A test script is a documented set of instructions used to verify that a system function or requirement performs as intended. A script commonly defines the test objective, prerequisites, test data, actions, expected results, and the information required to record execution and the final outcome.
A well-designed script has a unique identifier and is traceable to the applicable requirement, risk, or assurance objective. Expected results should be specific and objectively assessable. For example, “The report displays the three approved batches with status Released” provides a clearer acceptance condition than “Verify the report is correct.”
Under the FDA’s Computer Software Assurance approach, the type and rigor of testing should be proportionate to intended use and process risk. Higher-risk functions generally require greater rigor, while functions that are not high process risk may be evaluated using scenario-based, exploratory, or other appropriately documented methods. Fully scripted testing is one option, not an automatic requirement for every high-risk function.
Test evidence should be sufficient to show what was evaluated, the result obtained, any issue identified, and the resulting conclusion. The level of detail should support objective review without creating documentation that adds little assurance value.
Frequently Asked Questions
Do all tests need a script under CSA?
No. The selected assurance method should reflect intended use and process risk. Scripted testing may be appropriate when repeatability and additional rigor are needed, while scenario-based or exploratory methods may be appropriate in other circumstances when justified and documented.
What makes a good test script?
A good test script is traceable to a defined requirement, risk, or objective; uses clear actions and objectively assessable expected results; identifies prerequisites and test data; and produces sufficient evidence for an independent reviewer to understand the outcome.
Are screenshots required for every test step?
No. Screenshots are not inherently required for every step. The record should contain sufficient objective evidence to demonstrate what was tested, the outcome, issues identified, and the conclusion, with the level of detail proportionate to risk.
Who approves test scripts?
Approval responsibilities should be defined in the validation plan or applicable procedure. QA may review or approve higher-risk scripted testing, while other assurance activities may be governed through approval of the overall approach, protocol, or execution record.