R-T-029-002 Software Commissioning Report

Document Information

Field	Value
API/Product Name
Version
Release Date
Commissioning Period	From: ___ To: ___
Report Prepared By
Report Prepared Date
Report Reviewed By
Report Review Date
Report Approved By
Report Approval Date
Related Commissioning Plan	T-029-001 Version: ___
Related GP-012 Phase 5	Document: ___

Executive Summary

Commissioning Outcome

☐ Successful - API commissioned and operating as intended
☐ Successful with observations - API commissioned with minor issues documented
☐ Unsuccessful - API not commissioned, critical issues identified

Key Findings

[Provide a brief summary of the commissioning outcomes, key findings, and any significant issues]

Recommendations

[Provide key recommendations based on commissioning activities]

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1. Introduction

1.1 Purpose

This Software Commissioning Report documents the results of commissioning activities for [API Name] Version [X.X] as described in the Software Commissioning Plan (T-029-001). This report provides evidence that the API has been validated in its intended environment of use and is ready for client integration, in accordance with IEC 82304-1:2016 section 6.2 and procedure GP-029.

1.2 Scope

This report documents the results of:

• Objective 1: Internal validation of the API in representative environments
• Objective 2: Client integration assurance process establishment
• API deployment to production infrastructure
• Validation activities and test results
• Client documentation preparation and delivery
• Initial post-deployment monitoring

1.3 References

Reference	Title	Version
T-029-001	Software Commissioning Plan
GP-029	Software Delivery and Commissioning
GP-012	Design, Redesign and Development - Phase 5
IEC 82304-1:2016	Health software - Product safety	Section 6.2

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2. Deployment Summary

2.1 Deployment Activities

Activity	Planned Date	Actual Date	Status	Notes
Pre-deployment verification			☐ Complete ☐ Incomplete
Database migration			☐ Complete ☐ Incomplete ☐ N/A
API deployment to production			☐ Complete ☐ Incomplete
Configuration verification			☐ Complete ☐ Incomplete
Post-deployment verification			☐ Complete ☐ Incomplete

2.2 Production Environment Status

Component	Specification	Status	Verification Method	Notes
API Endpoints		☐ Operational ☐ Issues
Authentication Services		☐ Operational ☐ Issues
Database Systems		☐ Operational ☐ Issues
Load Balancers		☐ Operational ☐ Issues
Monitoring Systems		☐ Operational ☐ Issues
Logging Systems		☐ Operational ☐ Issues
Backup Systems		☐ Operational ☐ Issues
Sandbox Environment		☐ Operational ☐ Issues

2.3 Deployment Issues

Issue ID	Description	Severity	Resolution	Status
		H/M/L		Open/Resolved

☐ No deployment issues encountered

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3. Objective 1: Internal Validation Results

3.1 Representative Environments Created

Environment Type	Description	Infrastructure	Status	Notes
Mobile App (iOS)			☐ Complete ☐ Partial
Mobile App (Android)			☐ Complete ☐ Partial
Web Application			☐ Complete ☐ Partial
EHR System			☐ Complete ☐ Partial ☐ N/A
Telemedicine Platform			☐ Complete ☐ Partial ☐ N/A
Other: **_**			☐ Complete ☐ Partial

3.2 Test Applications Developed

Test Application	Platform	Purpose	Status	Evidence Location
			☐ Complete ☐ Partial
			☐ Complete ☐ Partial

3.3 Validation Test Results Summary

3.3.1 Endpoint Availability Testing

Total Tests: _ Passed: _ Failed: _ Status: ☐ Pass ☐ Fail

Key Findings

3.3.2 Authentication and Authorization Testing

Total Tests: _ Passed: _ Failed: _ Status: ☐ Pass ☐ Fail

Key Findings

3.3.3 Mobile App Integration Testing

Total Tests: _ Passed: _ Failed: _ Status: ☐ Pass ☐ Fail

Platform	Tests	Pass	Fail	Status
iOS				☐ Pass ☐ Fail ☐ N/A
Android				☐ Pass ☐ Fail ☐ N/A

