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QMSQMS
QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
  • Legit.Health Plus Version 1.1.0.0
    • Index of Technical Documentation or Product File
    • Summary of Technical Documentation (STED)
    • Description and specifications
    • R-TF-001-007 Declaration of conformity
    • GSPR
    • Clinical
    • Design and development
    • Design History File
      • Requirements
        • PRS
        • Deprecated Software Requirement Specification (SRS)
        • Software Requirement Specification (SRS)
          • SRS-001: Generate Automatic PASI (APASI) severity analysis report for single zone
          • SRS-002: Generate Automatic SCORAD (ASCORAD) severity analysis report for single zone
          • SRS-003: Generate Automatic Urticaria Activity Score (AUAS) report for single zone
          • SRS-004: Generate Automatic GPPGA (AGPPGA) report for single zone
          • SRS-005: Generate Automatic IHS4 (AIHS4) report for single zone
          • SRS-006: Generate ALADIN Score report for single zone
          • SRS-007: Generate Automatic VASI (AVASI) report for single zone
          • SRS-008: Generate Automatic AWOSI report for single zone
          • SRS-009: Generate Automatic NSIL report for single zone
          • SRS-010: Generate Automatic SALT (ASALT) report for single zone
          • SRS-011: Generate Automatic EASI (AEASI) report for single zone
          • SRS-012: Orchestrate severity analysis workflow
          • SRS-013 Generate an aggregated ICD probability distribution from image set
          • SRS-014 Generate per-image ICD analysis with explainability heat map
          • SRS-015 Generate an unified report of ICD class distributions
          • SRS-016: Include model sensitivity in report
          • SRS-017: Include model specificity in report
          • SRS-018: Include entropy score in report
          • SRS-019: Include the indicator of having a condition in the report
          • SRS-020: Include the indicator of the image presenting a pigmented lesion in the report
          • SRS-021: Include the indicator of malignancy in the report
          • SRS-022: Include the indicator of needing an urgent referral in the report
          • SRS-023: Include the indicator of needing a high priority referral in the report
          • SRS-024 The product validates the image with the AI LABS's Dermatological Image Quality Assessment (DIQA) algorithm
          • SRS-025 The product validates the image's clinical domain
          • SRS-026 The product classifies the image's modality
          • SRS-027 The product provides a final image validity summary
          • SRS-028: Orchestrate diagnosis support workflow
          • SRS-029: Compute 7-Point Checklist (7PC) Score
          • SRS-030: Compute Dermatology Life Quality Index (DLQI) Score
          • SRS-031: Compute PURE-4 Score
          • SRS-032: Compute Urticaria Control Test (UCT) Score
          • SRS-033: Calculate Global Acne Grading System (GAGS) Score
          • SRS-034: Calculate RESVECH Score
          • SRS-035: Calculate SCOVID Score
          • SRS-036: Calculate Physician's Global Assessment (PGA) Score
          • SRS-037: Generate Global Automatic VASI (AVASI) Score for Full Body
          • SRS-038: Secure Communication Protocol Enforcement
          • SRS-039: Network Service Exposure
          • SRS-040: URL-Based API Versioning
          • SRS-041: Concurrent API Version Support
          • SRS-042: JSON Data Interchange Format
          • SRS-043: Endpoint Implementation
          • SRS-044: Deterministic Response Schemas
          • SRS-045: Performance and Latency
          • SRS-046: Standard HTTP Status Code Usage
          • SRS-047: Endpoint Access Control
          • SRS-048: API Documentation Endpoint
          • SRS-049: High Availability and Load Balancing Support
          • SRS-050: Provision of Client SDKs for Integration
          • SRS-051: API Rate Limiting
          • SRS-052: Request Body Size Limitation
          • SRS-053: Provision of Clinical Parameter Endpoints
          • SRS-054: API Health Check Endpoint
        • missing-documents
      • Test plans
      • Test runs
      • Review meetings
      • 🥣 SOUPs
      • REL-001 Version 1.1.0.0
    • IFU and label
    • Post-Market Surveillance
    • Quality control
    • Risk Management
    • Usability and Human Factors Engineering
  • Legit.Health Plus Version 1.1.0.1
  • Licenses and accreditations
  • External documentation
  • Public tenders
  • Legit.Health Plus Version 1.1.0.0
  • Design History File
  • Requirements
  • Software Requirement Specification (SRS)

Software Requirement Specification (SRS)

📄️ SRS-001: Generate Automatic PASI (APASI) severity analysis report for single zone

