CPMS CPMS Software Validation & Testing 2 — Questions and Answers
Question 1: Which testing approach executes software without knowledge of its internal code structure?
- White-box testing
- Gray-box testing
- Black-box testing (Correct answer)
- Static analysis
Correct answer: Black-box testing
Black-box testing evaluates software functionality based solely on inputs and outputs without knowledge of internal code structure.
Question 2: What is regression testing in the context of medical software?
- Testing performed to verify fixes after a software defect is found
- Retesting previously validated functionality after a software change to ensure nothing broke (Correct answer)
- Testing that simulates worst-case usage scenarios
- Testing focused on software performance under load
Correct answer: Retesting previously validated functionality after a software change to ensure nothing broke
Regression testing re-executes previously passing tests after a software change to confirm that existing functionality has not been broken.
Question 3: Under FDA's software validation guidance, which category of software requires the most rigorous validation effort?
- Software with no impact on product quality
- Software with minor indirect impact on product quality
- Software with serious potential impact on product quality or patient safety (Correct answer)
- Software used only for administrative functions
Correct answer: Software with serious potential impact on product quality or patient safety
FDA guidance requires the most rigorous validation for software that could have a serious impact on product quality or patient safety.
Question 4: What is the role of a Validation Plan in medical software projects?
- To document defects discovered during testing
- To outline the scope, approach, resources, and schedule for validation activities (Correct answer)
- To record the final results of all validation test executions
- To list all software requirements gathered from stakeholders
Correct answer: To outline the scope, approach, resources, and schedule for validation activities
A Validation Plan defines the scope, strategy, resources, and schedule for all planned validation activities before testing begins.
Question 5: In medical software testing, what is a 'worst-case' test scenario?
- A test using the most experienced users to reduce errors
- A test designed under the most stressful or boundary conditions to reveal potential failures (Correct answer)
- A test that uses only invalid inputs to assess error handling
- A test that covers the most commonly used software features
Correct answer: A test designed under the most stressful or boundary conditions to reveal potential failures
Worst-case testing uses boundary and stress conditions most likely to expose failures, ensuring the software performs safely under challenging circumstances.
Question 6: Which document formally closes a medical software validation project and summarizes the validation outcomes?
- Validation Plan
- Test Protocol
- Validation Summary Report (Correct answer)
- Change Control Record
Correct answer: Validation Summary Report
The Validation Summary Report formally concludes the validation effort by summarizing test results, deviations, and a conclusion on whether the software is validated.
CPMS CPMS Software Validation & Testing 2
Which testing approach executes software without knowledge of its internal code structure?