Case Study: Elekta achieves regulatory compliance and instant audit readiness with Dassault Systèmes ENOVIA

Ensuring compliance to regulations with ENOVIA

Elekta, a global leader in radiation therapy with about 2,500 employees, faced a major compliance and audit challenge: managing vast amounts of product and process data and rapidly producing documentation for regulators. To replace an unworkable paper-based approach, Elekta turned to Dassault Systemes and implemented the ENOVIA PLM solution.

Dassault Systemes delivered ENOVIA (including Engineering Central and Designer Central) as a single digital source of truth, consolidating engineering data, BOMs and change processes across Elekta’s global teams and partners. The deployment unified collaboration, made documents immediately accessible for audits, saved significant time locating records, and produced measurable compliance outcomes—most notably a successful FDA audit that praised Elekta’s excellent control over its information; Elekta is now expanding use and preparing to transition to ENOVIA V6.

Elekta

Bo Nilsson

Manager R&D