Synergistic Solutions

Biotech Automation Integration and Validation

Amgen Inc.
  • Operator Interface Replacement - Thousand Oaks, CA

  • Replaced existing PanelView 900 terminals with PanelView Plus 1000 terminals (26 PV's Replaced in total)

  • Generation of validation documents to conform to current GMP's:
    • Validation Plans (VP)
    • Requirements and Design (RD)
    • Development Tests (DT)
    • Installation and Operational Qualifications (IOQ)
    • Traceability Matrix (TM)

Validation Executing



  • FDA (Federal Drug Administration) adherence



  • Clean Room Manufacturing Environment

  • GMP (Good Manufacturing Practices) Regulated Practices

  • Final Product