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      • Deprecated
      • R-019-001 Software validation report_Atlassian_2023
      • R-019-001 Software validation report_HubSpot_2024
      • R-019-001 Software validation report_GitHub_GPG key signature_2024
      • R-019-001 Software validation report_Atlassian_2024
      • R-019-001 Software validation report_CVAT_2024
      • R-019-001 Software validation report_Docker_2024
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  • GP-019 Software validation
  • R-019-001 Software validation report_CVAT_2024

R-019-001 Software validation report_CVAT_2024

Scope​

The aim is to gather additional requirements and configuration specifications not encompassed within the application, together with their respective validations. This ensures adherence to both our internal requirements and those imposed by regulatory bodies. This involves detailing specifications and criteria which are external to the application but fundamental for ensuring our outputs align with all requisite standards and regulations.

Software description​

Name​

CVAT

Manufacturer​

Open source, maintained by Intel Corporation

Intended use​

The intended use CVAT is to annotate images for computer vision projects.

Testing details​

Software version​

  • Server version: 2.9.1
  • Core version: 12.1.0
  • Canvas version: 2.19.0
  • UI version: 1.59.0

Evaluation date​

2024-04-10

Risk-based analysis​

This software serves the purpose of annotating images. Its failure to correctly save and export the data inputted by healthcare professionals should not pose a risk to the development of high-quality deep learning models, as we have implemented rigorous procedures to thoroughly evaluate the performance of the models, guaranteeing that they meet all necessary requirements.

Requirements and design specification​

  • Requirement 01: A project can be created.
  • Requirement 02: Images can be loaded.
  • Requirement 03: Categorical data can be annotated.
  • Requirement 04: Images can be segmented.
  • Requirement 05: Objects can be annotated.
  • Requirement 06: Annotations are correctly stored.
  • Requirement 07: Annotations can be downloaded from the platform.

Assurance activities and test plan​

In addition to the tests and checks designed to ensure the configuration complies with the establised requirements, we have performed an assessment of the system capability (see R-002-007 Process validation card 2024_002) and a supplier evaluation (see R-010-001 Suppliers evaluation).

IDTest descriptionAcceptance criteriaRequirement tested
Test 01Create projectProject is correcly createdRequirement 01
Test 02Load imagesImages are successfully loadedRequirement 02
Test 03Create categorical annotationCategories are correctly annotatedRequirement 03
Test 04Segment an imageSegmentations are correctly annotatedRequirement 04
Test 05Annotate an objectObjects are correctly annotatedRequirement 05
Test 06Save annotationsAnnotations are correclty savedRequirement 06
Test 07Download annotationsAnnotations are correclty downloadedRequirement 07

Test Results and deviations detected​

Test 01​

  • Result: Pass
  • Deviation: No deviations found

evidence 1

Test 02​

  • Result: Pass
  • Deviation: No deviations found

evidence 2

Test 03​

  • Result: Pass
  • Deviation: No deviations found

evidence 3

Test 04​

  • Result: Pass
  • Deviation: No deviations found

evidence 4

Test 05​

  • Result: Pass
  • Deviation: No deviations found

evidence 5

Test 06​

  • Result: Pass
  • Deviation: No deviations found

evidence 6

Test 07​

  • Result: Pass
  • Deviation: No deviations found

evidence 7 evidence 8

Design review​

Result
Have the appropriate tasks and expected results, outputs, or products been established for each software life cycle activity?TRUE
Do the tasks and expected results, outputs, or products of each software life cycle activity:
Comply with the requirements of other software life cycle activities in terms of correctness, completeness, consistency, and accuracy?TRUE
Satisfy the standards, practices, and conventions of that activity?TRUE
Establish a proper basis for initiating tasks for the next software life cycle activity?TRUE

Conclusion​

No errors were detected in testing the CVAT functionalities related to the entire image annotation pipeline, including segmentation, object detection, and image recognition tasks.

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
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  • Scope
  • Software description
    • Name
    • Manufacturer
    • Intended use
  • Testing details
    • Software version
    • Evaluation date
  • Risk-based analysis
  • Requirements and design specification
  • Assurance activities and test plan
  • Test Results and deviations detected
    • Test 01
    • Test 02
    • Test 03
    • Test 04
    • Test 05
    • Test 06
    • Test 07
  • Design review
  • Conclusion
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.)