Alcon: Achieving UDI Compliance with Veeva RIM

With increasing pressure to adapt to EUDAMED’s UDI module, medtech leaders are rethinking how they manage critical regulatory data and processes within their organizations. At the recent Veeva MedTech Summit, Leane Hinds, manager of regulatory intelligence for product ID at Alcon, presented her team’s journey to streamline UDI compliance with Veeva RIM. Her insights provide a valuable roadmap for medtech organizations navigating similar challenges.

Shifting from legacy processes to a unified RIM approach

Alcon’s initial approach to UDI compliance relied on fragmented systems that each handled a different stage of the submission lifecycle and required reprogramming with every new EUDAMED release. Manual data transfers increased the risk of errors and the systems were difficult to navigate for non-technical users. To overcome these obstacles and establish a more sustainable foundation for UDI compliance, Alcon decided to deploy UDI capabilities in Veeva RIM.

Their first step was to establish clear definitions for UDI data attributes and implement standardized data management practices. This ensured data consistency and accuracy across the organization. Next they focused on streamlining workflows for UDI data collection, verification, submission, and ongoing maintenance. This involved automating tasks where possible and minimizing manual data handling.

Unifying data and processes within a single platform enhanced data integrity, streamlined workflows, and improved communication and collaboration among regulatory teams and other stakeholders. As Hinds summarized, “We have all of our source and submission information in one system that involves fewer handoffs and is more controlled because it falls into well-established processes that we were already using with Veeva RIM.”

Sharing lessons learned

Reflecting on Alcon’s experience, Hinds shared several best practices for other medtechs embarking on a similar journey:

• Prioritize data governance: Establish a strong foundation for data governance by clearly defining data attributes, implementing standardized data management procedures, and ensuring data quality.
• Map the data landscape: Conduct a thorough assessment of existing data sources, formats, and locations to plan an effective data migration and integration strategy.
• Invest in user training and change management: Provide comprehensive training and support to ensure user adoption and proficiency with the new system. Effective change management is crucial for minimizing disruption and maximizing the benefits of the transformation.
• Emphasize data validation and accuracy: Implement robust data validation processes and quality checks to ensure the accuracy and reliability of UDI data.
• Thoroughly test system functionality: Conduct comprehensive testing across various scenarios and product types to identify and resolve any potential issues before go-live.

With required submissions starting in January 2026, it’s crucial for medtech organizations to begin preparations for EUDAMED UDI and work with a trusted technology partner to stay in compliance. As Hinds emphasized “EUDAMED is a huge, complicated undertaking, so be sure you sufficiently plan for implementation and then for continued maintenance.” To hear more details about Alcon’s UDI journey, watch Alcon: Achieving UDI Compliance with Veeva RIM on Veeva Connect.