R-TF-029-003 — Clinical Workflow and Operational Readiness Commissioning Record
Document Control
- Record ID: R-TF-029-003
- Template Reference: T-029-003 — Clinical Workflow & Operational Readiness Commissioning
- Device: Legit.Health Plus
- Record Type: Commissioning Record
- Lifecycle Phase: Release / Commissioning
- Standard(s): ISO 62304, ISO 82304-1
Release and Identification
Regulatory objective: Establish traceability between clinical workflow commissioning results and the commissioned software baseline.
| Item | Value |
|---|---|
| Device name | Legit.Health Plus |
| Software version | 1.1.0.0 |
| Internal release identifier | 1.1.0.0 |
| Commissioning execution date | |
| Clinical workflows commissioned | Diagnosis support; Severity assessment |
Intended Clinical Workflow Confirmation
Regulatory objective: Confirm that commissioned workflows correspond to the approved intended use (ISO 82304-1 §7.2).
- Diagnosis support corresponds to the approved intended use of the device.
- Severity assessment corresponds to the approved intended use of the device.
End-to-End Clinical Workflow Execution
Regulatory objective: Confirm that complete clinical workflows execute successfully in the production environment.
The following clinical workflows were executed using valid commissioning inputs and completed successfully:
- Diagnosis support of clinical images
- Severity assessment workflow executed via a single API endpoint, parameterized to compute different clinical signs depending on the requested clinical score
The severity assessment workflow was exercised using parameter combinations corresponding to the following clinical scores:
- PASI (e.g. erythema, desquamation, crusting)
- SCORAD
- UAS
- IHS4
All executed workflows returned structured clinical responses without runtime failures.
AI/ML Model Runtime Availability
Regulatory objective: Confirm availability of AI/ML models required for clinical workflows at runtime.
- Clinical AI/ML models are successfully loaded and running
- Non-clinical AI/ML models (including image quality and modality checks) are successfully loaded and running
Clinical Output Integrity and Structure
Regulatory objective: Confirm that clinical outputs are interpretable and structurally correct.
- Diagnosis support workflows produced responses conforming to the documented response schema.
- Severity assessment workflows produced responses conforming to the documented response schema.
- No runtime errors were observed during output generation.
Report Generation and Serialization
Regulatory objective: Confirm readiness of the reporting layer.
- Canonical clinical reports were generated successfully in JSON format.
- No additional report formats (FHIR, XML, PDF) were applicable for this release.
Operational Readiness Checks
Regulatory objective: Confirm operational conditions required for safe clinical use at release time.
- Monitoring was enabled at commissioning time.
- Logging was enabled at commissioning time.
- During commissioning execution of clinical workflows, no unhandled errors, service crashes, or unexpected terminations were observed; error handling behaved as controlled.
Clinical Workflow Limitations and Known Constraints
Regulatory objective: Ensure transparency regarding clinical workflow constraints at release time.
- No known clinical workflow limitations were identified at commissioning time.
Evidence Register
Regulatory objective: Identify controlled locations where clinical commissioning evidence can be retrieved.
| Evidence type | Location / system of record | Notes |
|---|---|---|
| End-to-end workflow execution evidence | DynamoDB; S3 bucket: s3://legit-health-plus/software-tests/v1.1.0.0/production/commissioning/testrail/ | Request identifiers and full execution logs for Diagnosis and Severity workflows (PASI, SCORAD, UAS, IHS4). |
| Sample clinical responses | Controlled commissioning artifact repository (S3) | Synthetic commissioning JSON responses used to verify diagnostic and severity output integrity (EV-STR-01, EV-REP-01). |
| AI/ML model readiness evidence | Docker logs (EC2); Health endpoint (/device/health) | Confirms successful model download from S3 and initialization of all 58 experts at startup (EV-MOD-01, EV-MOD-02). |
| Monitoring / health evidence | AWS CloudWatch (Synthetics); Local Docker logs | Proves active monitoring of production availability (EV-OPS-01) and internal service integration via docker logs (EV-OPS-02). |
| Audit trail and record persistence | DynamoDB table legit_health_plus_api_gateway_calls | Immutable records of clinical requests, including unique request IDs and execution timestamps (EV-OPS-03). |
| Commissioning records | Controlled QMS document repository | Includes the signed R-TF-029-003 record and formal acceptance evidence (EV-ACC-01). |
Deviations
Regulatory objective: Ensure transparency of commissioning execution.
- No deviations were observed during clinical workflow and operational readiness commissioning.
Clinical Commissioning Acceptance
Regulatory objective: Formally confirm readiness for clinical operation.
Acceptance statement:
The deployed software instance has been commissioned and confirmed to execute the intended clinical workflows, load required models at runtime, and produce structured clinical outputs consistent with the approved intended use in the production environment.
Record Status
This commissioning record establishes clinical workflow and operational readiness for the specified software version in accordance with ISO 62304 and ISO 82304-1.
Signature meaning
The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:
- Author: Team members involved
- Reviewer: JD-003, JD-004
- Approver: JD-001
Appendix A: Clinical Workflow Execution Log — Release 1.1.0.0
Regulatory objective: Provide detailed traceability of all commissioning test cases executed for clinical workflow validation.
The following table summarizes all test cases executed during the clinical workflow and operational readiness commissioning phase:
Legend:
- Title: Name and identifier of the test case
- URL: Link to the test case in the TestRail system
- Expected Results: Summary of expected outcomes for the test case
- Evidence URI: Location of the commissioning evidence artifacts in the S3 repository