R-T-029-001 Software Commissioning Plan

Document Information

Field	Value
API/Product Name
Version
Release Date
Plan Prepared By
Plan Prepared Date
Plan Approved By
Plan Approval Date
Related GP-012 Phase 5

1. Executive Summary

1.1 Purpose

This Software Commissioning Plan describes the approach for validating and commissioning the [API Name] Version [X.X] in its intended environment of use, in accordance with procedure GP-029 and IEC 82304-1:2016 section 6.2.

1.2 Scope

This plan covers:

• Objective 1: Internal validation of the API in representative environments that simulate client integrations
• Objective 2: Client integration assurance process to ensure clients can integrate the API correctly and safely
• Deployment of the API to production infrastructure
• Validation activities in representative test environments
• Preparation and delivery of client documentation and support resources
• Post-deployment monitoring and client support

1.3 Commissioning Objectives

• Deploy API to production infrastructure
• Validate API functionality in representative client integration environments
• Demonstrate that API can be successfully integrated by clients (Objective 1)
• Prepare complete client integration documentation and resources
• Establish client integration assurance process (Objective 2)
• Commission API for client use
• Establish post-deployment monitoring and support

2. API Release Package

2.1 Software Artifacts

Artifact	Version	Location	Status
API Compiled Artifacts
Configuration Templates
Database Migration Scripts
Deployment Scripts

2.2 Documentation

Document	Version	Location	Status
Release Notes
API Documentation (OpenAPI/Swagger)
Integration Guide
Instructions for Use (IFU)
Known Issues and Limitations

2.3 Client Resources

Resource	Version	Location	Status
Client SDK/Libraries
Code Examples
Sample Data Sets
Authentication Guide

3. Production Environment Preparation

3.1 Infrastructure Requirements

Component	Specification	Status	Notes
Cloud/Server Infrastructure
Network Configuration
Load Balancers
DNS Configuration
SSL/TLS Certificates
Database Systems
Authentication Services
Monitoring Infrastructure
Logging Infrastructure
Backup Systems

3.2 Client Support Infrastructure

Component	Specification	Status	Notes
Sandbox/Test Environment
API Documentation Portal
Support Ticketing System
Test Credentials System

4. Deployment Plan

4.1 Deployment Schedule

Activity	Planned Date	Responsible	Status
Pre-deployment verification
Database migration (if applicable)
API deployment to production
Configuration verification
Post-deployment verification
Go/No-Go decision

4.2 Rollback Plan

Rollback Trigger Conditions:

• Critical functionality failure
• Security vulnerability detected
• Data integrity issues
• Performance below acceptable thresholds
• Other (specify): **___**

Rollback Procedure:

1. [Step 1]
2. [Step 2]
3. [Step 3]

Rollback Responsible Party: **___**

5. Objective 1: Internal Validation in Representative Environments

5.1 Representative Test Environments

Environment Type	Description	Infrastructure	Status
Mobile App Integration (iOS)
Mobile App Integration (Android)
Web Application Integration
EHR System Integration
Telemedicine Platform
Other: **___**

5.2 Test Applications to be Developed

Test Application	Platform	Purpose	Development Status
Test Mobile App (iOS)
Test Mobile App (Android)
Test Web App
Test EHR Integration
Other: **__**

5.3 Integration Test Scenarios

Scenario ID	Scenario Description	Environment	Expected Outcome	Priority
ITS-001				High/Med/Low
ITS-002
ITS-003
ITS-004
ITS-005

5.4 Validation Test Cases

See Annex A: Objective 1 Validation Checklist for detailed test cases covering:

• Endpoint availability testing
• Authentication and authorization testing
• Integration scenario testing (mobile, web, EHR, etc.)
• Error handling validation
• Performance testing
• Security validation
• Data integrity validation
• End-to-end clinical workflow testing
• Integration documentation validation

6. Objective 2: Client Integration Assurance Process

6.1 Client-Facing Documentation Preparation

Document	Responsible	Target Date	Status
API Integration Guide
API Reference Documentation
Instructions for Use (IFU)
Authentication & Authorization Guide
Error Handling Guide
Code Examples (specify languages)
Client Support Procedures
Integration Best Practices
API Changelog

6.2 Client Support Infrastructure

Infrastructure Component	Description	Responsible	Status
Sandbox Environment URL
Test Credentials System
Sample Data Sets
Support Email/Portal
Support Response Time SLA

6.3 Client Integration Process

See Annex B: Client Integration Checklist for detailed process covering:

• Pre-integration phase (documentation, sandbox access, onboarding)
• During integration phase (technical support, monitoring)
• Pre-production validation (client testing checklist, integration review)
• Post-integration support (monitoring, validation, ongoing support)

