Case Study: Teva Pharmaceutical Industries achieves accurate, efficient FDA compliance with MasterControl

MasterControl™ Facilitates Accurate, Efficient FDA Compliance at Teva USA

Teva Pharmaceuticals USA, a leading U.S. manufacturer of generic drugs, faced a slow, error-prone paper-based SOP and change-management process required for FDA compliance. Manual routing, overwritten files, cross‑facility restrictions and “document signature parties” made approvals cumbersome, increased risk of lost revision history, and lengthened approval cycles.

Teva selected MasterControl’s configurable electronic quality-management suite, migrating some 3,500 SOPs, validating the system to 21 CFR Part 11, and delivering phased training. The result: automated document control and revision tracking with full audit trails and electronic signatures, approval cycles shortened from months to weeks or days, eliminated manual signature logistics, and measurable time and cost savings while ensuring continued FDA compliance.

Teva Pharmaceutical Industries

Evjatar Cohen

Quality Assurance IT Project Manager