R-TF-029-001 — Deployment and Configuration Commissioning Record
Document Control
- Record ID: R-TF-029-001
- Template Reference: T-029-001 — Deployment & Configuration 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 the approved software release baseline and the deployed production instance (ISO 62304 §5.8).
| Item | Value |
|---|---|
| Device name | Legit.Health Plus |
| Software version | 1.1.0.0 |
| Internal release identifier | 1.1.0.0 |
| Deployment date | Pending |
| AWS region | eu-west-3 |
| AWS account identifier | 949243942475 |
Deployment Environment Verification
Regulatory objective: Confirm that the software has been deployed in the intended and controlled production environment and that the deployment boundary matches the approved deployment model (ISO 82304-1 §7.3 intent).
Declared production environment (as commissioned):
- Compute environment: EC2 instance
- Instance name: Legit.Health Plus
- Instance type: g6.8xlarge
- Deployment type: Production-only
Commissioning verification performed:
- Confirmed that the production environment identifiers (AWS account + region) match the approved production target.
- Confirmed that the services required for device operation were deployed in the declared production environment.
Evidence reference(s): EV-001 (environment identifiers), EV-002 (service status snapshot)
Container Image Verification
Regulatory objective: Confirm that the deployed software corresponds exactly to the released software baseline (ISO 62304 §5.8).
Verification method (controlled):
- Container images were built directly on the production host from approved source code tags.
- Deployed image identity is confirmed using local Image IDs.
Images were built locally on the production server using Bazel to meet release requirements; traceability is maintained via local Image IDs instead of ECR Digests.
| Image name | Image tag | Local image id | Verification result | Evidence reference |
|---|---|---|---|---|
| 949243942475.dkr.ecr.eu-west-3.amazonaws.com/legit-health-plus/base-classifier-runtime | 1.0.0 | 7d42ed74eebf | Verified (local image present) | docker images |
| 949243942475.dkr.ecr.eu-west-3.amazonaws.com/legit-health-plus/base-segmenter-runtime | 1.0.0 | f35b59b0779b | Verified (local image present) | docker images |
| acneiform-detector | 1.0.0 | abb296229eb4 | Verified (local image present) | docker images |
| api-gateway | 1.0.0 | 27184bb77e3b | Verified (local image present) | docker images |
| awosi-classifier | 1.0.0 | abe0bc65c01a | Verified (local image present) | docker images |
| base-classifier-runtime | 1.0.0 | 7d42ed74eebf | Verified (local image present) | docker images |
| base-segmenter-runtime | 1.0.0 | b1373d72ac24 | Verified (local image present) | docker images |
| body-surface-segmenter | 1.0.0 | 5bb22dd7b9c7 | Verified (local image present) | docker images |
| condition-classifier | 1.0.0 | 2049781a1de4 | Verified (local image present) | docker images |
| control-plane | 1.0.0 | e4c41dca8784 | Verified (local image present) | docker images |
| crusting-classifier | 1.0.0 | db615e726fdd | Verified (local image present) | docker images |
| desquamation-classifier | 1.0.0 | aa14f1f147aa | Verified (local image present) | docker images |
| erythema-classifier | 1.0.0 | 626164e85fd6 | Verified (local image present) | docker images |
| erythema-segmenter | 1.0.0 | 86e5c271173f | Verified (local image present) | docker images |
| excoriation-classifier | 1.0.0 | ced4df8e98ca | Verified (local image present) | docker images |
| expert-orchestrator | 1.0.0 | 609c7bcab06b | Verified (local image present) | docker images |
| follicular-inflammatory-pattern-classifier | 1.0.0 | 96c6e60e8adc | Verified (local image present) | docker images |
| hair-follicle-detector | 1.0.0 | 2401a0573efa | Verified (local image present) | docker images |
| hair-loss-segmenter | 1.0.0 | 69e3491e45d4 | Verified (local image present) | docker images |
| head-detector | 1.0.0 | b9fbbaf6b0a2 | Verified (local image present) | docker images |
| hive-detector | 1.0.0 | 6021f79d00e1 | Verified (local image present) | docker images |
| hyperpigmentation-segmenter | 1.0.0 | 5993385a6576 | Verified (local image present) | docker images |
| hypopigmentation-segmenter | 1.0.0 | 6c0be35c21d5 | Verified (local image present) | docker images |
| image-domain-modality-classifier | 1.0.0 | ac7cbe83e09d | Verified (local image present) | docker images |
| image-quality | 1.0.0 | fc1efb0ac3c2 | Verified (local image present) | docker images |
| induration-classifier | 1.0.0 | e51a3fb085b7 | Verified (local image present) | docker images |