7. Acceptance Criteria

7.1 Objective 1 Acceptance Criteria

• All representative test environments created and documented
• All test applications developed and functional
• All integration test scenarios executed successfully
• All validation test cases passed (see Annex A)
• Integration documentation validated through actual testing
• Validation report completed (T-029-002)
• Objective evidence that API can be successfully integrated by clients

7.2 Objective 2 Acceptance Criteria

• All client-facing documentation completed and published
• API Integration Guide validated through internal testing
• Sandbox environment operational and accessible
• Test credentials and sample data available
• Support infrastructure operational
• Support team trained and ready
• Client onboarding process defined

7.3 General Acceptance Criteria

• API deployed successfully to production
• All production infrastructure components operational
• Performance meets specifications
• Security controls validated
• Monitoring and alerting operational
• Backup and recovery procedures validated
• Commissioning checklist completed (Annex A & B)

8. Roles and Responsibilities

Role	Name	Responsibilities
JD-001		Approve commissioning and deployment
JD-003		Oversee validation and commissioning activities
JD-007		Execute deployment, validation, and prepare client resources
JD-004		Ensure documentation is generated and archived

9. Risk Management

9.1 Identified Risks

Risk ID	Risk Description	Probability	Impact	Mitigation Strategy	Owner
R-001		H/M/L	H/M/L
R-002
R-003

9.2 Contingency Plans

[Describe contingency plans for major risks]

10. Communication Plan

10.1 Internal Communication

Stakeholder	Information	Frequency	Method

10.2 Client Communication

Milestone	Communication Type	Content	Timing
API Go-Live
Documentation Available
Support Channels Open

11. Schedule and Milestones

Milestone	Description	Target Date	Status
M1	API deployment to production completed
M2	Representative test environments ready
M3	Objective 1 validation completed
M4	Client documentation completed
M5	Sandbox environment operational
M6	API go-live for clients
M7	Commissioning completed

12. Success Metrics

Metric	Target	Measurement Method
API Uptime	99.9%	Monitoring dashboard
Response Time (p95)	< X ms	Performance monitoring
Error Rate	< X%	Logging analysis
Successful Integrations	X clients in Y days	Integration records
Support Response Time	< X hours	Support ticket system
Documentation Satisfaction	> X/10	Client feedback

13. Post-Commissioning Activities

13.1 Initial Monitoring Period (24-48 hours)

• Continuous API performance monitoring
• Log review for errors or anomalies
• Monitoring alert validation
• Initial client integration support

13.2 Post-Deployment Review (within 1 week)

• Review deployment issues and resolutions
• Assess actual vs expected performance
• Review client feedback
• Document lessons learned
• Identify improvements

13.3 Ongoing Activities

• Continuous API monitoring
• Client integration support
• Documentation updates based on feedback
• Integration records maintenance (T-029-002)

Approvals

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

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Annex A: Objective 1 Validation Checklist

A.1 Endpoint Availability Testing

Test ID	Test Description	Expected Result	Actual Result	Pass/Fail	Notes
EP-001	Verify API endpoints publicly accessible
EP-002	Verify DNS resolution works correctly
EP-003	Verify load balancing distributes requests
EP-004	Verify health check endpoints respond
EP-005	Verify API versioning and routing

A.2 Authentication and Authorization Testing

Test ID	Test Description	Expected Result	Actual Result	Pass/Fail	Notes
AU-001	Test HTTP(S) calls with API keys
AU-002	Test OAuth authentication flow
AU-003	Test JWT token authentication
AU-004	Test authorization rules enforcement
AU-005	Test rate limiting application
AU-006	Test token expiration and refresh
AU-007	Test invalid/expired credentials handling

A.3 Mobile App Integration Testing

Test ID	Test Description	Expected Result	Actual Result	Pass/Fail	Notes
MOB-001	Test mobile app can call all API endpoints
MOB-002	Test authentication flow from mobile
MOB-003	Test data exchange formats with mobile
MOB-004	Test with various network conditions
MOB-005	Test offline/online transitions (if applicable)
MOB-006	Test iOS platform compatibility
MOB-007	Test Android platform compatibility

A.4 Web Application Integration Testing

Test ID	Test Description	Expected Result	Actual Result	Pass/Fail	Notes
WEB-001	Test web app can call all API endpoints
WEB-002	Test authentication flow from web app
WEB-003	Test CORS configuration (if applicable)
WEB-004	Test with different browsers
WEB-005	Test with various network conditions

A.5 EHR Integration Testing

Test ID	Test Description	Expected Result	Actual Result	Pass/Fail	Notes
EHR-001	Test EHR data format compatibility (HL7/FHIR)
EHR-002	Test clinical data workflow
EHR-003	Test data mapping and transformation
EHR-004	Test bidirectional data exchange

