CPMS CPMS Software Validation & Testing 2

Question 1

Which testing approach executes software without knowledge of its internal code structure?

Accepted Answer

Black-box testing

Answer

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?

Accepted Answer

Retesting previously validated functionality after a software change to ensure nothing broke

Answer

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?

Accepted Answer

Software with serious potential impact on product quality or patient safety

Answer

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?

Accepted Answer

To outline the scope, approach, resources, and schedule for validation activities

Answer

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?

Accepted Answer

A test designed under the most stressful or boundary conditions to reveal potential failures

Answer

Worst-case testing uses boundary and stress conditions most likely to expose failures, ensuring the software performs safely under challenging circumstances.

(CPMS) Certified Professional for Medical Software Practice Test

(CPMS) Certified Professional for Medical Software Practice Test

CPMS CPMS Software Validation & Testing 2