosted on Amazon Web Services (AWS) and managed by Tech Data (Krish Software Services), leveraging enterprise-grade infrastructure, security controls, and operational practices aligned with recognized industry standards. This includes:
- AWS infrastructure supported by ISO 27001-certified information security management practices
- AWS and Tech Data operational controls aligned with SOC 2 requirements
- Data encryption in transit and at rest
- Role-based access controls and user permissions
- Continuous monitoring, backup, and disaster recovery capabilities
By leveraging established cloud infrastructure and managed services, Innovit provides a secure and controlled environment for managing UDI data and compliance processes.
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Improved security assurance
2
Reduced supplier risk
3
Greater compliance confidence
UDI data is managed within a secure and controlled environment supported by enterprise-grade infrastructure and recognized security standards.
Why This Matters
Leveraging established security and operational frameworks helps organizations reduce risk, simplify supplier qualification activities, and demonstrate that regulated UDI data is protected throughout its lifecycle.
Independent Audit
Independent Audit
Has the Solution Been Independently Assessed by a Trusted Third Party?
What QA Needs
Quality Assurance is responsible for evaluating whether software solutions are suitable for use in regulated environments. While vendors may provide documentation describing their compliance, controls, and validation practices, QA teams often require independent evidence to support supplier qualification, system validation activities, and audit readiness.
Independent assessments provide an objective evaluation of system controls, validation practices, and compliance readiness, helping organizations reduce risk and increase confidence in the systems they deploy.
Key Concerns:
- Reliance on vendor self-assessments
- Limited independent evidence of compliance readiness
- Increased supplier qualification effort
- Uncertainty during audits and inspections
QA needs a system that:
- Has been independently assessed by qualified experts
- Provides objective evidence of compliance readiness
- Supports supplier qualification activities
- Reduces audit and validation uncertainty
Independent assessments provide confidence that compliance claims can withstand scrutiny.
How Innovit Delivers
Innovit’s UDI solution has undergone an independent assessment by USDM to evaluate its suitability for use in regulated environments. This includes:
- Independent review of system quality and controls
- Assessment of validation practices and documentation
- Evaluation of GxP readiness
- Verification of compliance-related controls
- Confirmation of suitability for regulated use in Life Sciences
The independent assessment provides objective evidence that can support supplier qualification, validation, and audit readiness activities.
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Reduced supplier qualification effort
2
Increased compliance confidence
3
Lower implementation risk
Independent assessment provides objective evidence that the solution is suitable for regulated environments and supports GxP compliance expectations.
Why This Matters
Third-party assessments help QA teams reduce supplier risk, strengthen system validation and qualification activities, and increase confidence during audits and inspections.
Customer Proofpoint
Customer Proofpoint
Is the Solution Customer Proven in Regulated Environments?
What QA Needs
Quality Assurance is responsible for minimizing compliance and implementation risk when introducing new systems. While vendors may describe how a solution is designed to support compliance, QA teams also need evidence that the solution has been successfully deployed, validated, and operated within regulated environments.
Organizations gain greater confidence when a solution has demonstrated its ability to support compliance requirements, withstand audits, and scale across complex healthcare and life sciences organizations.
Key Concerns:
- Limited evidence of real-world compliance success
- Implementation and adoption risk
- Lack of experience in regulated environments
- Uncertainty regarding long-term scalability
QA needs a system that:
- Has a proven track record in regulated industries
- Demonstrates successful compliance outcomes
- Supports enterprise-scale deployments
- Reduces implementation and supplier risk
Regulated organizations should not have to prove a solution’s compliance-readiness for the first time.
How Innovit Delivers
Innovit’s UDI solution is trusted by medical device manufacturers and healthcare organizations operating in highly regulated environments worldwide. This includes:
- Successful deployments across global medical device organizations
- Support for regulated UDI compliance programs across multiple markets
- Proven operation within validated and GxP-regulated environments
- Enterprise-scale support for complex product portfolios
- A demonstrated track record of successful customer outcomes
These deployments provide evidence that the solution can support compliance, scalability, and operational requirements in real-world regulatory environments.
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Reduced implementation risk
2
Greater compliance confidence
3
Proven operational reliability
Organizations benefit from Innovit’s UDI solution that has demonstrated its ability to support compliance and scale successfully within regulated healthcare environments.
Why This Matters
Real-world adoption provides evidence that a UDI solution can support regulatory requirements, withstand operational demands, and deliver consistent outcomes in regulated environments.
Reliable Partner with Deep Healthcare Expertise
Reliable Partner with Deep Healthcare Expertise
Do You Have a Partner That Understands The Importance of Quality Assurance in Healthcare?
What QA Needs
Quality Assurance teams operate in highly regulated environments where compliance requirements, system validation expectations, and regulatory frameworks continue to evolve. Beyond technology, organizations need a partner that understands the unique quality, compliance, and regulatory challenges associated with managing healthcare product data and supporting global regulatory requirements.
The right partner should provide not only a UDI submission solution, but also the expertise needed to help organizations navigate changing requirements, support system validation activities, and maintain long-term compliance confidence.
Key Concerns:
- Limited healthcare and regulatory expertise
- Evolving global compliance requirements
- Dependence on internal subject matter experts
- Long-term compliance and support risk
QA needs a system that:
- Understands regulated healthcare environments
- Brings expertise in quality and compliance frameworks
- Provides guidance as regulatory requirements evolve
- Supports long-term compliance and validation initiatives
The right partner brings regulatory expertise, compliance insight, and long-term support—not just technology.
How Innovit Delivers
Innovit combines deep healthcare domain knowledge with extensive expertise in UDI compliance, product data management, system validation, and regulatory frameworks. This includes:
- 25+ years of healthcare and life sciences experience
- Proven expertise in UDI, GDSN, PIM, and MDM
- Strategic partnerships with GS1, MedTech Europe, and USDM
- Active participation in global UDI initiatives and M2M testing programs
- A proven track record supporting regulated healthcare organizations globally
This combination of technology, regulatory knowledge, and industry experience helps organizations navigate evolving compliance requirements with confidence.
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Trusted expertise
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Reduced compliance risk
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Long-term partnership
Organizations gain access to specialized healthcare and compliance expertise that supports successful system validation, regulatory readiness, and long-term compliance initiatives.
Why This Matters
Healthcare regulations, system validation expectations, and UDI requirements continue to evolve. A knowledgeable partner helps organizations adapt to change, reduce compliance risk, and maintain confidence in regulated environments.
Conclusion
Final Takeaways for Quality Assurance Professionals
UDI compliance requires more than implementing a UDI submission solution. Innovit supports Quality Assurance teams with built-in controls for 21 CFR Part 11 and EU Annex 11, GAMP 5-aligned system validation, enterprise-grade security, and independently assessed quality processes, helping organizations reduce compliance risk and maintain confidence in regulated healthcare environments
Quality Assurance Teams must be able to:
- Support data integrity and traceability in line with 21 CFR Part 11 and EU Annex 11 requirements
- Simplify GAMP 5 system validation and maintenance of a validated state
- Leverage secure infrastructure aligned with recognized industry standards
- Reduce supplier qualification and compliance risk through independent assessment
- Deploy a solution proven in regulated healthcare environments
- Benefit from deep healthcare, quality, and regulatory expertise
Innovit helps organizations achieve global UDI compliance with confidence through trusted quality controls, compliant solutions and deep healthcare expertise.