Key Findings

3.3.4 Web Application Integration Testing

Total Tests: _ Passed: _ Failed: _ Status: ☐ Pass ☐ Fail

Key Findings

3.3.5 EHR Integration Testing

Total Tests: _ Passed: _ Failed: _ Status: ☐ Pass ☐ Fail ☐ N/A

Key Findings

3.3.6 Error Handling and Logging

Total Tests: _ Passed: _ Failed: _ Status: ☐ Pass ☐ Fail

Key Findings

3.3.7 Performance Testing

Total Tests: _ Passed: _ Failed: _ Status: ☐ Pass ☐ Fail

Metric	Target	Achieved	Status
Response Time (p95)			☐ Pass ☐ Fail
Throughput			☐ Pass ☐ Fail
Availability			☐ Pass ☐ Fail
Concurrent Users			☐ Pass ☐ Fail

Key Findings

3.3.8 Security Validation

Total Tests: _ Passed: _ Failed: _ Status: ☐ Pass ☐ Fail

Key Findings

3.3.9 Data Integrity Validation

Total Tests: _ Passed: _ Failed: _ Status: ☐ Pass ☐ Fail

Key Findings

3.3.10 End-to-End Clinical Workflow Testing

Total Tests: _ Passed: _ Failed: _ Status: ☐ Pass ☐ Fail

Workflow	Tests	Pass	Fail	Status
				☐ Pass ☐ Fail
				☐ Pass ☐ Fail

Key Findings

3.3.11 Integration Documentation Validation

Total Tests: _ Passed: _ Failed: _ Status: ☐ Pass ☐ Fail

Document Tested	Result	Issues Found	Actions Taken
API Integration Guide	☐ Pass ☐ Fail
API Reference Documentation	☐ Pass ☐ Fail
Code Examples	☐ Pass ☐ Fail
Authentication Guide	☐ Pass ☐ Fail
Error Handling Guide	☐ Pass ☐ Fail

Key Findings

3.4 Objective 1 Validation Summary

Overall Validation Status: ☐ Pass ☐ Fail

Total Test Cases Executed: _
Passed: _
Failed: _
Pass Rate: _%

3.5 Objective 1 Conclusions

Objective Evidence of Successful Integration Capability:

[Provide statement confirming that internal validation demonstrates the API can be successfully integrated by clients]

☐ Confirmed: Internal validation in representative environments demonstrates that the API satisfies user requirements and can be successfully integrated into client applications (mobile, web, EHR, etc.)

☐ Not Confirmed: Critical issues prevent confirmation. See issues log.

3.6 Objective 1 Issues and Resolutions

Issue ID	Severity	Description	Resolution	Status	Verification
	H/M/L			Open/Resolved

☐ No critical issues identified

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4. Objective 2: Client Integration Assurance Process

4.1 Client-Facing Documentation Status

Document	Version	Publication Date	Location/URL	Status
API Integration Guide				☐ Published ☐ Pending
API Reference Documentation				☐ Published ☐ Pending
Instructions for Use (IFU)				☐ Published ☐ Pending
Authentication Guide				☐ Published ☐ Pending
Error Handling Guide				☐ Published ☐ Pending
Code Examples				☐ Published ☐ Pending
Client Support Procedures				☐ Published ☐ Pending
Integration Best Practices				☐ Published ☐ Pending
API Changelog				☐ Published ☐ Pending

4.2 Client Support Infrastructure Status

Component	Description	Status	Verification
Sandbox Environment	URL: **_**	☐ Operational ☐ Issues
Test Credentials System		☐ Operational ☐ Issues
Sample Data Sets		☐ Available ☐ Pending
Support Email/Portal	Contact: **_**	☐ Operational ☐ Issues
Support Team Readiness		☐ Ready ☐ Training Needed

