T-012-038 Verified Version Release

Actors

Name	Title	Meaning	Approved Date & Time

Change history

Revision	Summary	Date

Project information

• Project title:
• Version number:
• Release branch: release/W.X.Y.Z

Pre-requisites verification

Before completing this document, verify that all required Phase 4 activities have been completed:

Pre-requisite	Reference Document	Completed
T-012-024 Software Candidate Release Phase 3 Checklist approved	T-012-024
Release Candidate built from release branch
T-012-033 Software Test Plan available	T-012-033
T-012-034 Software Test Description available	T-012-034
T-012-035 Software Test Report completed	T-012-035
All test cases executed per test plan
Residual anomalies identified and risk-assessed

Release Metadata

Field	Value
Version number
Version tag
Release branch
Build date
Release Candidate identifier

Verifications

Instructions

Summarize the conclusions of the review process based on the Quality Management System. Verify that:

• All test cases have been executed and results documented
• Quality controls were completed and satisfactory
• The software is safe to use based on residual anomaly risk assessment
• The software complies with IEC 62304 requirements
• The software meets its intended use and quality standards

Write each point as a clear, affirmative verification.

Verification item	Status	Comments
All unit tests passed
All integration tests passed
All system tests passed
All residual anomalies have acceptable risk assessments
Software verification is complete per IEC 62304 clause 5.5-5.7
Software is ready for validation activities in Phase 5

Technical Specifications

Instructions

Describe the scope of the release in terms of functional requirements:

• Number of software requirements verified in this version
• Reference to R-TF-012-028 Software Requirement Specification
• Reference to R-TF-012-043 Traceability Matrix for requirement coverage
• Summary of key features/capabilities in this version

Specification	Value/Reference
Total software requirements
Requirements verified
Software Requirement Specification	R-TF-012-028
Traceability Matrix	R-TF-012-043

Test Execution Summary

Test category	Total tests	Passed	Failed	Blocked	Pass rate
Unit tests
Integration tests
System tests
Regression tests
Total

Known Residual Anomalies

Instructions

List all known residual anomalies detected during verification. For each anomaly:

• Provide a unique identifier (e.g., bug tracker ID)
• Describe the anomaly briefly
• Document the risk assessment (severity, probability, risk level)
• Justify why the anomaly is acceptable for release
• Describe any mitigation measures

If no residual anomalies exist, state "No residual anomalies identified."

ID	Summary	Severity	Probability	Risk Level	Justification/Mitigation	Acceptable

Version Release Authorization

Instructions

The JD-007 (Technical Manager) formally releases this verified version for Phase 5 validation activities.

Release statement

This version has been verified according to GP-012 Software Design and Development procedure and IEC 62304 requirements. All verification activities are complete and documented. Known residual anomalies have been assessed and are acceptable. This version is authorized to proceed to Phase 5 Product Validation.

Approval

Role	Name	Signature	Date
JD-007 (Technical Manager)
JD-003 (Quality Manager)

References

• T-012-025 Software Verification Phase 4 Checklist
• T-012-033 Software Test Plan
• T-012-034 Software Test Description
• T-012-035 Software Test Report
• R-TF-012-028 Software Requirement Specification
• R-TF-012-043 Traceability Matrix
• R-TF-013-002 Risk Management Record (for residual anomaly risk assessment)