Process Validation Protocol - Installation Qualification Template

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

  • Supporting Utilities
  • Description of Supporting Utility

Components Checklist

    Main Components
  • Component Name & Code No.

  • Component Function

  • Select Area(s) of Deviation

  • 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

  • Protocol Approval by

  • Quality Assurance Approval by

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