4.3 Client Onboarding Process

Process Status: ☐ Established ☐ In Development

Key Elements:

• ☐ Onboarding documentation prepared
• ☐ Initial contact process defined
• ☐ Sandbox access procedure established
• ☐ Test credentials delivery method defined
• ☐ Support escalation process defined
• ☐ Client check-in schedule template created

4.4 Support Metrics and SLAs

Metric	Target	Status
Support Response Time		☐ Defined ☐ To be defined
Issue Resolution Time		☐ Defined ☐ To be defined
Documentation Update Frequency		☐ Defined ☐ To be defined

4.5 Objective 2 Implementation Status

Overall Status: ☐ Complete and Operational ☐ Partial ☐ In Progress

Readiness for Client Integrations:

☐ Ready: All client-facing documentation published, sandbox operational, support infrastructure ready

☐ Not Ready: Outstanding items prevent client integrations. See action items below.

4.6 Initial Client Integrations (if applicable)

Client	Integration Start	Status	Support Summary	Outcome
		☐ In Progress ☐ Complete
		☐ In Progress ☐ Complete

☐ No client integrations initiated during commissioning period

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5. Post-Deployment Monitoring Results

5.1 Initial Monitoring Period (24-48 hours)

Monitoring Period: From: ___ To: ___

Metric	Target	Actual	Status
API Uptime	99.9%		☐ Met ☐ Not Met
Average Response Time			☐ Met ☐ Not Met
Error Rate			☐ Met ☐ Not Met
Total API Calls			N/A

5.2 Monitoring Alerts

Alert Type	Threshold	Triggered?	Action Taken
		☐ Yes ☐ No
		☐ Yes ☐ No

☐ No alerts triggered during monitoring period

5.3 Incidents and Issues

Incident ID	Date/Time	Severity	Description	Resolution	Impact
		H/M/L

☐ No incidents during monitoring period

5.4 Log Analysis Summary

Logs Reviewed: ☐ Yes ☐ No

Key Findings:

[Summarize any notable findings from log analysis]

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6. Acceptance Criteria Verification

6.1 Objective 1 Acceptance Criteria

Criterion	Status	Evidence
All representative test environments created and documented	☐ Met ☐ Not Met	Section 3.1
All test applications developed and functional	☐ Met ☐ Not Met	Section 3.2
All integration test scenarios executed successfully	☐ Met ☐ Not Met	Section 3.3
All validation test cases passed	☐ Met ☐ Not Met	Section 3.3, Annex A
Integration documentation validated	☐ Met ☐ Not Met	Section 3.3.11
Validation provides objective evidence API can be integrated	☐ Met ☐ Not Met	Section 3.5

6.2 Objective 2 Acceptance Criteria

Criterion	Status	Evidence
All client-facing documentation completed and published	☐ Met ☐ Not Met	Section 4.1
API Integration Guide validated through testing	☐ Met ☐ Not Met	Section 3.3.11
Sandbox environment operational	☐ Met ☐ Not Met	Section 4.2
Test credentials and sample data available	☐ Met ☐ Not Met	Section 4.2
Support infrastructure operational	☐ Met ☐ Not Met	Section 4.2
Support team trained and ready	☐ Met ☐ Not Met	Section 4.2
Client onboarding process defined	☐ Met ☐ Not Met	Section 4.3

6.3 General Acceptance Criteria

Criterion	Status	Evidence
API deployed successfully to production	☐ Met ☐ Not Met	Section 2
All production infrastructure operational	☐ Met ☐ Not Met	Section 2.2
Performance meets specifications	☐ Met ☐ Not Met	Section 3.3.7, 5.1
Security controls validated	☐ Met ☐ Not Met	Section 3.3.8
Monitoring and alerting operational	☐ Met ☐ Not Met	Section 2.2, 5.2
Backup procedures validated	☐ Met ☐ Not Met	Section 2.2

