Test Script / Test Case
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
A documented, step-by-step procedure specifying the input, action, and predefined expected result for a single test within a qualification protocol or computerized system validation, executed and recorded — pass/fail, actual result, tester initials and date — as objective evidence that a requirement or specification was verified.
Each test script traces back to a specific line in the user requirements specification or functional specification, so that reviewers can confirm every requirement has at least one test covering it — the logic captured in a requirements traceability matrix. The expected result is written before the test is run, which is what makes the test objective: the tester is confirming a prediction, not describing whatever happened.
When an actual result does not match the expected result, that is a test failure or “incident,” handled through the site’s deviation or test-incident process rather than simply overwritten — the original entry, the discrepancy, and its resolution all remain part of the GxP record.
- —Expected result is fixed before test execution, not written after the fact
- —Traces to a specific requirement or specification line via the traceability matrix
- —Executed by trained, authorized personnel and signed/dated contemporaneously
- —A mismatch between actual and expected result is a documented incident, not a silent correction
- —Collectively, test scripts are the raw evidence underlying a qualification or validation summary report
GAMP 5 (2nd ed., 2022); EU GMP Annex 11; ASTM E2500-25
Frequently asked questions
What is Test Script / Test Case?
A documented, step-by-step procedure specifying the input, action, and predefined expected result for a single test within a qualification protocol or computerized system validation, executed and recorded — pass/fail, actual result, tester initials and date — as objective evidence that a requirement or specification was verified.
Which regulations cover Test Script / Test Case?
GAMP 5 (2nd ed., 2022); EU GMP Annex 11; ASTM E2500-25