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When programming a clinical chemistry analyser and you programmed the machine at 37 degree Celsius and the test was done at room temperature, any effects on the results? Going to be grateful with feedback.

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  • In all the validations I've done in the past (hundreds), we always mimicked the actual condition as close as possible. One great example was that we had one person do QC of a manufacturing process.

  • ching Nelson tsoine
    ching Nelson tsoine

    Thanks very much

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comment_95398

In all the validations I've done in the past (hundreds), we always mimicked the actual condition as close as possible.

One great example was that we had one person do QC of a manufacturing process. Only that one person. When they were out on leave, someone else performed the QC, and it failed. It failed with almost everyone because they did the process differently.

It's best to have the validation / qualification / quality control done under the same conditions in which it will be performed.

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