R-TF-012-034 Software Test Description

Document Information

Field	Value
Product / System	Legit.Health Plus
Release version	1.1.0.0
Commit SHA	5f8549e02f3f362db8930906cf6dfdedf232119a
Test management system	TestRail — Project “Medical Device”, Suite “Master”
Prepared by	Gerardo Fernández Moreno (JD-007)
Date	2026-01-02
Reviewed/Approved by	Alejandro Carmena
Review/Approval date	2026-01-10

Purpose

This document provides the controlled test case inventory (“what tests exist”) used to verify the software requirements for the release identified above.

This document is intentionally non-duplicative:

• The verification strategy, governance, execution rules, evidence expectations, environments, and retention are defined in R-TF-012-033 — Software Test Plan.
• The test specifications (preconditions, expected results, required evidence, requirement mapping, etc.) are maintained as controlled records in TestRail.

Scope

In scope for this Test Description:

• Automated Unit and Integration test suites maintained in the source code repository, providing low-level verification of software units and internal service interfaces.
• Verification test cases for Legit.Health Plus (all TestRail sections used for requirements verification).
• Commissioning (operational readiness) test cases executed for the deployed release, aligned with the commissioning records set (R-TF-029-001/002/003).
• Verification of container image integrity for images built directly on the production host, utilizing local Image IDs for traceability.

Out of scope:

• Test execution results (those are captured in TestRail runs and in the evidence pack).
• Defect reports (tracked separately as defined in the Test Plan).
• Intentional failure mode testing (e.g., downstream timeouts, partial expert failures), which is addressed in separate verification activities.

Terms and Definitions

• Test case: A controlled specification of verification steps and objective pass/fail criteria, including required evidence and requirement linkage.
• Test run: An execution instance of a selected set of test cases for a specific purpose and environment, producing execution results and evidence.
• Test plan (TestRail object): A container grouping multiple runs for the same {release_version} and environment, supporting a structured verification campaign.
• Commissioning: Operational readiness verification of the deployed release prior to enabling/confirming clinical use in the target environment, executed under controlled conditions and recorded in R-TF-029-00X.
• Audit Record: An immutable log entry in DynamoDB (table legit_health_plus_api_gateway_calls) containing a unique Request ID and execution timestamp used to prove clinical workflow traversal.
• Automated Test Suite: A collection of programmatic test scripts (Unit/Integration) executed within the development or CI environment to verify granular software logic and internal component communication.

Test Case Inventory and Control Method

Verification Test Cases (TestRail)

Authoritative source: The authoritative test specifications for system-level and commissioning verification are the TestRail test cases in Project "Medical Device".

Controlled inventory snapshot: For each release verification campaign, the test case inventory is captured as a controlled export (CSV) and stored alongside the Software Test Plan annexes and/or the release evidence pack. This document is considered complete only when its annexes (listed below) are stored together with it in the QMS record set.

Automated Test Suites (Source Repository)

Authoritative source: Unit and integration test cases are maintained as pytest test modules within each software component's tests/unit/ and tests/integration/ directories in the source code repository.

Software components under automated test:

Component	Unit Tests	Integration Tests
api_gateway	✓	✓
control_plane	✓	✓
report_builder	✓	✓
orchestrator	✓	✓
condition_classifier	✓	✓
essentials	✓	—
expert_core	✓	✓

Controlled inventory: The test case inventory for each release is established by the git commit under test. Test execution produces JUnit XML reports that enumerate all executed test cases, stored alongside coverage reports in the S3 evidence location referenced in R-TF-012-035.

Coverage statement

• Completeness of requirements coverage is demonstrated through the Traceability Matrix (Annex A) and its linkage to the TestRail test case identifiers and requirement IDs.
• Automated test suites provide additional depth of verification at the unit and integration level, complementing the requirements-based verification recorded in TestRail.

