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Process Validation Protocol Template

An Installation Qualification Template is used to complete the Process Validation protocol by properly documenting that the equipment/system is properly installed, delivered to specification and integrated with the calibration and maintenance systems of the manufacturing facility. This protocol includes a component checklist to assist the recorders to specify the component name, code number, function and, if applicable, the range(s) of variation. Upon receipt of equipment from a supplier, quality managers should use a checklist for acceptance testing to verify its reliability.

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Process Validation Protocol Template

Process Validation Protocol - Installation Qualification Template

Installation Qualification Protocol

Define the goal:

Which department/s is/are in charge?

define the responsibility:

System/Equipment

A general explanation of the function and main elements of the system/devices being installed

Attach relevant photos of the equipment/system

Supporting Utilities

Explanation of supporting utility:

Main Components

Component Name and ID:

Component Function:

What is/are the Area(s) of Deviation?

Requirement/Order of the Area(s) of Deviation

Actual

Influence on Operation

Justification for Acceptance

Deviations

Completion

Results:

Conclusions:

Name of the protocol author & signature:

Protocol Approval by (name and signature):

Quality Assurance Approval by (name and signature):

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