CPMS CPMS Software Validation & Testing 1 — Questions and Answers
Question 1: Which FDA guidance document specifically addresses software validation for medical devices?
- General Principles of Software Validation (2002) (Correct answer)
- 21 CFR Part 11
- ISO 13485:2016
- IEC 62304:2006
Correct 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.
Question 2: What is the primary purpose of Installation Qualification (IQ) in medical software validation?
- Verifying the software performs as intended under real-world conditions
- Confirming the software is installed correctly and meets design specifications (Correct answer)
- Testing user workflows against operational requirements
- Documenting software defects found during acceptance testing
Correct 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.
Question 3: In medical software validation, which testing phase confirms that the system meets end-user requirements in the actual production environment?
- Unit testing
- Integration testing
- User Acceptance Testing (UAT) (Correct answer)
- Regression testing
Correct 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.
Question 4: Which international standard defines the software development lifecycle requirements for medical device software?
- ISO 9001:2015
- IEC 62304:2006/AMD1:2015 (Correct answer)
- ISO 14971:2019
- IEEE 829
Correct answer: IEC 62304:2006/AMD1:2015
IEC 62304:2006 (amended 2015) defines the lifecycle requirements for medical device software development, maintenance, and risk management.
Question 5: What does a traceability matrix in medical software validation primarily demonstrate?
- The timeline of the validation project
- Linkage between user requirements, design specifications, and test cases (Correct answer)
- The hierarchy of software development team roles
- Defect density across software modules
Correct 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.
Question 6: During Operational Qualification (OQ) of medical software, what is being primarily verified?
- That the software is installed in the correct environment
- That the software performs as intended across its operating range (Correct answer)
- That the software meets user needs in production
- That the software source code is free of vulnerabilities
Correct 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.
CPMS CPMS Software Validation & Testing 1
Which FDA guidance document specifically addresses software validation for medical devices?