Case Study: Moderna achieves faster, automated change control and streamlined regulatory–quality collaboration with Veeva Systems' Vault Quality to RIM Connection

How Moderna is Automating Change Control and Variation Management

Moderna, a leader in mRNA vaccines and therapies with a growing pipeline of some 40 programs, needed greater R&D agility to scale and collaborate across global teams. A major bottleneck was change control management: regulatory and quality groups relied on manual, disconnected processes and replicated assessments across systems and spreadsheets, causing delays, low transparency, and heightened compliance risk.

Moderna integrated Veeva Vault (Registrations and QMS) and implemented the Vault Quality to RIM Connection to automate change control and enable real‑time data transfer between regulatory and quality. The solution standardized workflows, created a clear audit trail, reduced duplication and inbox delays for regional impact assessments, lowered compliance risk, and improved cross‑team collaboration — freeing teams to make faster, better-informed decisions and focus on advancing therapies.

Moderna

Juhi Saxena

Associate Director of Regulatory and Clinical Platforms