References

• R-TF-012-033 — Software Test Plan (verification strategy, governance, environments, evidence packs, retention).
• R-TF-029-001 Deployment and Configuration Commissioning Record
• R-TF-029-002 Functional and Interface Commissioning Record
• R-TF-029-003 Clinical Workflow and Operational Readiness Commissioning Record
• Test case inventory sources (controlled exports):
  • Annex A: Traceability matrix
  • Annex B: Verification Test Cases Export
  • Annex C: Commissioning Test Cases Export

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 Design & Development Manager, JD-004 Quality Manager & PRRC
• Approver: JD-001 General Manager

Annexes

Annex A: Traceability matrix

SRS Id	SRS Name	Test Case Id	Test Case Title	Reviewer	Review Status	Test Case URL
SRS-7PJ	Network Service Exposure	C50	Verify the API service accepts incoming HTTP requests on the designated network port	Gerardo Fernández	Approved	View
SRS-AQM	Standard HTTP Status Code Usage	C62	Verify API returns 200 HTTP status codes for successful requests	Gerardo Fernández	Approved	View
SRS-BYJ	JSON Data Interchange Format	C68	Verify API processes JSON requests and returns JSON responses with correct Content-Type headers	Gerardo Fernández	Approved	View
SRS-DW0	User Authentication Endpoint Implementation	C77	Verify successful user authentication and token generation via the POST /auth/login endpoint	Gerardo Fernández	Approved	View
SRS-D3N	Provision of Clinical Parameter Endpoints	C73	Verify retrieval and filtering of clinical signs data via /clinical/severity-experts endpoint	Gerardo Fernández	Approved	View
SRS-LBS	URL-Based API Versioning	C106	Verify API endpoints are accessible via URL paths prefixed with the major and minor version identifier	Gerardo Fernández	Approved	View
SRS-MZC	Request Body Size Limitation	C110	Verify the API returns HTTP 413 when the request body exceeds the configured maximum size	Gerardo Fernández	Approved	View
SRS-Q9M	Clinical Signs Analysis Endpoint Implementation	C124	Verify POST /clinical/severity-assessment returns quantified results for valid image and sign list	Gerardo Fernández	Approved	View
SRS-RXK	Diagnostic Support Endpoint Implementation	C128	Verify the diagnosis-support endpoint accepts valid images and returns diagnostic analysis	Gerardo Fernández	Approved	View
SRS-ZQO	Concurrent API Version Support	C162	Verify simultaneous availability and processing of requests across distinct API versions	Gerardo Fernández	Approved	View
SRS-ID7	Input Data Validation	C330	Verify API rejects malformed inputs with standardized 422 Unprocessable Entity responses	Gerardo Fernández	Approved	View
SRS-EH4	Security-Safe Error Handling	C331	Verify API returns sanitized error responses with appropriate HTTP status codes and no internal details	Gerardo Fernández	Approved	View
SRS-AQM	Standard HTTP Status Code Usage	C454	Verify API returns 401 HTTP status codes for wrong login requests	Gerardo Fernández	Approved	View
SRS-AQM	Standard HTTP Status Code Usage	C455	Verify API returns 422 HTTP status code when invalid data is submitted	Gerardo Fernández	Approved	View
SRS-GER	System Behavior on Internal Component Failure.	C456	Verification of controlled 503 response and graceful degradation during downstream service failure.	Gerardo Fernández	Approved	View
SRS-6KE	API Health Check Endpoint	C169	Verify health check endpoint returns unhealthy when some service is unavailable	Gerardo Fernández	Approved	View
SRS-6KE	API Health Check Endpoint	C46	Verify the public health endpoint returns HTTP 200 and status OK when operational	Gerardo Fernández	Approved	View
SRS-BA6	Display the legal information about this medical device	C66	Verify retrieval of mandatory legal information, UDI, and regulatory metadata via API	Gerardo Fernández	Approved	View
SRS-Z24	API Documentation Endpoint	C159	Verify availability of OpenAPI specification and interactive documentation endpoints	Gerardo Fernández	Approved	View
SRS-Q3Q	Generate an aggregated ICD probability distribution from a set of images	C255	Verify API returns aggregated ICD probability distribution with structured code details in studyAggregate array	Gerardo Fernández	Approved	View
