Case Study: Arcus Biosciences achieves inspection readiness and streamlined submissions with Veeva Systems' Vault RIM

Arcus Biosciences Improves Inspection Readiness with Veeva Vault RIM

Arcus Biosciences, founded in 2015, is growing into a fully integrated biopharmaceutical company focused on immuno‑oncology. To prepare for scale and regulatory inspections, the company moved away from an uncontrolled patchwork of emails and SharePoint—where versioning, distribution control, audit trails, and standard processes were lacking—toward a validated regulatory information management (RIM) system.

Arcus selected Veeva Vault RIM (including Vault Submissions and Submissions Archive) and completed a three‑month remote implementation across six workstreams (IT, business process, system configuration, training, data migration, and validation). The rollout trained 60+ users, established a single secure authoritative source and auditable submission workflows, improved regulatory efficiency, and launched ongoing user forums and training to drive continuous improvement.

Arcus Biosciences

Lisa Owens

Senior Director of Regulatory Operations