| inflammatory-nodular-lesion-detector | 1.0.0 | 5e8f967dfde4 | Verified (local image present) | docker images |
| inflammatory-pattern-identificator | 1.0.0 | 21cd33cc1849 | Verified (local image present) | docker images |
| lichenification-classifier | 1.0.0 | 6e53211276b0 | Verified (local image present) | docker images |
| nail-lesion-segmenter | 1.0.0 | 2397bbc4ffe5 | Verified (local image present) | docker images |
| oci-builder-bazel-amd64 | 1.0.0 | f35d904101b3 | Verified (local image present) | docker images |
| oozing-classifier | 1.0.0 | 06835e5b73b5 | Verified (local image present) | docker images |
| pustule-classifier | 1.0.0 | 1e3a049eb153 | Verified (local image present) | docker images |
| report-builder | 1.0.0 | 8451a403552a | Verified (local image present) | docker images |
| skin-segmenter | 1.0.0 | 302303097e78 | Verified (local image present) | docker images |
| swelling-classifier | 1.0.0 | 68c39c74c236 | Verified (local image present) | docker images |
| tissue-wound-bed-closed-classifier | 1.0.0 | 33d88bee07dd | Verified (local image present) | docker images |
| tissue-wound-bed-necrotic-classifier | 1.0.0 | e00e94a99e3f | Verified (local image present) | docker images |
| web-api-gateway | 1.0.0 | 20b9f27f5150 | Verified (local image present) | docker images |
| wound-affected-tissues-bone-classifier | 1.0.0 | 5bf154c0612a | Verified (local image present) | docker images |
| wound-affected-tissues-dermis-epidermis-classifier | 1.0.0 | 4aae78cb6b47 | Verified (local image present) | docker images |
| wound-affected-tissues-intact-classifier | 1.0.0 | 12c25009dd11 | Verified (local image present) | docker images |
| wound-affected-tissues-muscle-classifier | 1.0.0 | bfffd21db42a | Verified (local image present) | docker images |
| wound-affected-tissues-subcutaneous-classifier | 1.0.0 | 947a606a8093 | Verified (local image present) | docker images |
| wound-bed-segmenter | 1.0.0 | 28bf113080ad | Verified (local image present) | docker images |
| wound-biofilm-segmenter | 1.0.0 | 3f64adebeadf | Verified (local image present) | docker images |
| wound-biofilm-tissue-classifier | 1.0.0 | afc62e53d1b2 | Verified (local image present) | docker images |
| wound-bone-segmenter | 1.0.0 | b6de5a20f522 | Verified (local image present) | docker images |
| wound-borders-damaged-classifier | 1.0.0 | d4eb3357eb4f | Verified (local image present) | docker images |
| wound-borders-delimited-classifier | 1.0.0 | 74b397c13550 | Verified (local image present) | docker images |
| wound-borders-diffused-classifier | 1.0.0 | df4fb36491b3 | Verified (local image present) | docker images |
| wound-borders-indistinguishable-classifier | 1.0.0 | 7680cdba6c06 | Verified (local image present) | docker images |
| wound-borders-thickened-classifier | 1.0.0 | 3dbff1819f2c | Verified (local image present) | docker images |
| wound-granulation-segmenter | 1.0.0 | 93bf8f0e3434 | Verified (local image present) | docker images |
| wound-maceration-segmenter | 1.0.0 | bdc74e245399 | Verified (local image present) | docker images |
| wound-necrosis-segmenter | 1.0.0 | 56ccd7a0d5d9 | Verified (local image present) | docker images |
| wound-orthopedic-segmenter | 1.0.0 | 5e4c548e7ef3 | Verified (local image present) | docker images |
| wound-perilesional-erythema-classifier | 1.0.0 | ad3c6fa03dee | Verified (local image present) | docker images |
| wound-perilesional-maceration-classifier | 1.0.0 | ba75d674a143 | Verified (local image present) | docker images |
| wound-stage-classifier | 1.0.0 | 0917e684465f | Verified (local image present) | docker images |
| wound-tissue-wound-bed-epithelial-classifier | 1.0.0 | 0fc568cb9e0c | Verified (local image present) | docker images |
| wound-tissue-wound-bed-granulation-classifier | 1.0.0 | dd503d2c45b1 | Verified (local image present) | docker images |
| wound-tissue-wound-bed-slough-classifier | 1.0.0 | c298430cc8a3 | Verified (local image present) | docker images |
| wound-type-exudation-bloody-classifier | 1.0.0 | f7891acb2d8f | Verified (local image present) | docker images |
| wound-type-exudation-fibrinous-classifier | 1.0.0 | 6f25a6d3115f | Verified (local image present) | docker images |
| wound-type-exudation-purulent-classifier | 1.0.0 | 9df186d75aad | Verified (local image present) | docker images |
| wound-type-exudation-serous-classifier | 1.0.0 | efc820996abe | Verified (local image present) | docker images |
| xerosis-classifier | 1.0.0 | d3788e37f3a8 | Verified (local image present) | docker images |
Execution note: Image digests and repositories are filled at deployment execution time and become part of the release evidence set.
