Case Study: Endo Pharmaceuticals Inc. achieves streamlined, risk-based validation and rapid Vault adoption with Veeva Systems

Endo Pharmaceuticals Simplifies Validation with a Risk-Based Approach

Endo Pharmaceuticals, a US-based biopharma, faced inefficient, high-risk validation after its first Veeva Vault implementation: teams duplicated testing, scope creep grew, and exhaustive release validation prevented the company from adopting new features and innovations.

Endo implemented a GAMP‑5–inspired, risk‑based three-step approach—vendor quality assessment to trust Veeva’s work, impact classification for releases (review webinars, change control, URS impact assessments), and a scored governance process to cap enhancement impact—leveraging Veeva documentation to avoid redundant tests. The result: streamlined validation, reduced testing burden, maintained compliance, and the ability to launch three additional Vault products in six months (versus industry benchmarks of ~36 months), freeing bandwidth to adopt new capabilities.

Endo Pharmaceuticals Inc.

Joanna Ollendorff

Associate Director, Computer Systems Validation