A.6 Error Handling and Logging

Test ID	Test Description	Expected Result	Actual Result	Pass/Fail	Notes
ERR-001	Verify error responses follow specifications
ERR-002	Verify error messages don't expose sensitive data
ERR-003	Verify client can handle all error scenarios
ERR-004	Verify logging captures troubleshooting info
ERR-005	Verify monitoring receives metrics correctly
ERR-006	Verify alerting mechanisms function

A.7 Performance Testing

Test ID	Test Description	Expected Result	Actual Result	Pass/Fail	Notes
PERF-001	Measure response latency under normal load
PERF-002	Verify availability target maintained
PERF-003	Measure throughput under load
PERF-004	Test under peak load conditions
PERF-005	Verify resource utilization acceptable
PERF-006	Test graceful degradation under stress

A.8 Security Validation

Test ID	Test Description	Expected Result	Actual Result	Pass/Fail	Notes
SEC-001	Verify data encryption in transit (TLS/SSL)
SEC-002	Verify data encryption at rest
SEC-003	Verify input validation and sanitization
SEC-004	Verify HTTPS enforcement
SEC-005	Verify security headers configured
SEC-006	Review vulnerability scanning results
SEC-007	Verify security logging operational

A.9 Data Integrity Validation

Test ID	Test Description	Expected Result	Actual Result	Pass/Fail	Notes
DATA-001	Verify data validation rules applied
DATA-002	Verify data persistence operates correctly
DATA-003	Verify backup mechanisms function
DATA-004	Verify data recovery procedures
DATA-005	Verify audit trails capture information

A.10 End-to-End Clinical Workflow Testing

Test ID	Test Description	Expected Result	Actual Result	Pass/Fail	Notes
CLIN-001	Execute clinical workflow 1
CLIN-002	Execute clinical workflow 2
CLIN-003	Validate clinical algorithms accuracy
CLIN-004	Test with edge cases and boundary conditions

A.11 Integration Documentation Validation

Test ID	Test Description	Expected Result	Actual Result	Pass/Fail	Notes
DOC-001	Follow integration guide step-by-step
DOC-002	Test all code examples provided
DOC-003	Verify API reference documentation accuracy
DOC-004	Verify authentication guide clarity
DOC-005	Verify error handling documentation completeness

Summary:

• Total Test Cases: _
• Passed: _
• Failed: _
• Blocked: _
• Validation Date: _
• Validated By: _

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Annex B: Client Integration Checklist

B.1 Pre-Integration Phase

Activity	Description	Responsible	Status	Notes
Documentation Published	All client-facing documentation available
Sandbox Environment Ready	Test environment accessible to clients
Test Credentials Available	Test credentials generated and delivery method ready
Sample Data Prepared	Sample datasets available for testing
Support Channels Established	Email/portal/ticketing system operational
Support Team Trained	Support team ready to assist clients

B.2 Client Onboarding Process

Step	Activity	Client Deliverable	AI Labs Deliverable
1	Initial contact with client
2	Overview of integration process
3	Identify client use case
4	Provide sandbox access
5	Deliver test credentials
6	Share integration guide
7	Schedule check-in meetings

B.3 During Integration Support

Support Activity	Description	SLA	Status
Technical support channel	Email/portal for questions
Integration monitoring	Monitor sandbox API usage
Proactive outreach	Contact clients if issues detected
Best practices communication	Share optimal usage patterns
Documentation updates	Update docs based on feedback

B.4 Client Pre-Production Testing Checklist

Recommended checklist to provide to clients before production go-live:

• Functional testing of all integrated API endpoints completed
• Authentication and authorization tested
• Error handling tested with various scenarios
• Performance testing under expected load completed
• Security testing completed (encryption, credential storage)
• End-to-end testing in client's staging environment completed
• User acceptance testing with end users completed
• Production credentials requested and received
• Production cutover plan prepared
• Rollback plan prepared

B.5 Production Go-Live Support

Activity	Description	Timing	Responsible
Production credentials delivery	Securely deliver production API keys
Go-live readiness review	Confirm client readiness
Enhanced monitoring	Monitor client production usage closely	First 48-72h
On-call support availability	Be available for urgent support
Issue escalation process	Fast-track critical issues

B.6 Post-Integration Validation

Activity	Description	Timing	Status
Performance review	Review client API usage metrics	1-2 weeks post go-live
Client feedback collection	Gather integration experience feedback
Issue documentation	Document any issues and resolutions
Integration success confirmation	Confirm stable integration

B.7 Client Integration Records

For each client integration, maintain record (T-029-002) including:

• Client name and contact information
• Integration start date
• Production go-live date
• Support requests log and resolutions
• Integration issues identified
• Client feedback received
• Status: ☐ In Progress ☐ Completed ☐ On Hold

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End of Software Commissioning Plan