T-029-003 — Clinical Workflow & Operational Readiness Commissioning Template
1. Document Control
- Document ID: T-029-003
- Title: Clinical Workflow & Operational Readiness Commissioning
- Device: Legit.Health Plus
- Document Type: Commissioning Template
- Lifecycle Phase: Release / Commissioning
- Standard(s): ISO 62304, ISO 82304-1
Regulatory purpose: This document defines the controlled commissioning activities required to confirm that the deployed software instance is operationally ready to support its intended clinical use, executing complete clinical workflows and producing clinically interpretable outputs under real operating conditions.
2. Scope
This template applies to commissioning of:
- End-to-end clinical workflows exposed by the API
- Runtime availability of AI/ML models required for clinical outputs
- Report generation, aggregation, and serialization
- Operational readiness elements directly impacting safe clinical use
This template does not cover:
- Clinical performance validation (sensitivity, specificity, accuracy)
- Algorithm training or model development activities
- Post-market surveillance or real-world performance monitoring
3. Normative Basis
This commissioning activity satisfies the following normative intents:
- ISO 82304-1 §7.2: Validation of the health software product in its operational environment
- ISO 82304-1 §8.1: Confirmation that the product performs as intended when provided for use
- ISO 62304 §5.8: Release readiness including correct operation of the complete system
4. Inputs and Preconditions
The following shall be completed prior to execution:
- Completed R-TF-029-001 (Deployment & Configuration Commissioning)
- Completed R-TF-029-002 (Functional & Interface Commissioning)
- Approved intended use statement for the device
- Representative commissioning test data suitable for clinical workflow execution
5. Device and Release Identification
Objective: Ensure traceability between clinical commissioning results and the released software baseline.
| Item | Value |
|---|---|
| Device name | |
| Software version | |
| Internal release identifier | |
| Commissioning execution date | |
| Clinical workflows commissioned |
6. Intended Clinical Workflow Confirmation
Objective: Confirm that the commissioned workflows correspond to the approved intended use.
| Workflow ID | Workflow description | Intended use reference | In scope (Y/N) |
|---|---|---|---|
| CW-01 | Diagnosis support | ||
| CW-02 | Severity assessment |
7. End-to-End Clinical Workflow Execution
Objective: Confirm that complete clinical workflows execute successfully from input to output.
| Check ID | Clinical workflow | Scenario | Expected outcome | Actual outcome | Pass/Fail | Evidence reference |
|---|---|---|---|---|---|---|
| E2E-01 | Diagnosis support | Valid commissioning input | Structured clinical report returned | |||
| E2E-02 | Severity assessment | Valid commissioning input | Severity assessment report returned |
8. AI/ML Model Runtime Availability
Objective: Confirm that all AI/ML models required for clinical workflows are available and loadable at runtime.
| Model group | Loading mechanism | Availability confirmed (Y/N) | Notes |
|---|---|---|---|
| Clinical models | S3 load at startup/on demand | ||
| Non-clinical models | S3 load at startup/on demand |
9. Clinical Output Integrity and Structure
Objective: Confirm that clinical outputs are complete, interpretable, and structurally correct.
Verification criteria:
- Outputs are returned in the documented response schema
- Reports contain structured clinical elements (e.g. findings, scores, metadata)
- Outputs are generated without runtime errors
| Check ID | Workflow | Verification item | Result | Evidence reference |
|---|---|---|---|---|
| OUT-01 | Diagnosis support | Schema-conformant output | ||
| OUT-02 | Severity assessment | Schema-conformant output |
10. Report Generation and Serialization
Objective: Confirm correct generation and serialization of clinical reports.
| Check ID | Format | Expected result | Actual result | Pass/Fail | Evidence reference |
|---|---|---|---|---|---|
| REP-01 | JSON | Canonical report generated | |||
| REP-02 | Alternative formats (if applicable) | Report generated |
11. Operational Readiness Checks
Objective: Confirm readiness elements required for safe operational use.
| Check ID | Readiness element | Expected state | Actual state | Pass/Fail | Evidence reference |
|---|---|---|---|---|---|
| OP-01 | Monitoring enabled | Active | |||
| OP-02 | Logging enabled | Active | |||
| OP-03 | Error handling active | Controlled behavior |
12. Clinical Workflow Limitations and Known Constraints
Objective: Document any known constraints relevant to clinical use at release time.
| Limitation ID | Description | Impact on use | Mitigation / notes |
|---|
☐ No known limitations identified at commissioning time
13. Evidence Register
Objective: Identify where clinical commissioning evidence can be retrieved.
| Evidence type | Location / system of record | Notes |
|---|---|---|
| End-to-end workflow execution logs | ||
| Clinical response samples | ||
| Monitoring / health evidence | ||
| Commissioning records | QMS document repository |
14. Deviations
Objective: Record any deviations observed during clinical workflow commissioning.
| Deviation ID | Description | Impact assessment | Resolution | Status | Evidence reference |
|---|
☐ No deviations encountered
15. Clinical Commissioning Acceptance
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, and produce structured clinical outputs consistent with the approved intended use in the production environment.
| Role | Name | Date | Signature |
|---|---|---|---|
| Technical responsible | |||
| Quality / Regulatory |
16. Output
The completed commissioning record generated from this template shall be stored as R-TF-029-003 and maintained as part of the release evidence set for the commissioned software version.