Process Validation Protocol - Installation Qualification Template

• Manufacturer

• Manufacturing Facility
  Address

• Equipment/System

• Protocol Author

• Conducted on

  Date

Installation Qualification Protocol

• Objective

• Scope

• Responsibility

System/Equipment

• General description of the function and main components of the system/equipment being installed

• Take/attach relevant photos of the equipment/system

  Media
Supporting Utilities

• Description of Supporting Utility

Components Checklist

Main Components

• Component Name & Code No.

• Component Function

• Select Area(s) of Deviation

  Select Model/Serial No. Specification Manual Drawing Wiring/Cabling Power/Fusing SOP (Operation) SOP (Maintenance) SOP (Calibration) Input/Output Control Environment Test Equipment of Instruments Utilities and Service Spare Parts List, Part Number and Supplier Other None

  • Model/Serial No.
  • Specification
  • Manual
  • Drawing
  • Wiring/Cabling
  • Power/Fusing
  • SOP (Operation)
  • SOP (Maintenance)
  • SOP (Calibration)
  • Input/Output Control
  • Environment
  • Test Equipment of Instruments
  • Utilities and Service
  • Spare Parts List, Part Number and Supplier
  • Other
  • None

• Model/Serial No. Requirement/Order

• Actual

• Justification for Acceptance

• Impact on Operation

• Specification Requirement/Order

• Actual

• Deviations

• Justification for Acceptance

• Impact on Operation

• Manual Requirement/Order

• Actual

• Deviations

• Justification for Acceptance

• Impact on Operation

• Drawing Requirement/Order

• Actual

• Deviations

• Justification for Acceptance

• Impact on Operation

• Wiring/Cabling Requirement/Order

• Actual

• Deviations

• Justification for Acceptance

• Impact on Operation

• Power/Fusing Requirement/Order

• Actual

• Deviations

• Justification for Acceptance

• Impact on Operation

• SOP (Operation) Requirement/Order

• Actual

• Deviations

• Justification for Acceptance

• Impact on Operation

• SOP (Maintenance) Requirement/Order

• Actual

• Deviations

• Justification for Acceptance

• Impact on Operation

• SOP (Calibration) Requirement/Order

• Actual

• Deviations

• Justification for Acceptance

• Impact on Operation

• Input/Output Control Requirement/Order

• Actual

• Deviations

• Justification for Acceptance

• Impact on Operation

• Environment Requirement/Order

• Actual

• Deviations

• Justification for Acceptance

• Impact on Operation

• Test Equipment of Instruments Requirement/Order

• Actual

• Deviations

• Justification for Acceptance

• Impact on Operation

• Utilities and Service Requirement/Order

• Actual

• Deviations

• Justification for Acceptance

• Impact on Operation

• Spare Parts List, Part Number and Supplier Requirement/Order

• Actual

• Deviations

• Justification for Acceptance

• Impact on Operation

• Specify Requirement/Order

• Actual

• Deviations

• Justification for Acceptance

• Impact on Operation

Completion

• Installation Qualification Results

• Conclusions

• Protocol Author & Signature

  Sign

• Protocol Approval by

  Sign

• Quality Assurance Approval by

  Sign