SRS-0AB	Generate per-image ICD analysis with explainability heat map	C256	Verify response includes per-image ICD probabilities and heat maps for the top five categories	Gerardo Fernández	Approved	View
SRS-58W	Include entropy score in report	C258	Verify response includes normalized entropy score between 0 and 1 in findings	Gerardo Fernández	Approved	View
SRS-71I	Include the indicator of needing a high priority referral in the report	C260	Verify report response includes highPriorityReferral score within riskMetrics object	Gerardo Fernández	Approved	View
SRS-8HY	Include the indicator of malignancy in the report	C261	Verify report response includes malignantConditionProbability score within riskMetrics object	Gerardo Fernández	Approved	View
SRS-D08	Include the indicator of the image presenting a pigmented lesion in the report	C262	Verify report response includes pigmentedLesion score within riskMetrics object	Gerardo Fernández	Approved	View
SRS-JLM	Include the indicator of the presence of a condition in the report	C263	Verify report response includes anyConditionProbability score within riskMetrics object	Gerardo Fernández	Approved	View
SRS-KAS	Include the indicator of needing an urgent referral in the report	C264	Verify report response includes urgentReferral score within riskMetrics object	Gerardo Fernández	Approved	View
SRS-K7M	Orchestrate diagnosis support workflow	C265	Verify diagnosis workflow returns ranked ICD-11 codes, binary indicators, and explainability maps for valid images	Gerardo Fernández	Approved	View
SRS-A9F	Wound Bed Tissue - Epithelial	C266	Verify epithelial tissue classification returns right presence prediction and confidence score	Gerardo Fernández	Approved	View
SRS-B3Z	Inflammatory Pattern Identification	C267	Verify API returns Hurley stage and inflammatory status with associated probabilities for valid image input	Gerardo Fernández	Approved	View
SRS-B6L	Wound Bed Tissue - Necrotic	C268	Verify tissue wound bed necrotic classification returns right presence prediction and confidence score	Gerardo Fernández	Approved	View
SRS-B8N	Pustule Intensity Quantification	C269	Verify pustule classification returns right intensity and confidence	Gerardo Fernández	Approved	View
SRS-A4W	Inflammatory Nodular Lesion Quantification	C270	Verify inflammatory nodular lesion detector return correct counts and bounding boxes for drainning tunnels	Gerardo Fernández	Approved	View
SRS-A6T	Delimited Wound Edges Assessment	C271	Verify wound borders delimited classification returns right presence prediction and confidence score	Gerardo Fernández	Approved	View
SRS-C1R	Serous Exudate Assessment	C272	Verify wound exudation serous classification returns right presence prediction and confidence score	Gerardo Fernández	Approved	View
SRS-D7N	Purulent Exudate Assessment	C274	Verify wound exudation purulent classification returns right presence prediction and confidence score	Gerardo Fernández	Approved	View
SRS-D9T	Maceration Surface Quantification	C275	Verify wound maceration segmentation analysis returns segmentation masks and the right percentage of surface affected	Gerardo Fernández	Approved	View
SRS-E4R	Erythema Intensity Quantification	C276	Verify erythema classification returns right intensity and confidence	Gerardo Fernández	Approved	View
SRS-Y6F	Crusting Intensity Quantification	C277	Verify crusting classification returns right intensity and confidence	Gerardo Fernández	Approved	View
SRS-F2K	Thickened Wound Edges Assessment	C278	Verify thickened wound borders classification returns right presence prediction and confidence score	Gerardo Fernández	Approved	View
SRS-T3K	Induration Intensity Quantification	C279	Verify induration classification returns right intensity and confidence	Gerardo Fernández	Approved	View
SRS-F6J	Hair Loss Surface Quantification	C280	Verify hair loss segmentation analysis returns segmentation masks and the right percentage of surface affected	Gerardo Fernández	Approved	View
SRS-G3P	Wound Perilesional Erythema Assessment	C281	Verify wound perilesional erythema classification returns right presence prediction and confidence score	Gerardo Fernández	Approved	View
SRS-G9R	Wound Stage Classification	C282	Verify wound stage classification returns right score and confidence metrics from a valid wound image	Gerardo Fernández	Approved	View
