Bug Fix Report Template
Summary
The Bug Fix Report Template documents the evaluation and implementation of bug fixes according to your company’s change management process. It ensures that all software defects are properly analyzed, corrected, tested, and documented to maintain product safety and regulatory compliance.
Why is Bug Fix Report Template important?
Bug fix report templates are critical for maintaining consistent documentation of software defects and their resolution in your medical device software. Regulatory authorities require systematic documentation of all software changes, including bug fixes, to ensure that corrections don’t introduce new risks or compromise device performance. This template ensures standardized documentation that demonstrates your commitment to continuous improvement and helps maintain user trust by showing that identified issues are promptly and thoroughly addressed.
Regulatory Context
Under 21 CFR Part 820 (Quality System Regulation) and IEC 62304:
- Software problem resolution must be documented under IEC 62304 Chapter 9
- Changes require evaluation under 820.30(i) design controls
- Bug fixes must follow your change control procedures (820.30(i))
- Risk analysis must be updated if new risks are identified (820.30(g))
- Verification and validation may be required for significant fixes (820.30(f))
Special attention required for:
- Class B and C software where bugs could affect safety
- Changes that impact software requirements or architecture
- Bug fixes that require new or modified testing procedures
- Integration with your CAPA system for systematic issues
Under 21 CFR Part 820 (Quality System Regulation) and IEC 62304:
- Software problem resolution must be documented under IEC 62304 Chapter 9
- Changes require evaluation under 820.30(i) design controls
- Bug fixes must follow your change control procedures (820.30(i))
- Risk analysis must be updated if new risks are identified (820.30(g))
- Verification and validation may be required for significant fixes (820.30(f))
Special attention required for:
- Class B and C software where bugs could affect safety
- Changes that impact software requirements or architecture
- Bug fixes that require new or modified testing procedures
- Integration with your CAPA system for systematic issues
Under EU MDR 2017/745 and EN ISO 13485:2016:
- Software lifecycle processes must comply with IEC 62304:2006+A1:2015
- Changes require evaluation under Article 120 (significant change assessment)
- Bug fixes must be integrated with your quality management system (Article 10(9))
- Post-market surveillance data must inform bug identification and resolution
- Technical documentation must reflect current software state (Annex II)
Special attention required for:
- Assessment of whether bug fixes constitute significant changes
- Integration with post-market clinical follow-up requirements
- Notified body notification for significant software changes
- EUDAMED registration updates for software modifications
Guide
Documentation Requirements
Your Bug Fix Report Template must capture the complete lifecycle of a software defect from identification to resolution. Start with a unique bug ID that links to your existing tracking systems (like Jira or GitHub issues). This ensures traceability across your development and quality systems.
Document the bug thoroughly using the template fields to describe the specific software version affected, the conditions under which the bug occurs, and its impact on device functionality. Include details about user scenarios or system states that trigger the issue, as this information is crucial for both correction and prevention.
Corrective and Preventive Actions
Corrective actions describe how you will fix the immediate problem. Focus on the technical approach without revealing proprietary code details. Explain whether the fix involves code changes, configuration updates, or process modifications.
Preventive actions are equally important and demonstrate your commitment to continuous improvement. Consider whether additional testing, code reviews, or development process changes could prevent similar bugs. If existing processes already capture this type of issue, document why additional prevention isn’t necessary.
Requirements and Risk Analysis
Link bugs to software requirements when applicable. If the bug reveals a gap in your requirements, document whether new requirements should be added or existing ones modified. This connection helps maintain traceability between your requirements and testing.
Evaluate risks associated with both the bug and its fix. Use your existing risk assessment format to document any new risks or changes to existing risk controls. Consider both the risk of leaving the bug unfixed and any risks introduced by the correction.
Testing and Verification
Design specific tests to verify that your bug fix works correctly. These tests should demonstrate that the bug no longer occurs under the original conditions and that the fix doesn’t introduce new problems. Reference existing test procedures when possible, or create new ones following your established testing protocols.
Document test results thoroughly, including who performed the testing and when. Failed tests require additional corrective action, while passed tests provide evidence that your fix is effective.
Integration with Change Management
Connect your bug fix to your broader change management process. Reference your Change Management SOP and ensure that significant bug fixes trigger appropriate change evaluation procedures. This integration ensures that bug fixes receive proper review and approval before implementation.
Example
Scenario
Your diabetes management app crashes when users try to export their glucose data to PDF format. The bug occurs in version 2.1.3 and affects approximately 15% of users who attempt data export. A user reported this through your customer support system, and your development team has identified the root cause as a memory allocation issue in the PDF generation library.
Bug Fix Report Template Document
Bug ID: BF-2024-001
Date Bug Reported: 2024-03-15
Bug Description: Application crashes when users attempt to export glucose data to PDF format. The crash occurs during PDF generation and results in complete application termination. Users lose unsaved data and must restart the application. The issue affects the data export functionality which is used by patients to share information with healthcare providers.
Software Product and Version: DiabetesTracker Mobile App v2.1.3
Corrective Action: Replace the current PDF generation library (PDFKit v1.2.1) with an updated version (PDFKit v1.4.2) that includes memory management improvements. Implement additional error handling around PDF generation to gracefully handle memory constraints and provide user feedback if export fails.
Preventive Action: Add automated testing for PDF export functionality with large datasets to catch memory-related issues before release. Include PDF export testing in the usability evaluation protocol to ensure real-world usage patterns are tested. Update the software system test plan to include stress testing of export functions.
Relevant Software Requirements: SR-045: The system shall allow users to export glucose data in PDF format. The bug reveals that this requirement needs additional detail about error handling and memory constraints.
Relevant Risks:
| Risk ID | Hazard | Hazardous Situation | Harm |
|---|---|---|---|
| R-023 | Software crash during data export | User loses unsaved glucose readings | Delayed or incorrect treatment decisions |
Bug Software Test:
| SR ID | Test ID | Objective | Test Steps | Acceptance Criteria |
|---|---|---|---|---|
| SR-045 | T-PDF-001 | Verify PDF export works with large datasets | 1. Load app with 1000+ glucose readings 2. Navigate to export function 3. Select PDF format 4. Initiate export | PDF generates successfully without crash, file opens correctly |
Bug Software Test Results:
| SR ID | Test ID | Objective | Test Steps | Acceptance Criteria | Acceptable (Yes/No) | Comments |
|---|---|---|---|---|---|---|
| SR-045 | T-PDF-001 | Verify PDF export works with large datasets | 1. Load app with 1000+ glucose readings 2. Navigate to export function 3. Select PDF format 4. Initiate export | PDF generates successfully without crash, file opens correctly | Yes | Test passed on iOS and Android platforms |
Bug Test Date and Tester: 2024-03-22, Sarah Johnson (QA Engineer)
Additional Testing Required: Regression testing of all export formats (CSV, Excel) to ensure the library update doesn’t affect other export functions. Performance testing with various dataset sizes.
Updated Software Release: Version 2.1.4 scheduled for release 2024-04-01