IQ/OQ/PQ Final Report

When all installation, operational & performance testing has been completed, all exceptional conditions (if any) have been documented and resolved and all acceptance criteria have been met, the completed IQ/OQ/PQ protocol shall be circulated for post-execution approval, along with a final report.

The Final Report should provide a clear overview of the entire qualification execution, summarize the results obtained and document any discrepancies.

The order in which information is presented should be logical and easy to follow.

Use tools, such as tables, to help summarize results and findings. When writing any document or report, it is important to consider your audience.

The Final Report should address, at a minimum, the following elements:

1. Identification of the equipment / system.

2. A list of all test cases performed including whether those test cases passed.

3. A summary of the key results obtained during testing along with a discussion of any non-conformances (deviations) encountered, their impact, and how they were resolved.

4. A conclusion statement whether the system met the defined requirements of acceptance allowing for the release of the system.

Once the IQ/OQ/PQ and Final Report have been approved by all appropriate departments, the temperature mapping qualification of the CTU shall be considered completed and released for use.

Next Steps

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