| Comment Record |
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Commentor |
Mr. Wolfgang Winter |
Date/Time |
2001-12-21 09:08:01 |
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Organization |
Agilent Technologies Deutschland GmbH |
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Category |
Company |
| Comments for FDA General |
| Questions |
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1. General Comments
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Section 5.4.3 How test results should be expressed
Discussion:
The paragraph does not adequately reflect that test cases and test results must be documented together.
The requirement for quantitive vs. qualitative test results is stated in an ambiguous way. Qualitative (pass/fail) information is important to document and review test status and progress during the validation phase. A test result has to be either pass or fail based on the quantitative measurements obtained during execution of the associated test case and the acceptance limits.
Recommendation:
Reword the paragraph to state
Quantifiable test results should be recorded using the measured, quantitative result, the acceptance criteria as well as a qualitative result such as Pass/Fail information.
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