Overall Acceptance: ☐ All criteria met ☐ Criteria not met (see deviations)

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7. Deviations and Non-Conformances

Deviation ID	Description	Impact	Justification	Approval
		H/M/L

☐ No deviations from commissioning plan

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8. Risk Management

8.1 Risks Identified During Commissioning

Risk ID	Description	Impact	Mitigation	Status
		H/M/L		Open/Closed

☐ No new risks identified

8.2 Risk Mitigation Verification

[Verify that planned risk mitigations from commissioning plan were effective]

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9. Lessons Learned

9.1 What Went Well

[Document positive aspects of the commissioning process]

9.2 Areas for Improvement

[Document areas where the commissioning process could be improved]

9.3 Recommendations for Future Commissioning

[Provide specific recommendations for future API releases]

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10. Compliance Statement

This Software Commissioning Report provides evidence that [API Name] Version [X.X] has been:

• ☐ Deployed to production infrastructure in a controlled manner
• ☐ Validated in representative environments that simulate intended use (IEC 82304-1:2016, section 6.2)
• ☐ Demonstrated to satisfy user requirements when integrated into client applications
• ☐ Prepared with complete client-facing documentation and integration resources
• ☐ Equipped with client integration assurance processes
• ☐ Commissioned for operational use and client integration

IEC 82304-1:2016 Section 6.2 Compliance:

The manufacturer has demonstrated that the software product satisfies user requirements in the intended environment of use through:

1. Internal validation in representative environments simulating mobile, web, and EHR integrations (Objective 1)
2. Establishment of comprehensive client integration assurance process (Objective 2)
3. Provision of complete integration documentation validated through actual testing
4. Objective evidence that the API can be successfully integrated by clients

☐ Compliance Confirmed

☐ Compliance Not Confirmed - Outstanding issues: ****_****

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11. Traceability to GP-012 Phase 5

GP-012 Phase 5 Validation Requirements:

Requirement	Status	Evidence in this Report
Product validation in intended environment	☐ Complete	Section 3
Clinical evaluation completed (GP-015)	☐ Complete	Reference: **_**
Validation protocol executed	☐ Complete	Section 3
Validation report completed	☐ Complete	This document
Phase 5 checklist completion	☐ Ready	All criteria met

Phase 5 Completion Status: ☐ Ready for completion ☐ Outstanding items

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12. Conclusions

12.1 Commissioning Success

[Provide overall conclusion on commissioning success]

12.2 Readiness for Market Release

Based on the commissioning activities documented in this report:

☐ Ready for Market Release: The API has been successfully commissioned, validated in representative environments, and is ready for client integration and market release.

☐ Conditional Release: Minor issues require resolution before full market release. See action items.

☐ Not Ready: Critical issues prevent market release. See issues log and action items.

12.3 Key Achievements

[Summarize key achievements of the commissioning process]

12.4 Outstanding Action Items

Action Item	Priority	Responsible	Target Date	Status
	H/M/L

☐ No outstanding action items

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13. Approvals

Role	Name	Signature	Date
Report Prepared By (JD-007)
Report Reviewed By (JD-003)
Commissioning Approved By (JD-001)

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14. Appendices

Appendix A: Detailed Test Results

[Attach or reference detailed test results from Annex A of T-029-001]

Appendix B: Client Integration Records

[Attach or reference any client integration records from commissioning period]

Appendix C: Performance Data

[Attach detailed performance monitoring data, graphs, metrics]

Appendix D: Security Assessment

[Attach security validation evidence, vulnerability scan results]

Appendix E: Representative Environment Documentation

[Attach detailed documentation of representative test environments created]

Appendix F: Test Applications

[Reference or describe test applications developed for validation]

Appendix G: Evidence Package

[List all evidence collected during commissioning]

Evidence Item	Type	Location/Reference
Test execution logs
Performance monitoring data
Security scan results
Screenshots of test applications
API call logs
Client feedback (if applicable)

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End of Software Commissioning Report