Validation

  • Document Matrix
  • Master Validation Plan
  • Quality Plan
  • Project Plan
  • User Requirement Specification
  • Functional Design Specification
  • Software Design Specification
  • Hardware Design Specification
  • Module Design Specification
  • Lot Data System
  • Motion System
  • Measurement System
  • Recipe Management
  • Reporting System
     
  • Requirement Trace Matrix
  • Source Code Review
  • Module Testing (Test Scripts)
  • Factory Acceptance Test
  • Site Acceptance Test
  • Installation Qualification Protocol
  • IQ Report
  • Operation Qualification Protocol
  • OQ Report
  • Performance Qualification Protocol
  • PQ Report
  • OEM Manual
  • Control Schematics
  • Control Panel Drawings
     
  • Equipment Assembly Drawings
  • Fixture Drawings
  • Bill of Materials
  • Spare Parts List
  • PLC Program
  • HMI Program
  • Standard Operating Procedures
  • Back-Up and Restore
  • Diaster Recovery Procedure
  • Design Review
  • Risk Assessment (FMEA)
  • Design FMEA
  • System FMEA