R-TF-029-003 — Clinical Workflow & 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
- AWOSI
- SALT
- NSIL
- GPPGA
- ALADIN
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 were successfully loaded on demand from S3 during workflow execution.
- Non-clinical AI/ML models (including image quality and modality checks) were successfully loaded on demand from S3 during workflow execution.
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 | Request identifiers and execution logs |
| Sample clinical responses | Controlled commissioning artifact repository | Synthetic commissioning responses only |
| Monitoring / health evidence | AWS CloudWatch (metrics and logs for the commissioning execution window) | Health endpoint output and service health status |
| Commissioning records | Controlled QMS document repository | Includes R-TF-029-003 |
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