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 might test:
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.
For more examples, see our installation qualification template.
For an example of protocol execution, see our FastVal Electronic Protocol Execution.
Q: What is the definition of Installation Qualification?
A: The FDA definition of installation qualification is: Establishing confidence that process equipment and ancillary systems are compliant with appropriate codes and approved design intentions, and that manufacturer recommendations are suitably considered. In practice, the installation qualification is the executed test protocol documenting that a system has the necessary prerequisite conditions to function as expected.
Q: Can I see an example of an installation qualification?
A: We have a sample installation/operational qualification for an Excel spreadsheet available for download.
Q: Can I execute installation qualification test cases using MS Word or MS Excel?
A: When electronic systems are used to perform regulated processes (like the verification of validation test protocols), they need to be compliant with 21 CFR 11. MS Word and MS Excel do not, in their out-of-the-box state, have the necessary technological controls, like individual user passwords or audit trails, required to be compliant with electronic records requirements such as 21 CFR 11 or Annex 11. Ofni Systems recommends that organizations do not perform installation validation with non-compliant software like MS Word and MS Excel.
Q: How does Ofni Systems document validation testing?
A: At Ofni Systems, we use FastVal to execute test protocols electronically. This allows us to execute protocols to ensure requirement traceability and to generate the actual requirement traceability document. Other organizations might use Excel spreadsheets to keep a table of requirements, despite this being extremely difficult to maintain manually.
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The following terms or abbreviations are sometimes used: Installation/Operational/Performance Qualification, Installation/Operational Qualification, Installation Qualification, IOPQ, IOQ, IQ.