SOP on Installation Qualification

SOP on Installation Qualification

1.0 Objective: To check and document that the equipment installed conforms to purchase specifications and the manufacturer’s specifications.

2.0 Scope: to be performed at time of installation, modification, or relocation. 

3.0 Responsibilities: Service engineer & Quality Assurance staff are responsible to perform the installation qualification and record the information.

4.0 Materials, Equipment and Documents: 

1. List of the main components.
2. Description of required supporting utilities.
3. Operating manual.

5.0 Procedure:

5.01 Check and document that the equipment conforms to purchase specifications.
5.02 Record any deviations to the equipment.
5.03 Prepare a deviation report including the justification of acceptance and impact on the function.
5.04 Prepare an installation qualification report.

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