SRS-H5K	Erythema Surface Quantification	C283	Verify erythema segmentation analysis returns segmentation masks and the right percentage of surface affected	Gerardo Fernández	Approved	View
SRS-H9X	Lichenification Intensity Quantification	C284	Verify lichenification classification returns right intensity and confidence	Gerardo Fernández	Approved	View
SRS-I7T	Wound Affected Tissue - Intact Skin	C285	Verify wound affected tissues intact classification returns right presence prediction and confidence score	Gerardo Fernández	Approved	View
SRS-J5P	Hair Follicle Quantification	C286	Verify API returns follicle count, bounding boxes, and confidence scores for a valid scalp image	Gerardo Fernández	Approved	View
SRS-J9V	Indistinguishable Wound Edges Assessment	C287	Verify wound borders indistinguishable classification returns right presence prediction and confidence score	Gerardo Fernández	Approved	View
SRS-K3H	Wound Affected Tissue - Subcutaneous	C288	Verify wound affected tissues subcutaneous classification returns right presence prediction and confidence score	Gerardo Fernández	Approved	View
SRS-K4U	Orthopedic Material Surface Quantification	C289	Verify wound orthopedic material segmentation analysis returns segmentation masks and the right percentage of surface affected	Gerardo Fernández	Approved	View
SRS-L4W	Damaged Wound Edges Assessment	C290	Verify wound borders damaged classification returns right presence prediction and confidence score	Gerardo Fernández	Approved	View
SRS-L8Y	Biofilm and Slough Surface Quantification	C291	Verify wound biofilm material segmentation analysis returns segmentation masks and the right percentage of surface affected	Gerardo Fernández	Approved	View
SRS-M2L	Xerosis Intensity Quantification	C292	Verify xerosis classification returns right intensity and confidence	Gerardo Fernández	Approved	View
SRS-M6P	Granulation Tissue Surface Quantification	C293	Verify wound granulation segmentation analysis returns segmentation masks and the right percentage of surface affected	Gerardo Fernández	Approved	View
SRS-N2C	Bone Surface Segmentation	C294	Verify wound bone segmentation analysis returns segmentation masks and the right percentage of surface affected	Gerardo Fernández	Approved	View
SRS-N5Q	Swelling Intensity Quantification	C295	Verify swelling classification returns right intensity and confidence	Gerardo Fernández	Approved	View
SRS-N8W	Wound Affected Tissue - Dermis-Epidermis	C296	Verify wound exudation serous classification returns right presence prediction and confidence score	Gerardo Fernández	Approved	View
SRS-O5M	Wound Affected Tissue - Muscle	C297	Verify wound affected tissues muscle classification returns right presence prediction and confidence score	Gerardo Fernández	Approved	View
SRS-L3X	Skin Surface Segmentation	C298	Verify skin segmentation analysis returns segmentation masks and the right percentage of surface affected	Gerardo Fernández	Approved	View
SRS-Z5N	Hive Lesion Quantification	C299	Verify hive detector return correct counts and bounding boxes for hives	Gerardo Fernández	Approved	View
SRS-Z8P	Biofilm-Compatible Tissue Assessment	C300	Verify wound biofilm tissue classification returns right presence prediction and confidence score	Gerardo Fernández	Approved	View
SRS-P4X	Wound Bed Tissue - Slough	C302	Verify tissue wound bed slough classification returns right presence prediction and confidence score	Gerardo Fernández	Approved	View
SRS-P9W	Desquamation Intensity Quantification	C303	Verify desquamation classification returns right intensity and confidence	Gerardo Fernández	Approved	View
SRS-Q1L	Hypopigmentation or Depigmentation Surface Quantification	C304	Verify hypopigmentation segmentation analysis returns segmentation masks and the right percentage of surface affected	Gerardo Fernández	Approved	View
SRS-Q8Z	Diffuse Wound Edges Assessment	C305	Verify wound borders diffused classification returns right presence prediction and confidence score	Gerardo Fernández	Approved	View
SRS-R3W	Wound Bed Surface Quantification	C306	Verify wound bed segmentation analysis returns segmentation masks and the right percentage of surface affected	Gerardo Fernández	Approved	View
SRS-R7C	Oozing Intensity Quantification	C307	Verify oozing classification returns right intensity and confidence	Gerardo Fernández	Approved	View
