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      • Templates
        • T-029-001 Software Commissioning Plan
        • T-029-002 Software Commissioning Report
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  • GP-029 Software Delivery and Commissioning
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  • T-029-002 Software Commissioning Report

T-029-002 Software Commissioning Report

Document Information​

FieldValue
API/Product Name
Version
Release Date
Commissioning PeriodFrom: ___ To: ___
Report Prepared By
Report Prepared Date
Report Reviewed By
Report Review Date
Report Approved By
Report Approval Date
Related Commissioning PlanT-029-001 Version: ___
Related GP-012 Phase 5Document: ___

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]

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:

  • Pillar 1: Internal validation of the API in representative environments
  • Pillar 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​

ReferenceTitleVersion
T-029-001Software Commissioning Plan
GP-029Software Delivery and Commissioning
GP-012Design, Redesign and Development - Phase 5
IEC 82304-1:2016Health software - Product safetySection 6.2

2. Deployment Summary​

2.1 Deployment Activities​

ActivityPlanned DateActual DateStatusNotes
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​

ComponentSpecificationStatusVerification MethodNotes
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 IDDescriptionSeverityResolutionStatus
H/M/LOpen/Resolved

☐ No deployment issues encountered

3. Pillar 1: Internal Validation Results​

3.1 Representative Environments Created​

Environment TypeDescriptionInfrastructureStatusNotes
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 ApplicationPlatformPurposeStatusEvidence 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

PlatformTestsPassFailStatus
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

MetricTargetAchievedStatus
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

WorkflowTestsPassFailStatus
☐ Pass ☐ Fail
☐ Pass ☐ Fail
Key Findings

3.3.11 Integration Documentation Validation​

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

Document TestedResultIssues FoundActions 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 Pillar 1 Validation Summary​

Overall Validation Status: ☐ Pass ☐ Fail

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

3.5 Pillar 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 Pillar 1 Issues and Resolutions​

Issue IDSeverityDescriptionResolutionStatusVerification
H/M/LOpen/Resolved

☐ No critical issues identified

4. Pillar 2: Client Integration Assurance Process​

4.1 Client-Facing Documentation Status​

DocumentVersionPublication DateLocation/URLStatus
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​

ComponentDescriptionStatusVerification
Sandbox EnvironmentURL: **_**☐ Operational ☐ Issues
Test Credentials System☐ Operational ☐ Issues
Sample Data Sets☐ Available ☐ Pending
Support Email/PortalContact: **_**☐ 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​

MetricTargetStatus
Support Response Time☐ Defined ☐ To be defined
Issue Resolution Time☐ Defined ☐ To be defined
Documentation Update Frequency☐ Defined ☐ To be defined

4.5 Pillar 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)​

ClientIntegration StartStatusSupport SummaryOutcome
☐ In Progress ☐ Complete
☐ In Progress ☐ Complete

☐ No client integrations initiated during commissioning period

5. Post-Deployment Monitoring Results​

5.1 Initial Monitoring Period (24-48 hours)​

Monitoring Period: From: ___ To: ___

MetricTargetActualStatus
API Uptime99.9%☐ Met ☐ Not Met
Average Response Time☐ Met ☐ Not Met
Error Rate☐ Met ☐ Not Met
Total API CallsN/A

5.2 Monitoring Alerts​

Alert TypeThresholdTriggered?Action Taken
☐ Yes ☐ No
☐ Yes ☐ No

☐ No alerts triggered during monitoring period

5.3 Incidents and Issues​

Incident IDDate/TimeSeverityDescriptionResolutionImpact
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]

6. Acceptance Criteria Verification​

6.1 Pillar 1 Acceptance Criteria​

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

6.2 Pillar 2 Acceptance Criteria​

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

6.3 General Acceptance Criteria​

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

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

7. Deviations and Non-Conformances​

Deviation IDDescriptionImpactJustificationApproval
H/M/L

☐ No deviations from commissioning plan

8. Risk Management​

8.1 Risks Identified During Commissioning​

Risk IDDescriptionImpactMitigationStatus
H/M/LOpen/Closed

☐ No new risks identified

8.2 Risk Mitigation Verification​

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

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]

