Posted on / by admin / in 21 CFR Part 11 SCADA, Pharmaceutical, SCADA

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
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