Case Study: IRE (Institute for Radioelements) achieves autonomous quality management and long-term cost control with Ennov

Skills Transfer during QMS Implementation to Ensure Long-Term Cost Control

IRE (Institute for Radioelements), a world leader in radioisotope production, faced a complex quality challenge: operating at the intersection of pharmaceutical and nuclear regulations (GMP, ISO 9001/17025/14001, Eudralex, FDA) and needing a robust quality management and document management solution for ~250 users. IRE selected Ennov—specifically the Ennov platform/Ennov Doc—because of its industry reputation, flexible configuration to meet both pharmaceutical and nuclear requirements, and a transparent, trust-building project approach.

Ennov deployed Ennov Doc using iterative design sprints, focused training, clear documentation, and consultant-guided best practices to transfer skills to IRE’s quality and IT teams. The result was rapid establishment of operational routines, immediate post‑go‑live stability with no adjustment period, and genuine autonomy—IRE configured new modules themselves (e.g., training management), plans to manage its contract library, and reduced reliance on external support, delivering measurable long‑term cost control and resource savings.

IRE

Axelle Dufour

Project Manager