API Reactor Data Acquisition Monitoring & 21CFR Part 11 Compliant System
Pharma API Reactor Data Acquisition Monitoring and 21CFR Part 11 Compliant System
Customer Requirement
- Pharma API reactor data acquisition monitoring with 21CFR part 11 compliance
- Audit trail, report, alarm, graphic etc. as per 21CFR part 11
- No data loss even in case of communication failure
- DQ, IQ, OQ and validation
- Long term service and support
Systems and Tools
- Masibus make Indicator LC5296 and RPM indicator with RS485 Modbus RTU
- Citect SCADA and historian-21 CFR part 11 compliance
- Schneider SCADA pack RTU for data logging and backfill in SCADA in case of communication failure
- Fully wired panel with IT and networking components
Project Scope
- Supply, development, testing, commissioning, training, documentation & hand-over