Case Study: Actelion achieves compliance and efficiency with MasterControl (Quatro)

Actelion’s Quatro System MasterControl by Any Other Name Stands for Compliance and Efficiency

Actelion is a global biopharmaceutical company based near Basel, Switzerland, known for therapies for pulmonary conditions and Gaucher disease. Facing strict FDA, EU and other regulatory requirements, the company had been operating two separate systems for document and training management that required manual synchronization, Excel tracking, wet signatures and offered limited reporting and no role‑based access—making compliance oversight slow and cumbersome.

In 2011 Actelion replaced the dual setup with Quatro (MasterControl integrated Documents and Training), building a centralized, web‑based QMS used by about 2,600 users. Quatro delivered role‑based access, electronic signatures, automated publication and training workflows, single sign‑on, and improved search and reporting—streamlining review and approval, strengthening GMP/GLP/GCP compliance, and boosting overall efficiency; Actelion is now extending the platform with CAPA and Audit integrations.

Actelion Pharmaceuticals

Rudi Frank

Head Quality Management