Installation Qualifications are a collection of test cases used to verify the proper installation of a System. The requirement to properly install the system was defined in the Design Specification. Installation Qualifications must be performed before completing Operational Qualification or Performance Qualification.
Installation Qualifications 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
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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.
Depending on your needs and the complexity of the system, Installation Qualifications can be combined with Operational Qualification or Performance Qualification.
Installation Qualifications 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.
Frequently Asked Questions
Q: Can I see an example of a installation qualification?
A: We have an sample installation/operational qualification for an Excel spreadsheet available for download.
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Acronyms
Installation/Operational/Performance Qualification, Installation/Operational Qualification, Installation Qualification, IOPQ, IOQ, IQ
Additional Resources
Validation Document Resources
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