Life Sciences

Discover the true cost of compliance violations and how much time your team loses to manual documentation. Learn how leading pharmaceutical manufacturers are eliminating audit risks with automated systems that transform regulatory requirements from a burden into a competitive advantage. 

GOT operator terminals provide FDA 21 CFR Part 11 compliant operation with electronic signature capability, biometric authentication, and automatic audit trail generation. Role-based access control with encrypted communication ensures only authorized personnel can execute critical functions, while every action is timestamped and logged in tamper-proof records.

GENESIS data analysis platform with built-in industrial historian automates electronic batch records through real-time and historical data collection from all production systems. Automated report generation for regulatory submissions and centralized audit trail management eliminate manual paperwork without requiring third-party data loggers.

MELSEC control systems provide GAMP5 (Good Automated Manufacturing Practice 5) validated automation for compliant operations. Pre-validated modules accelerate implementation, IEC 62443-4-2 compliant security prevents unauthorized access, and comprehensive documentation packages support regulatory submissions and audits.

MELSOFT VIXIO vision inspection system enables 100% inspection coverage with AI-powered image analysis that detects both known defects and unexpected anomalies without extensive defect training. Inspection results automatically link with PLC manufacturing data - timestamps, batch information, process parameters - providing the visual evidence and traceability that regulatory audits demand.