CPMS Software Validation & Testing Flashcards

Which FDA guidance document specifically addresses software validation for medical devices?

Answer: General Principles of Software Validation (2002)

FDA's General Principles of Software Validation (2002) is the primary guidance for validating software used in medical devices.

What is the primary purpose of Installation Qualification (IQ) in medical software validation?

Answer: Confirming the software is installed correctly and meets design specifications

IQ confirms that the software and its hardware environment are installed correctly and meet defined design specifications before operational testing begins.

In medical software validation, which testing phase confirms that the system meets end-user requirements in the actual production environment?

Answer: User Acceptance Testing (UAT)

User Acceptance Testing (UAT) validates that the software meets end-user requirements and performs correctly in the actual production environment.

Which international standard defines the software development lifecycle requirements for medical device software?

Answer: IEC 62304:2006/AMD1:2015

IEC 62304:2006 (amended 2015) defines the lifecycle requirements for medical device software development, maintenance, and risk management.

What does a traceability matrix in medical software validation primarily demonstrate?

Answer: Linkage between user requirements, design specifications, and test cases

A traceability matrix maps user requirements to design specifications and corresponding test cases, demonstrating complete validation coverage.

During Operational Qualification (OQ) of medical software, what is being primarily verified?

Answer: That the software performs as intended across its operating range

OQ verifies that the software performs as intended across its specified operating range, confirming functional performance before production use.