Configuration Baseline Verification
Regulatory objective
Confirm that runtime configuration is complete, controlled, and appropriate for production use (ISO 82304-1 §7.3 intent), establishing a baseline for maintenance.
Configuration management mechanisms
- Primary: Local
.envfile (sourced from.env.example) - Environment Injection: Docker Compose environment variable mapping
Configuration assertions (verified)
- Credential Isolation: No hard-coded credentials exist in application code or container images.
- Secrets Externalization: All sensitive credentials (specifically
AWS_ACCESS_KEY_IDandAWS_SECRET_ACCESS_KEY) are externalized to a protected local.envfile and injected at runtime. - Scope Control: No feature flags are enabled for this release; regulated product scope is fully active as defined in the service configurations.
- Parameter Integrity: All 60+ microservice-specific S3 model keys and timeout parameters match the approved clinical release baseline.
Baseline reference (to be used for reproducibility):
- Configuration baseline identifier: 3baae2e2a913ed2ea383494c0564ecc9b8cf1056edf50951071bd708d9a1f79e
Evidence reference(s)
- EV-004: Configuration baseline reference (Redacted
.envkey list). - EV-005: Secrets externalization confirmation (Verification that environment variables are not in plaintext source).
Security Configuration Verification
Regulatory objective: Confirm that safety-relevant security controls required for intended operation are active in the production environment (ISO 82304-1 §5.6 intent; operational environment readiness).
Security controls verified:
- TLS termination enabled via CloudFront using ACM-managed certificate.
- Authentication enforced on protected endpoints using JWT bearer tokens.
- Service-to-AWS access is controlled via environment variables injected from a protected .env file.
Evidence reference(s):
- EV-006 (TLS/CloudFront configuration reference)
- EV-007 (auth enforcement confirmation)
- EV-008 (IAM role assignment reference)
External Dependency Availability
Regulatory objective
Confirm availability of external dependencies required for intended operation at commissioning time.
Verified at commissioning time:
- S3 model artifact buckets: Reachable and readable using credentials provided in the
.envfile; successful model loading confirmed for all clinical workflows. - DynamoDB tables: Reachable and writable for audit logging and API gateway record persistence.
- External Base Images: Reachable for local build processes (e.g., Docker Hub, NVIDIA container registry).
Evidence Register
Regulatory objective: Identify controlled locations where deployment commissioning evidence can be retrieved.
| Evidence type | Location / system of record | Notes |
|---|---|---|
| Infrastructure verification evidence | AWS EC2 / S3 Console; s3://legit-health-plus/software-tests/v1.1.0.0/production/commissioning/testrail/ | Verification of instance types, region, and S3 bucket availability (EV-ENV, EV-DEP). |
| Container image and baseline artifacts | Docker Registry; .env file configuration | SHA-256 digests and environment variable baseline for version 1.1.0.0 (EV-IMG, EV-CFG). |
| Security and access evidence | AWS IAM Console; Security Group Logs | Verification of Principle of Least Privilege and restricted port access (EV-SEC). |
| Deployment records and acceptance | Controlled QMS document repository | Includes the finalized R-TF-029-001 record (EV-ACC-01) and deviations review (EV-DEV-01). |
Deployment Deviations
Regulatory objective: Ensure transparency of deviations identified during commissioning.
☑ No deviations were identified during deployment and configuration commissioning.
(If deviations occur: record deviation ID, impact assessment, resolution, and evidence reference.)
Deployment Acceptance
Regulatory objective: Formally confirm that deployment and configuration commissioning requirements have been satisfied.
Acceptance statement: The deployed software instance corresponding to release 1.1.0.0 has been verified to be correctly installed, configured, and secured in the intended production environment and is accepted for operational use.
Record Status
This commissioning record establishes the deployed configuration baseline for maintenance and future releases 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: Infrastructure Deployment and Environment Verification Log
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