The Installation Qualification Protocol verifies the proper installation and configuration of a System. This can include ensuring that necessary files have been loaded, equipment has been installed, the necessary procedures have been approved, or the appropriate personnel have been trained. The requirements to properly install the system were defined in the Design Specification. Installation Qualification must be performed before completing the Operational Qualification or Performance Qualification.
Depending on your needs and the complexity of the system, Installation Qualification can be combined with Operational Qualification or Performance Qualification.
Installation Qualification protocols should be approved before protocol execution. A copy of the unexecuted protocol should be kept in the validation package. The unexecuted protocol should be approved by the System Owner and Quality Assurance. The executed protocol should be signed by the tester and reviewed by the system owner and Quality.
Installation Qualification Examples
Installation Qualification might test:
- That the operating system has the appropriate processor, RAM, etc.
- That all files required to run the system are present
- That all documentation required to train system personnel has been approved
Each step of the qualification should include an instruction, an expected result, and the actual result. Any discrepancy between the expected result and the actual result should be tracked as a deviation. Deviations should be resolved before validation is complete.
Alternative Document Names and Acronyms
The following terms or abbreviations are sometimes used: Installation/Operational/Performance Qualification, Installation/Operational Qualification, Installation Qualification, IOPQ, IOQ, IQ.
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