R-TF-012-038 Verified Version Release
Document Information
| Field | Value |
|---|---|
| Product Name | |
| Version | |
| Release Date | |
| Document Prepared By | |
| Document Prepared Date | |
| Reviewed By | |
| Review Date | |
| Approved By | |
| Approval Date |
1. Release Identification
1.1 Software Product Information
| Field | Value |
|---|---|
| Product Name | |
| Version Number | |
| Build Number | |
| Release Type | ☐ Major Release ☐ Minor Release ☐ Patch ☐ Hotfix |
| Release Date | |
| Previous Version |
1.2 Release Scope
New Features:
- [Feature 1]
- [Feature 2]
Enhancements:
- [Enhancement 1]
- [Enhancement 2]
Bug Fixes:
- [Bug fix 1]
- [Bug fix 2]
Known Limitations:
- [Limitation 1]
- [Limitation 2]
2. Verification Completeness
2.1 Verification Activities Completed
| Activity | Reference Document | Status | Completion Date |
|---|---|---|---|
| Software Requirements Specification | R-TF-012-028 | ☐ Complete | |
| Software Architecture Design | R-TF-012-029 | ☐ Complete | |
| Software Test Plan | R-TF-012-033 | ☐ Complete | |
| Software Test Description | R-TF-012-034 | ☐ Complete | |
| Unit Testing | ☐ Complete | ||
| Integration Testing | ☐ Complete | ||
| System Testing | ☐ Complete | ||
| Regression Testing | ☐ Complete | ||
| Software Test Report | R-TF-012-035 | ☐ Complete | |
| Risk Management Activities | R-TF-013-002 | ☐ Complete |
2.2 Verification Results Summary
Total Requirements Verified: _
Requirements Coverage: _%
Total Tests Executed: _
Tests Passed: _
Pass Rate: ___%
Test Coverage:
- Code Coverage (Line): ___%
- Code Coverage (Branch): ___%
Verification Status: ☐ Pass ☐ Pass with Observations ☐ Fail
3. Software Configuration
3.1 Software Configuration Items
| Configuration Item | Version/Identifier | Repository Location | Commit Hash |
|---|---|---|---|
3.2 SOUP Components
| SOUP Name | Version | Purpose | License | Verified |
|---|---|---|---|---|
| ☐ Yes |
For detailed SOUP information, see SOUP Directory.
3.3 Build Information
Build Environment:
- Build Tool: [Name and version]
- Build Date/Time: [Date and time]
- Build Location: [Environment]
- Build Responsible: [Name]
Build Script/Procedure: [Reference or description]
Build Verification:
- ☐ Build completed successfully
- ☐ Build artifacts generated
- ☐ Build reproducible
- ☐ Build integrity verified (checksums)
4. Residual Anomalies
4.1 Known Residual Anomalies
| Anomaly ID | Summary | Severity | Impact on Use | Risk Assessment | Acceptance Rationale |
|---|---|---|---|---|---|
| ☐ Acceptable |
☐ No residual anomalies
4.2 Risk Evaluation of Residual Anomalies
Risk Evaluation Performed: ☐ Yes ☐ No ☐ N/A
Risk Evaluation Results:
[Provide summary of risk evaluation demonstrating that residual anomalies do not result in unacceptable risk]
References:
- Risk Management Record: R-TF-013-002
- Software Test Report: R-TF-012-035
Conclusion:
☐ All residual anomalies have been evaluated and determined not to contribute to unacceptable risk
☐ Residual anomalies require additional risk control measures before release
☐ N/A - No residual anomalies
5. Software Release Package
5.1 Release Artifacts
| Artifact | Filename/Location | Checksum (SHA-256) | Status |
|---|---|---|---|
| Executable/Deployable | ☐ Verified | ||
| Installation Package | ☐ Verified | ||
| Configuration Files | ☐ Verified | ||
| Database Scripts | ☐ Verified | ||
| Release Notes | ☐ Complete | ||
| Instructions for Use | ☐ Complete |
5.2 Release Documentation
| Document | Version | Status | Location |
|---|---|---|---|
| Release Notes | ☐ Complete | ||
| Installation Guide | ☐ Complete | ||
| User Manual / IFU | ☐ Complete | ||
| Known Issues List | ☐ Complete | ||
| Upgrade Guide | ☐ Complete |
6. Release Integrity and Security
6.1 Release Integrity Verification
Integrity Checks Performed:
- ☐ Checksums generated for all release artifacts
- ☐ Digital signatures applied
- ☐ Release artifacts scanned for malware
- ☐ Release package integrity verified
Checksum Algorithm Used: [e.g., SHA-256]
6.2 Release Security
Security Scan Results:
- ☐ No critical vulnerabilities detected
- ☐ No high severity vulnerabilities detected
- ☐ Known vulnerabilities documented and assessed
Security Scan Date: [Date]
Security Scan Tool: [Tool name and version]
7. Delivery and Distribution
7.1 Release Distribution Method
☐ Electronic Download
☐ Cloud Deployment
☐ Physical Media
☐ Other: [Specify]
7.2 Release Control Procedures
Procedures to ensure delivery without corruption or unauthorized change:
