COMMISSIONING
 
    Commissioning Plan Development
    System/Equipment Definition
    System/Equipment Start-up Checklist
    Scheduling/Coordination
    Systems Checkout/Debugging/Troublshooting
    Documentation
    Maintenance Training
    Operator Training
    Validation Turnover

 
 
  FIELD EXECUTION
 
 
    IQ/OQ/PQ Execution
    Process Validation
    Cleaning Validation
    Computer Validation
    Facility Qualification
    Vendor Acceptance Testing

 
 
  ENVIRONMENTAL MONITORING PROGRAM
 
 
    Determination of clean room classification
    Evaluation of criteria based on FS 209E, FDA Guide, EU Guide, WHO Guide
    Determination of alert and action limit by each clean room and/or classification
    Management of corrective action programs and problem solving

 
 
  START-UP
 
 
    Commissioning Test of HVAC in environmentally controlled areas
    Passivation and Sanitation of WFI Distribution System
    Participate in internal audit
    Process analysis to determine the state of a process and recommend
     the corrective actions needed tocontrol variation
    Establishment of Documentation System