Case Study: Indian pharmaceutical manufacturer achieves 21 CFR Part 11 compliance with E Tech Group

Indian Pharmaceutical Manufacturer achieves full 21 CFR Part 11 compliance with E Tech Group

E Tech Group was engaged by an Indian pharmaceutical manufacturer facing compliance and operational challenges with its blister packaging line. The system's outdated PLC communications were unstable and lacked the data management capabilities required for 21 CFR Part 11 compliance, resulting in unreliable batch records and insufficient audit trails that risked regulatory audits.

To resolve this, E Tech Group modernized the control architecture by upgrading to Ethernet protocols, integrating machine vision for documentation, and implementing an Ignition SCADA system. This solution provided secure access control, reliable batch reporting, and enhanced audit traceability. The upgrade by E Tech Group successfully achieved full regulatory compliance, resolved PLC stability issues, and significantly improved the client's readiness for inspections through secure electronic recordkeeping.