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ExamsCAS-003Questions#348
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CAS-003 · Question #348

CAS-003 Question #348: Real Exam Question with Answer & Explanation

The correct answer is B: User acceptance testing. User acceptance testing (UAT) validates that a newly integrated COTS solution functions correctly alongside existing validated instruments under real operational conditions.

Question

A medical device company is implementing a new COTS antivirus solution in its manufacturing plant. All validated machines and instruments must be retested for interoperability with the new software. Which of the following would BEST ensure the software and instruments are working as designed?

Options

  • ASystem design documentation
  • BUser acceptance testing
  • CPeer review
  • DStatic code analysis testing
  • EChange control documentation

Explanation

User acceptance testing (UAT) validates that a newly integrated COTS solution functions correctly alongside existing validated instruments under real operational conditions.

Common mistakes.

  • A. System design documentation describes intended behavior but does not actively test or confirm interoperability after a change.
  • C. Peer review examines design or code artifacts and does not validate runtime interoperability between the antivirus software and instruments.
  • D. Static code analysis tests source code for defects and is not applicable to validating COTS binary software against existing instruments.
  • E. Change control documentation records and approves the change process but does not itself verify that software and instruments operate correctly together.

Concept tested. Validation testing for COTS software in regulated environments

Reference. https://www.fda.gov/media/73141/download

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