Case Study: Alvotech achieves six-week eTMF go-live and improved compliance with Veeva Systems' Vault eTMF

Alvotech Fast-Tracks Collaboration and Compliance

Alvotech, a Reykjavik-based biotech with 1,000+ employees, faced growing complexity in its clinical trials and the limits of paper-based TMF management as it scaled and worked with multiple CROs and evolving regulations (including EU CTR and virtual inspections). The company needed an electronic system to track versions, metadata, and audit trails, maintain study archives, and demonstrate inspection readiness across sponsor and CRO-held documents.

Alvotech implemented Veeva Vault eTMF (leveraging existing Vault RIM and Quality suites) in six weeks with a focused five-person core team, hands-on training, dedicated support, and clear documentation. The validated system delivered version history, metadata and audit trails, reduced manual uploads and activity tracking, improved CRO collaboration and inspection readiness, and established a scalable operating model to support future growth.

Alvotech

Ruth Ruffieux

Head of Clinical Operations