SRS-S2V	Wound Affected Tissue - Bone	C308	Verify wound affected tissues bone classification returns right presence prediction and confidence score	Gerardo Fernández	Approved	View
SRS-S8M	Acneiform Lesion Type Quantification	C309	Verify acneiform detector return correct counts and bounding boxes for papules, pustules, spots	Gerardo Fernández	Approved	View
SRS-T6H	Wound AWOSI Score Quantification	C310	Verify AWOSI classification returns right score and confidence metrics from a valid wound image	Gerardo Fernández	Approved	View
SRS-T9U	Wound Bed Tissue - Closed	C311	Verify tissue wound bed closed classification returns right presence prediction and confidence score	Gerardo Fernández	Approved	View
SRS-U4M	Perilesional Maceration Assessment	C312	Verify wound perilesional maceration classification returns right presence prediction and confidence score	Gerardo Fernández	Approved	View
SRS-U8Z	Nail Lesion Surface Quantification	C313	Verify nail lesion segmentation analysis returns segmentation masks and the right percentage of surface affected	Gerardo Fernández	Approved	View
SRS-V1D	Excoriation Intensity Quantification	C314	Verify excoriation classification returns right intensity and confidence	Gerardo Fernández	Approved	View
SRS-V7Q	Necrosis Surface Quantification	C315	Verify wound necrosis segmentation analysis returns segmentation masks and the right percentage of surface affected	Gerardo Fernández	Approved	View
SRS-W3R	Hyperpigmentation Surface Quantification	C316	Verify hyperpigmentation segmentation analysis returns segmentation masks and the right percentage of surface affected	Gerardo Fernández	Approved	View
SRS-W9K	Bloody Exudate Assessment	C317	Verify wound bloody exudation classification returns right presence prediction and confidence score	Gerardo Fernández	Approved	View
SRS-X5B	Fibrinous Exudate Assessment	C318	Verify wound exudation fibrinous classification returns right presence prediction and confidence score	Gerardo Fernández	Approved	View
SRS-X8Q	Follicular and Inflammatory Pattern Identification	C319	Verify follicular and inflammatory pattern identification returns right result	Gerardo Fernández	Approved	View
SRS-Y2E	Wound Bed Tissue - Granulation	C320	Verify wound tissue wound bed granulation classification returns right presence prediction and confidence score	Gerardo Fernández	Approved	View
SRS-W6T	Orchestrate Clinical Signs Analysis Workflow	C321	Verify generation of structured clinical assessment report with quantified results for requested signs via API	Gerardo Fernández	Approved	View
SRS-E1V	Body Surface Segmentation	C325	Verify body surface segmentation analysis returns segmentation masks and the right percentage of surface affected	Gerardo Fernández	Approved	View
SRS-S8M	Acneiform Lesion Type Quantification	C446	Verify acneiform detector return correct counts and bounding boxes for nodules, pustules and scabs	Gerardo Fernández	Approved	View
SRS-S8M	Acneiform Lesion Type Quantification	C447	Verify acneiform detector return correct counts and bounding boxes for scabs, comedones, papules and pustules	Gerardo Fernández	Approved	View
SRS-Z5N	Hive Lesion Quantification	C448	Verify hive detector return correct counts and bounding boxes for hives (second image)	Gerardo Fernández	Approved	View
SRS-A4W	Inflammatory Nodular Lesion Quantification	C449	Verify inflammatory nodular lesion detector return correct counts and bounding boxes for non drainning tunnels	Gerardo Fernández	Approved	View
SRS-A4W	Inflammatory Nodular Lesion Quantification	C450	Verify inflammatory nodular lesion detector return correct counts and bounding boxes for nodules	Gerardo Fernández	Approved	View
SRS-H2V	Head Detection	C323	Verify head detection returns right bounding boxes and heads count inside an image	Gerardo Fernández	Approved	View
SRS-9ZT	The product classifies the image's modality	C327	Verify API returns ""clinical"" for image modality category when a skin image is provided	Gerardo Fernández	Approved	View
SRS-O93	The product checks the image's clinical domain	C328	Verify API returns image domain category equals to ""dermatological"" and confidence score for a skin image	Gerardo Fernández	Approved	View
