Case Study: Moderna achieves rapid global COVID-19 vaccine rollout and stronger label compliance with Veeva Systems' Vault RIM

Moderna Streamlines Label Management with Veeva Vault RIM

Moderna, the biotech company behind one of the earliest and most effective mRNA COVID-19 vaccines, faced a critical regulatory challenge during its global rollout: managing rapidly multiplying local label variations and monthly Company Core Data Sheet (CCDS) updates using spreadsheets. As authorizations expanded across countries with different regulatory pathways, manual tracking became unsustainable and threatened timely distribution and compliance.

Working with Veeva, Moderna implemented Veeva Vault RIM’s label management functionality in an agile three-month rollout. The system automates labeling events, generates market-specific activities, and provides dashboards and reporting for global and local visibility, speeding updates and demonstrating compliance. As a result, Moderna scaled labeling operations to support approvals in 28 countries plus the EU, manage hundreds of label versions, and establish a robust foundation for future product launches.

Moderna

Colleen McGraw

Senior Director, Global Regulatory Labeling