- [Procedure step 1]
- [Procedure step 2]
- [Procedure step 3]
Access Control:
- Release artifacts stored in: [Location]
- Access restricted to: [Roles/Individuals]
- Release approval required from: [Name/Role]
7.3 Release Tracking
Release Identifier: [Unique identifier for this release]
Release Log Entry: [Reference to release tracking system]
8. Deployment Instructions
8.1 Deployment Environment Requirements
| Component | Minimum Requirement | Recommended |
|---|---|---|
| Operating System | ||
| CPU | ||
| Memory | ||
| Disk Space | ||
| Network | ||
| Database |
8.2 Deployment Procedure
Pre-Deployment Steps:
- [Step 1]
- [Step 2]
Deployment Steps:
- [Step 1]
- [Step 2]
Post-Deployment Verification:
- [Step 1]
- [Step 2]
Rollback Procedure (if needed):
- [Step 1]
- [Step 2]
9. Release Archive
9.1 Archived Materials
| Material | Archive Location | Archive Date | Responsible |
|---|---|---|---|
| Source Code | |||
| Build Scripts | |||
| Configuration Files | |||
| Test Artifacts | |||
| Documentation | |||
| Release Package |
9.2 Archive Retention
Retention Period: [Specify retention period according to regulatory requirements]
Archive Access Control: [Describe access control measures]
9.3 Release Reproducibility
Reproducibility Verified: ☐ Yes ☐ No
Method: [Describe how release reproducibility is ensured]
10. Compliance and Approvals
10.1 Regulatory Compliance
This software release complies with:
- ☐ EN 62304:2006/A1:2015 - Medical device software lifecycle processes
- ☐ EN 82304-1:2016 - Health software product safety
- ☐ ISO 13485:2016 - Quality management systems for medical devices
- ☐ ISO 14971:2019 - Risk management for medical devices
- ☐ [Other applicable regulations]
10.2 Quality Management System Compliance
- ☐ All development activities performed according to GP-012
- ☐ All required documentation completed and reviewed
- ☐ All quality gates passed
- ☐ Configuration management procedures followed
- ☐ Change control procedures followed
10.3 Verification Checklist
| Verification Item | Status | Reference |
|---|---|---|
| Software verification completed | ☐ Complete | R-TF-012-035 |
| All software requirements verified | ☐ Complete | R-TF-012-043 |
| All tests passed or deviations documented | ☐ Complete | R-TF-012-035 |
| Residual anomalies evaluated | ☐ Complete | This document, Section 4 |
| Risk management activities completed | ☐ Complete | R-TF-013-002 |
| Documentation complete and approved | ☐ Complete | This document |
| Configuration items identified and controlled | ☐ Complete | This document, Section 3 |
| Release package integrity verified | ☐ Complete | This document, Section 6 |
11. Release Decision
11.1 Release Readiness
Based on the verification activities and results documented:
☐ Software is READY for RELEASE
All verification activities completed successfully. All acceptance criteria met.
☐ Software is READY for RELEASE with Observations
Minor issues documented and assessed as acceptable. Release approved with conditions.
☐ Software is NOT READY for RELEASE
Critical issues remain. Additional work required before release.
11.2 Release Conditions and Restrictions
[Document any conditions or restrictions on this release]
☐ No conditions or restrictions
11.3 Post-Release Activities
Planned post-release activities:
- Monitor for issues in production
- Collect user feedback
- Track and resolve defects
- Plan for next release
- Update documentation as needed
12. Approvals
| Role | Name | Signature | Date |
|---|---|---|---|
| Document Prepared By (JD-007) | |||
| Verification Approved (JD-003) | |||
| Release Approved (JD-001) |
13. Release Notes
13.1 Summary for Users
[Provide a user-friendly summary of this release, including key features, fixes, and any important information for users]
13.2 Installation and Upgrade Notes
[Provide important information about installation or upgrading from previous versions]
13.3 Known Issues
[List any known issues that users should be aware of]
13.4 Support Information
Technical Support Contact: [Contact information]
Feedback and Issue Reporting: [How to report issues]
Appendices
Appendix A: Release Manifest
[Detailed list of all files included in the release package]
Appendix B: Change Log
[Detailed change log since previous version]
Appendix C: Test Execution Summary
[Reference or summary of test execution results]
Appendix D: Configuration Management Records
[Reference to configuration management records for this release]
End of Verified Version Release