I don’t like the term validation deviation, preferring to use discrepancy to cover the errors or failures that occur during qualification/validation, such as when the actual results of a test step in a protocol do not match the expected results. These discrepancies can arise for various reasons, including errors in the protocol, execution issues, or external factors.
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I don’t like using the term deviation as I try to avoid terms becoming too overused in too many ways. By choosing discrepancy it serves to move them to a lower order of problem so they can be addressed holistically.
Validation discrepancies really get to the heart of deciding whether the given system/process is fit-for-purpose and fit-for-use. As such, they require being addressed in a timely and pragmatic way.
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And, like anything else, having an effective procedure to manage is critical.
![](https://investigationsquality.com/wp-content/uploads/2024/06/image-8.png?w=1024)
Validation discrepancies are a great example of building problem-solving into a process.