Case Study: U.S.-based Contract Research Organization (CRO) achieves audit-ready, Part 11‑compliant quality and competitive advantage with ZenQMS

U.S. Based Contract Research Organization - Customer Case Study

U.S. Based Contract Research Organization, a cancer-focused CRO founded in the early 1980s, needed a best-in-class Quality Management System to meet frequent client audits and potential FDA inspection. The CRO had struggled with a manual, paper-based system and an earlier online tool that required duplicating records to meet Part 11 requirements, so they sought a validated, Part 11‑compliant eQMS.

In 2017 the CRO selected and deployed ZenQMS, rolling the SaaS/Cloud eQMS out to 150+ employees; users praised its simplicity and global accessibility. ZenQMS streamlined training record management, enabled fast report and dossier generation, helped the company avoid audit findings related to training documentation, and provided a validated system that the business development team cites as a competitive advantage when winning new clients.