Case Study: Mallinckrodt Pharmaceuticals achieves globalized, integrated quality management with MasterControl's web-based QMS

Mallinckrodt Baker’s Migration to Web-based MasterControl™ System Helps Globalize Company’s Quality Management

Mallinckrodt Baker Inc., a longtime producer of specialty and high‑purity chemicals for pharmaceutical, laboratory, microelectronic and industrial markets, operates multiple sites worldwide and must meet strict FDA and ISO quality standards. The company relied on paper files and an underperforming client/server document system, which limited global collaboration, slowed approvals and made it harder to maintain compliant, traceable quality processes as operations expanded.

MBI migrated to the web‑based MasterControl Documents and Forms suite in 2005, with Professional Services handling data migration, training and validation using MasterControl’s Validation ToolKit. The move automated document and change control, enabled global approvals and notifications, and improved revision tracking; users grew from about 50 to 300 and the system now stores ~3,000 documents. Auditors praised traceability and electronic signatures, ISO compliance was maintained, obsolete SOPs were reduced, and the new process earned internal recognition for operational excellence.

Mallinckrodt Pharmaceuticals

Gary Jerabek

Senior Quality Engineer