SRS-Y5W	The product checks the image quality with the Dermatological Image Quality Assessment (DIQA) algorithm	C329	Verify API returns dermatological image quality score, interpretation, and acquisition feedback	Gerardo Fernández	Approved	View
SRS-9ZT	The product classifies the image's modality	C451	Verify API returns ""dermoscopic"" for image modality category when a skin image is provided	Gerardo Fernández	Approved	View
SRS-O93	The product checks the image's clinical domain	C452	Verify API returns image domain category equals to ""non_dermatological"" and confidence score for a dog image	Gerardo Fernández	Approved	View
SRS-F05	Generate FHIR DiagnosticReport Base Structure	C453	Verify FHIR DiagnosticReport base structure for a segmenter	Gerardo Fernández	Approved	View
SRS-1KW	Secure Communication Protocol Enforcement	C332	Verify API accepts requests over HTTPS using TLS 1.2 or 1.3	Gerardo Fernández	Approved	View
SRS-1KW	Secure Communication Protocol Enforcement	C333	Verify API rejects or redirects unencrypted HTTP requests	Gerardo Fernández	Approved	View
SRS-28X	Implement progressive delays between failed login attempts	C335	Verify progressive increase in enforced delay across consecutive failed authentication attempts	Gerardo Fernández	Approved	View
SRS-28X	Implement progressive delays between failed login attempts	C336	Verify delay resets upon successful authentication	Gerardo Fernández	Approved	View
SRS-A25	Role-Based Access Control (RBAC) with Least Privilege Principle to restrict users to essential functions	C337	Verify successful access to permitted endpoints for an authorized role	Gerardo Fernández	Approved	View
SRS-A25	Role-Based Access Control (RBAC) with Least Privilege Principle to restrict users to essential functions	C338	Verify access denial for endpoints outside the assigned role scope	Gerardo Fernández	Approved	View
SRS-A2B	API Rate Limiting	C339	Verify HTTP 403 response when request volume exceeds defined threshold	Gerardo Fernández	Approved	View
SRS-A2B	API Rate Limiting	C340	Verify request acceptance after rate limit time window expiration	Gerardo Fernández	Approved	View
SRS-MM8	Generated JWTs must have an expiration date	C341	Verify generated authentication tokens include the expiration claim	Gerardo Fernández	Approved	View
SRS-MM8	Generated JWTs must have an expiration date	C342	Verify access denial for requests using an expired JWT	Gerardo Fernández	Approved	View
SRS-SDZ	Use hashed and salted passwords	C343	Verify generation of authentication token using valid credentials	Gerardo Fernández	Approved	View
SRS-SDZ	Use hashed and salted passwords	C344	Verify rejection of authentication requests with invalid credentials	Gerardo Fernández	Approved	View
SRS-SDZ	Use hashed and salted passwords	C345	Verify password update functionality and subsequent authentication	Gerardo Fernández	Approved	View
SRS-TPK	Lock accounts after five failed attempts	C346	Verify account lockout enforcement after threshold reached	Gerardo Fernández	Approved	View
SRS-TPK	Lock accounts after five failed attempts	C347	Verify failed attempt counter reset on successful login	Gerardo Fernández	Approved	View
SRS-TPK	Lock accounts after five failed attempts	C348	Verify administrative manual account unlock capability	Gerardo Fernández	Approved	View
SRS-U8M	Enforce strong password policies (min. 12 characters, complexity rules, expiration policies)	C349	Verify enforcement of password complexity and length constraints	Gerardo Fernández	Approved	View
SRS-U8M	Enforce strong password policies (min. 12 characters, complexity rules, expiration policies)	C350	Verify authentication behavior for expired passwords	Gerardo Fernández	Approved	View
SRS-WER	Endpoint Access Control	C351	Verify protected endpoints allow access with a valid OAuth 2.0 Bearer token	Gerardo Fernández	Approved	View
SRS-WER	Endpoint Access Control	C352	Verify protected endpoints reject requests lacking a valid token with 401 Unauthorized	Gerardo Fernández	Approved	View
SRS-WER	Endpoint Access Control	C353	Verify public endpoints are accessible without an Authorization header	Gerardo Fernández	Approved	View
SRS-WGF	AES-256 encryption for data at rest	C354	Verify AES-256 encryption configuration for data storage	Gerardo Fernández	Approved	View