Identifier

📄️ SRS-002: Generate Automatic SCORAD (ASCORAD) severity analysis report for single zone

Identifier

📄️ SRS-003: Generate Automatic Urticaria Activity Score (AUAS) report for single zone

Identifier

📄️ SRS-004: Generate Automatic GPPGA (AGPPGA) report for single zone

Identifier

📄️ SRS-005: Generate Automatic IHS4 (AIHS4) report for single zone

Identifier

📄️ SRS-006: Generate ALADIN Score report for single zone

Identifier

📄️ SRS-007: Generate Automatic VASI (AVASI) report for single zone

Identifier

📄️ SRS-008: Generate Automatic AWOSI report for single zone

Identifier

📄️ SRS-009: Generate Automatic NSIL report for single zone

Identifier

📄️ SRS-010: Generate Automatic SALT (ASALT) report for single zone

Identifier

📄️ SRS-011: Generate Automatic EASI (AEASI) report for single zone

Identifier

📄️ SRS-012: Orchestrate severity analysis workflow

Identifier

📄️ SRS-013 Generate an aggregated ICD probability distribution from image set

Identifier

📄️ SRS-014 Generate per-image ICD analysis with explainability heat map

Identifier

📄️ SRS-015 Generate an unified report of ICD class distributions

Identifier

📄️ SRS-016: Include model sensitivity in report

Identifier

📄️ SRS-017: Include model specificity in report

Identifier

📄️ SRS-018: Include entropy score in report

Identifier

📄️ SRS-019: Include the indicator of having a condition in the report

Identifier

📄️ SRS-020: Include the indicator of the image presenting a pigmented lesion in the report

Identifier

📄️ SRS-021: Include the indicator of malignancy in the report

Identifier

📄️ SRS-022: Include the indicator of needing an urgent referral in the report

Identifier

📄️ SRS-023: Include the indicator of needing a high priority referral in the report

Identifier

📄️ SRS-024 The product validates the image with the AI LABS's Dermatological Image Quality Assessment (DIQA) algorithm

Identifier

📄️ SRS-025 The product validates the image's clinical domain

Identifier

📄️ SRS-026 The product classifies the image's modality

Identifier

📄️ SRS-027 The product provides a final image validity summary

Identifier

📄️ SRS-028: Orchestrate diagnosis support workflow

Identifier

📄️ SRS-029: Compute 7-Point Checklist (7PC) Score

Identifier

📄️ SRS-030: Compute Dermatology Life Quality Index (DLQI) Score

Identifier

📄️ SRS-031: Compute PURE-4 Score

Identifier

📄️ SRS-032: Compute Urticaria Control Test (UCT) Score

Identifier

📄️ SRS-033: Calculate Global Acne Grading System (GAGS) Score

Identifier

📄️ SRS-034: Calculate RESVECH Score

Identifier

📄️ SRS-035: Calculate SCOVID Score

Identifier

📄️ SRS-036: Calculate Physician's Global Assessment (PGA) Score

Identifier

📄️ SRS-037: Generate Global Automatic VASI (AVASI) Score for Full Body

Identifier

📄️ SRS-038: Secure Communication Protocol Enforcement

Identifier

📄️ SRS-039: Network Service Exposure

Identifier

📄️ SRS-040: URL-Based API Versioning

Identifier

📄️ SRS-041: Concurrent API Version Support

Identifier

📄️ SRS-042: JSON Data Interchange Format

Identifier

📄️ SRS-043: Endpoint Implementation

Identifier

📄️ SRS-044: Deterministic Response Schemas

Identifier

📄️ SRS-045: Performance and Latency

Identifier

📄️ SRS-046: Standard HTTP Status Code Usage

Identifier

📄️ SRS-047: Endpoint Access Control

Identifier

📄️ SRS-048: API Documentation Endpoint

Identifier

📄️ SRS-049: High Availability and Load Balancing Support

Identifier

📄️ SRS-050: Provision of Client SDKs for Integration

Identifier

📄️ SRS-051: API Rate Limiting

Identifier

📄️ SRS-052: Request Body Size Limitation

Identifier

📄️ SRS-053: Provision of Clinical Parameter Endpoints

Identifier

📄️ SRS-054: API Health Check Endpoint

Identifier

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SRS-008 The user's password is stored in the database as a hashed password
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SRS-001: Generate Automatic PASI (APASI) severity analysis report for single zone
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI LABS GROUP S.L.)