Case Study: Edwards Lifesciences achieves enterprise-wide eTMF adoption and increased efficiency with Veeva Systems

How Edwards Lifesciences developed a multi-part structure to facilitate successful eTMF adoption, collaboration, and management

Edwards Lifesciences, a global medical‑device company focused on heart valve and critical care technologies, implemented Veeva Vault eTMF in 2015 but faced low user adoption, difficulty locating correct document versions, and uneven collaboration across functions and time zones—issues that were intensified by the shift to remote work during the pandemic.

Partnering with Veeva MedTech, Edwards launched a multi‑part change program: a cross‑functional TMF Governance Board, the OneTMF initiative to assign document ownership to SMEs across functions and regions, a DIA‑based TMF Index for standardized guidance, annual user summits, and support for remote/hybrid roles. The approach increased accountability and adoption, reduced missing or incorrect documents, sped document routing and issue resolution, boosted engagement (summit attendance grew from ~100 to ~300), and created a sustainable foundation for compliant, enterprise‑wide eTMF management.

Edwards Lifesciences

Brenda DeJesus

Senior Manager, Clinical System Operations