Case Study: CSL Behring and CSL Limited achieve rapid, FDA-compliant H1N1 vaccine bottling and secure 21 CFR Part 11 data logging with Mitsubishi Electric Iconics Digital Solutions

CSL Behring and CSL Limited - Customer Case Study

CSL Behring and CSL Limited, a global vaccine manufacturer, needed to rapidly produce and package an H1N1 pandemic vaccine in Marburg, Germany while meeting US FDA 21 CFR Part 11 requirements for electronic records, signatures and long-term auditability under a $180M HHS contract. Mitsubishi Electric Iconics Digital Solutions was engaged to provide a validated automation and data-recording platform, deploying the ICONICS GENESIS32 software suite (DataWorX32, TrendWorX32, WebHMI, AlarmWorX32 and OPC DataStore) to ensure reliable logging, audit trails and secure electronic signatures.

Mitsubishi Electric Iconics Digital Solutions implemented an enterprise-wide solution across 23 servers (Windows Server 2003, SQL Server 2005, Kepware OPC) providing historian storage, alarm management, secure WebHMI access and TrendWorX32 reporting, supporting 109 simultaneous users. The system delivered 42-year-compliant recordkeeping, faster detection and documentation of abnormal conditions, and efficient, FDA-compliant bottling and packaging of H1N1 vaccine—enabling CSL to meet regulatory demands and fulfill its U.S. supply commitments.

CSL Behring and CSL Limited