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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

Process Validation Protocol - Installation Qualification Template Checklist

Created by: SafetyCulture Staff | Industry: General | Downloads: 3

An installation qualification template is used to complete the process validation protocol by properly documenting that the equipment/system is correctly installed, supplied as specified, and integrated in the manufacturing facility calibration and maintenance systems. This process validation protocol - installation qualification template contains components checklist to make it easier for protocol authors to specify component name, code no., function and area(s) of deviation, if any.

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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