SRS-X9J	Conduct periodic access reviews to verify permissions align with job functions	C355	Verify authorized administrator can retrieve current user information for review	Gerardo Fernández	Approved	View
SRS-X9J	Conduct periodic access reviews to verify permissions align with job functions	C356	Verify authorized administrator can revoke permissions during access review	Gerardo Fernández	Approved	View
SRS-IC4	Software and Configuration Integrity Verification	C357	Verify successful execution and audit logging of system integrity checks	Gerardo Fernández	Approved	View
SRS-BK7	Encrypted Backup and Integrity Verification	C363	Verify backup generation	Gerardo Fernández	Approved	View
SRS-BK7	Encrypted Backup and Integrity Verification	C364	Verify automated backup generation	Gerardo Fernández	Approved	View
SRS-CCD	Intrusion Prevention and Malicious Traffic Detection	C366	Verify blocking of anomalous high-frequency request bursts	Gerardo Fernández	Approved	View
SRS-F05	Generate FHIR DiagnosticReport Base Structure	C368	Verify FHIR DiagnosticReport base structure for a detector	Gerardo Fernández	Approved	View
SRS-FMG	Record Analysis Duration in Report	C369	Verify analysisDuration field population in DiagnosticReport	Gerardo Fernández	Approved	View
SRS-JC6	The product provides a final image validity summary	C370	Verify isAssessable is true when domain and quality criteria are met	Gerardo Fernández	Approved	View
SRS-JC6	The product provides a final image validity summary	C371	Verify isAssessable is false when image quality is unacceptable	Gerardo Fernández	Approved	View
SRS-JC6	The product provides a final image validity summary	C372	Verify isAssessable is false when image is non-dermatological	Gerardo Fernández	Approved	View
SRS-K6N	Map Per-Image Analysis to a dedicated object in the report	C373	Verify single image analysis maps to structured object in imageAnalyses array	Gerardo Fernández	Approved	View
SRS-K6N	Map Per-Image Analysis to a dedicated object in the report	C374	Verify multiple image analyses map to distinct objects in imagingAnalysis array	Gerardo Fernández	Approved	View
SRS-H3J	Deterministic Response Schemas	C375	Verify response structure compliance with OpenAPI success schema	Gerardo Fernández	Approved	View
SRS-H3J	Deterministic Response Schemas	C376	Verify response structure compliance with OpenAPI error schema	Gerardo Fernández	Approved	View
SRS-W5Z	Assign DiagnosticReport Identifier	C377	Verify Assignment of Official Identifier to DiagnosticReport	Gerardo Fernández	Approved	View
SRS-W5Z	Assign DiagnosticReport Identifier	C378	Verify Uniqueness of Generated DiagnosticReport Identifiers	Gerardo Fernández	Approved	View
SRS-D6W	Accurate Time Synchronization	C382	Verify System Timestamp Accuracy via API Response Headers	Gerardo Fernández	Approved	View
SRS-D6W	Accurate Time Synchronization	C383	Verify System Time Synchronization and Accuracy Status	Gerardo Fernández	Approved	View
SRS-SI2	Secure Audit Trail Access Interface	C388	Verify Role-Based Access Control for Audit Trail Interface	Gerardo Fernández	Approved	View
SRS-SI2	Secure Audit Trail Access Interface	C389	Verify Audit Trail Search and Export Capabilities	Gerardo Fernández	Approved	View
SRS-T5P	Audit Record Integrity Protection	C391	Verify audit records cannot be modified or deleted via API	Gerardo Fernández	Approved	View
SRS-PU2	Comprehensive Event Auditing	C395	Verify audit trail generation for authentication lifecycle and security anomalies	Gerardo Fernández	Approved	View
SRS-U2P	Consolidated Audit Record Content	C398	Verify audit record completeness for successful API event	Gerardo Fernández	Approved	View
SRS-U2P	Consolidated Audit Record Content	C399	Verify audit record completeness for failed API event	Gerardo Fernández	Approved	View
SRS-PU2	Comprehensive Event Auditing	C410	Verify audit trail generation for clinical data creation events	Gerardo Fernández	Approved	View
SRS-T95	Audit System Failure Handling	C413	Audit record preservation during database unavailability	Gerardo Fernández	Approved	View
SRS-BWB	Performance and Latency	C416	Verify p95 API latency remains under 10 seconds during nominal load	Gerardo Fernández	Approved	View

Annex B: Verification Test Cases Export

• File: test_rail_verification_tests.csv

Annex C: Commissioning Test Cases Export

• File: test_rail_commissioning_tests.csv