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 (Pillar 1)
  2. Establishment of comprehensive client integration assurance process (Pillar 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: ****_****

11. Traceability to GP-012 Phase 5​

GP-012 Phase 5 Validation Requirements:

RequirementStatusEvidence in this Report
Product validation in intended environment☐ CompleteSection 3
Clinical evaluation completed (GP-015)☐ CompleteReference: **_**
Validation protocol executed☐ CompleteSection 3
Validation report completed☐ CompleteThis document
Phase 5 checklist completion☐ ReadyAll criteria met

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

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 ItemPriorityResponsibleTarget DateStatus
H/M/L

☐ No outstanding action items

13. Approvals​

RoleNameSignatureDate
Report Prepared By (JD-007)
Report Reviewed By (JD-003)
Commissioning Approved By (JD-001)

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

End of Software Commissioning Report

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T-029-001 Software Commissioning Plan
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GP-030 Cyber Security Management
  • Document Information
  • Executive Summary
    • Commissioning Outcome
    • Key Findings
    • Recommendations
  • 1. Introduction
    • 1.1 Purpose
    • 1.2 Scope
    • 1.3 References
  • 2. Deployment Summary
    • 2.1 Deployment Activities
    • 2.2 Production Environment Status
    • 2.3 Deployment Issues
  • 3. Pillar 1: Internal Validation Results
    • 3.1 Representative Environments Created
    • 3.2 Test Applications Developed
    • 3.3 Validation Test Results Summary
      • 3.3.1 Endpoint Availability Testing
      • 3.3.2 Authentication and Authorization Testing
      • 3.3.3 Mobile App Integration Testing
      • 3.3.4 Web Application Integration Testing
      • 3.3.5 EHR Integration Testing
      • 3.3.6 Error Handling and Logging
      • 3.3.7 Performance Testing
      • 3.3.8 Security Validation
      • 3.3.9 Data Integrity Validation
      • 3.3.10 End-to-End Clinical Workflow Testing
      • 3.3.11 Integration Documentation Validation
    • 3.4 Pillar 1 Validation Summary
    • 3.5 Pillar 1 Conclusions
    • 3.6 Pillar 1 Issues and Resolutions
  • 4. Pillar 2: Client Integration Assurance Process
    • 4.1 Client-Facing Documentation Status
    • 4.2 Client Support Infrastructure Status
    • 4.3 Client Onboarding Process
    • 4.4 Support Metrics and SLAs
    • 4.5 Pillar 2 Implementation Status
    • 4.6 Initial Client Integrations (if applicable)
  • 5. Post-Deployment Monitoring Results
    • 5.1 Initial Monitoring Period (24-48 hours)
    • 5.2 Monitoring Alerts
    • 5.3 Incidents and Issues
    • 5.4 Log Analysis Summary
  • 6. Acceptance Criteria Verification
    • 6.1 Pillar 1 Acceptance Criteria
    • 6.2 Pillar 2 Acceptance Criteria
    • 6.3 General Acceptance Criteria
  • 7. Deviations and Non-Conformances
  • 8. Risk Management
    • 8.1 Risks Identified During Commissioning
    • 8.2 Risk Mitigation Verification
  • 9. Lessons Learned
    • 9.1 What Went Well
    • 9.2 Areas for Improvement
    • 9.3 Recommendations for Future Commissioning
  • 10. Compliance Statement
  • 11. Traceability to GP-012 Phase 5
  • 12. Conclusions
    • 12.1 Commissioning Success
    • 12.2 Readiness for Market Release
    • 12.3 Key Achievements
    • 12.4 Outstanding Action Items
  • 13. Approvals
  • 14. Appendices
    • Appendix A: Detailed Test Results
    • Appendix B: Client Integration Records
    • Appendix C: Performance Data
    • Appendix D: Security Assessment
    • Appendix E: Representative Environment Documentation
    • Appendix F: Test Applications
    • Appendix G: Evidence Package
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI LABS GROUP S.L.)