This case study shows how a global radiopharmaceutical leader transformed its quality management system by harmonizing quality processes across more than 15 manufacturing sites in five countries while meeting both nuclear safety and pharmaceutical GxP requirements.
By partnering with Ennov, the organization replaced paper-based processes with a unified QMS software platform that strengthened document control, standardized deviations, CAPAs, complaints, audits, and change controls, and improved traceability through automated, audit-ready workflows.
The solution also integrated with the organization’s quality document management software, providing centralized control of SOPs, controlled documents, and quality records while ensuring employees always worked from the latest approved documentation. As regulatory requirements evolved, the company benefited from stronger governance, simplified compliance, and improved inspection readiness through electronic signatures and 21 CFR Part 11 compliance.
By connecting quality processes with broader compliance operations, the organization established a scalable quality management system software platform capable of supporting SaaS adoption, advanced analytics, continued site expansion, and future integration with regulatory information management software to streamline quality and regulatory activities across the enterprise.
The result was a modern digital quality foundation that increased operational efficiency, improved visibility across manufacturing sites, and enabled the organization to keep pace with the demands of a highly regulated, time-critical industry.