Software System Test Report
Summary
The Software System Test Report documents the execution results of your systematic testing approach, providing evidence that your medical device software meets all specified requirements. This report captures test outcomes, identifies any deviations, and demonstrates regulatory compliance through comprehensive documentation of verification activities.
Why is Software System Test Reporting important?
Software system test reporting provides objective evidence that your medical device software functions safely and effectively according to its specifications. This documentation is critical for regulatory submissions, as it demonstrates that you have systematically verified all software requirements and identified any issues before market release.
The test report serves as legal evidence of due diligence in software verification and provides traceability between requirements, test procedures, and actual results. Without proper test reporting, you cannot demonstrate compliance with software validation requirements or provide evidence that your software is safe for patient use.
Regulatory Context
Under 21 CFR Part 820.30(g) (Design Validation) and FDA Guidance “General Principles of Software Validation”:
- Test reports must provide objective evidence that software requirements are correctly implemented
- Documentation must demonstrate traceability from requirements through test results
- IEC 62304 requires documented evidence of software verification activities
- Test reports must support 510(k) submissions or other regulatory filings
Special attention required for:
- Complete documentation of test failures and their resolution
- Evidence of regression testing after defect fixes
- Verification of Software of Unknown Provenance (SOUP) integration
- Cybersecurity testing results for networked devices
Under 21 CFR Part 820.30(g) (Design Validation) and FDA Guidance “General Principles of Software Validation”:
- Test reports must provide objective evidence that software requirements are correctly implemented
- Documentation must demonstrate traceability from requirements through test results
- IEC 62304 requires documented evidence of software verification activities
- Test reports must support 510(k) submissions or other regulatory filings
Special attention required for:
- Complete documentation of test failures and their resolution
- Evidence of regression testing after defect fixes
- Verification of Software of Unknown Provenance (SOUP) integration
- Cybersecurity testing results for networked devices
Under EU MDR 2017/745 and EN ISO 13485:2016:
- Test reports must comply with IEC 62304:2006+A1:2015 documentation requirements
- Must provide evidence for technical documentation and CE marking
- Risk-based testing results must align with ISO 14971 risk management
- Reports must support notified body assessment of software verification
Special attention required for:
- Clinical evaluation integration for software with clinical claims
- Post-market surveillance data collection planning
- Essential requirements compliance demonstration
- Software as Medical Device (SaMD) verification evidence
Guide
Understanding Test Report Structure
Your software system test report must provide complete documentation of test execution, including test procedures followed, actual results obtained, and pass/fail determinations for each test case. The report should clearly link test results back to specific software requirements to demonstrate verification completeness.
Test execution summary provides an overview of testing scope, test environment, and overall results. Include the number of test cases executed, passed, failed, and any test cases that were skipped or deferred.
Individual test results must document each test case execution with sufficient detail to support regulatory review. Include test case identifier, requirement being verified, test procedure followed, actual results observed, and pass/fail determination.
Documenting Test Execution Details
For each test case, document the specific test environment used, including software versions, hardware configuration, test data, and environmental conditions. This information is crucial for result reproducibility and regulatory review.
Actual results documentation should capture what actually happened during test execution, not just whether the test passed or failed. Include screenshots, log files, measurement data, or other objective evidence of test outcomes.
Deviation documentation is critical when test execution differs from planned procedures. Document any deviations from the test plan, the reason for the deviation, and how the deviation affects test validity.
Handling Test Failures and Anomalies
When test cases fail, your report must document the failure investigation process and resolution. Include root cause analysis, corrective actions taken, and verification that fixes resolve the issue without introducing new problems.
Anomaly documentation should capture unexpected behaviors that don’t necessarily constitute test failures but may indicate potential issues. Document the anomaly, investigation results, and determination of whether further action is required.
Regression testing results must be documented when software changes are made to address test failures. Show that fixes resolve the original issue and don’t introduce new problems in previously working functionality.
Demonstrating Requirement Verification
Your test report must clearly demonstrate that all software requirements have been verified through testing. Use a traceability matrix or similar mechanism to show the relationship between requirements and test results.
