21CFR Part 11 Compliant Fermentation Control and Monitoring System
21CFR Part 11 Compliant Fermentation Control & Monitoring System
Customer Requirement
- Fermentation control system with 21CFR part 11 compliance
- Audit trail, report, alarm, graphic etc. as per 21CFR part 11
- DQ, IQ, OQ and validation
- Long term service and support
Systems and Tools
- Masibus PID controller 5040
- Citect SCADA -21 CFR part 11 compliance
- Fully wired panel with IT and networking components
Project Scope
- Supply, development, testing, commissioning, training, documentation & hand-over