Validation of Chromatography Data Systems: Meeting Business and Regulatory Requirements

Under the PQ test plan are the test scripts used to test the CDS application. These are the heart of any PQ testing effort and will take some time and effort to draft and to ensure that they are correct. The concept is that the test script will form the instruction set, the testing log, the archive for the actual testing and all experimental data and output will be recorded or logged here. The structure, based on the same IEEE standard as the test plan above, is shown in Table 18. Each test script (the whole document) can consist of one or more test procedures.
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Each test procedure typically consists of many test steps or operator instructions on how to perform the test. These test steps and test procedures will test the requirements documented in the URS. We will look at the examples of test procedures in Tables 21 23.
| Test steps and expected results | |
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| Test steps | Expected result |
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