Coverage analysis should identify any requirements that weren’t fully verified through testing and provide justification for alternative verification methods or acceptance of residual risk.
Risk verification should demonstrate that safety-related requirements and risk controls have been properly tested and function as intended.
Preparing for Regulatory Review
Structure your test report to facilitate regulatory review by organizing information logically and providing clear summaries. Include executive summaries that highlight key findings and overall verification status.
Supporting documentation should be referenced and available, including test procedures, test data, configuration information, and any tools or equipment used during testing.
Quality assurance review should be documented, showing that test results have been reviewed and approved by appropriate personnel before finalizing the report.
Example
Scenario: You have completed system testing for your diabetes management app that tracks blood glucose readings, calculates insulin dosing recommendations, and provides trend analysis. Testing covered functional verification, performance validation, safety testing, and integration with glucose meters and cloud services.
Your test execution revealed that 98% of test cases passed on first execution. Two test cases failed initially due to incorrect insulin calculation rounding, which was fixed and successfully retested. One performance test showed slower than expected cloud synchronization under poor network conditions, which was accepted as within acceptable limits after risk analysis.
Software System Test Report
Document ID: SSTR-001
Version: 1.0
Test Period: March 15-29, 2024
1. Executive Summary
System testing of DiabetesManager v2.1 has been completed successfully. Of 127 test cases executed, 125 passed and 2 initially failed but passed after defect correction. All software requirements have been verified, and the system is ready for release.
2. Test Execution Summary
Test Environment:
- Mobile Devices: iPhone 12 (iOS 16.3), Samsung Galaxy S21 (Android 12)
- Network: WiFi 802.11n, 4G LTE, limited connectivity simulation
- Test Glucose Meters: Accu-Chek Guide v1.2, OneTouch Verio v2.0
- Cloud Environment: AWS staging environment
Test Results Overview:
- Total Test Cases: 127
- Passed: 125 (98.4%)
- Failed (Initial): 2 (1.6%)
- Failed (Final): 0 (0%)
- Skipped: 0
3. Test Results by Category
3.1 Functional Testing (85 test cases)
- Glucose Data Management: 25/25 passed
- Insulin Calculation: 23/25 passed (2 initially failed, corrected and retested)
- Trend Analysis: 20/20 passed
- Device Integration: 17/17 passed
3.2 Performance Testing (22 test cases)
- Response Time: 20/20 passed
- Data Synchronization: 2/2 passed (1 with acceptable deviation)
- Battery Usage: 0/0 (deferred to hardware testing)
3.3 Safety Testing (20 test cases)
- Input Validation: 8/8 passed
- Error Handling: 7/7 passed
- Fail-Safe Behavior: 5/5 passed
4. Failed Test Cases and Resolution
| Test ID | Requirement | Failure Description | Root Cause | Resolution | Retest Result |
|---|---|---|---|---|---|
| TC-015 | REQ-005 | Insulin calculation 0.05 units off expected | Rounding algorithm error | Updated rounding logic in calculation module | PASS |
| TC-016 | REQ-005 | Insulin calculation incorrect for edge case | Missing boundary condition check | Added boundary validation | PASS |
5. Anomalies and Deviations
Anomaly AN-001: Cloud synchronization under poor network conditions (TC-089)
- Description: Sync time 8.2 seconds vs. expected <5 seconds
- Investigation: Network simulation more restrictive than real-world conditions
- Resolution: Accepted as within acceptable limits based on risk analysis
- Impact: No safety impact, user experience acceptable
6. Requirement Verification Status
All 45 software requirements have been successfully verified through system testing:
- Functional Requirements: 32/32 verified
- Performance Requirements: 8/8 verified
- Safety Requirements: 5/5 verified
7. Conclusions and Recommendations
System testing demonstrates that DiabetesManager v2.1 meets all specified requirements and is suitable for release. All critical safety functions operate correctly, and performance meets user needs. The software is recommended for production deployment.
Outstanding Actions: None
Approved by: [Test Manager], [Quality Assurance], [Project Manager]