Case Study: Smith+Nephew achieves streamlined eTMF migration and improved data integrity with Veeva Systems' Vault eTMF

Preparing for data migration to improve data quality and governance

Smith+Nephew, a global medical technology leader operating in 100+ countries, faced complex clinical operations—managing 70+ studies across 400 sites—using manual, Excel-based processes, third‑party study builds, and a legacy TMF disconnected from their CTMS. This caused document backlogs, low internal adoption, and risk to audit readiness, while the team needed to migrate large volumes of legacy data and retain audit history.

They partnered with Veeva to deploy Vault eTMF using a phased, sprint-based approach with out-of-the-box configuration, iterative reviews, dry runs, intensive admin training, and a bespoke middleware-led migration executed in waves. The rollout preserved data integrity and audit history, reduced duplicate documents with TMF Bot, consolidated QC and filing, enabled independent site builds, unified eTMF/CTMS for KPI visibility, and successfully migrated critical studies and documents—improving governance, efficiency, and transparency.

Smith+Nephew

Lois Spencer

IT Transformation Lead