CPMS Software Validation & Testing Flashcards

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

Answer: Black-box testing

Black-box testing evaluates software functionality based solely on inputs and outputs without knowledge of internal code structure.

What is regression testing in the context of medical software?

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.

Under FDA's software validation guidance, which category of software requires the most rigorous validation effort?

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.

What is the role of a Validation Plan in medical software projects?

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.

In medical software testing, what is a 'worst-case' test scenario?

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.

Which document formally closes a medical software validation project and summarizes the validation outcomes?

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.