Validation of Chromatography Data Systems: Meeting Business and Regulatory Requirements

14.4: PQ Test Scripts

14.4 PQ Test Scripts

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.

Table 18: Outline of a test script (adapted from IEEE Standard 82965)
  1. Purpose of the test script

  2. Features to be tested

  3. Test execution instructions

  4. Identification of personnel

  5. Test procedure(s). Each of which consist of the following elements:

    • Test steps

    • Expected results

    • Space to document any observed results during test execution

    • Documented evidence

    • Acceptance criteria

  6. Test execution log

  7. Test summary log

  8. Testing conclusions and sign-off

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.

Table 21: Test script execution instructions written for a new user of an application

Test steps and expected results

Test steps

Expected result

  1. The system administrator defines user Security as user type Guest

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