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  • Welcome to your QMS
  • Quality Manual
  • Procedures
    • GP-001 Control of documents
    • GP-002 Quality planning
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 Human Resources and Training
    • GP-006 Non-conformity, Corrective and Preventive actions
    • GP-007 Post-market surveillance
    • GP-008 Product requirements
    • GP-009 Sales
    • GP-010 Purchases and suppliers evaluation
    • GP-011 Provision of service
    • GP-012 Design, redesign and development
      • Deprecated
      • Templates
        • T-012-004 Software version release
        • T-012-005 Design change control
        • T-012-006 _Product name_ life cycle plan and report_YYYY_nnn
        • T-012-007 Formative evaluation plan_YYYY_nnn
        • T-012-008 Formative evaluation report_YYYY_nnn
        • T-012-009 Validation and testing of machine learning models_YYYY_nnn
        • T-012-010 Device backup verification_YYYY_nnn
        • T-012-012 Customers product version control_YYYY_nnn
        • T-012-013 Design stage review
        • T-012-014 Summative evaluation plan_YYYY_nnn
        • T-012-015 Summative evaluation report YYYY_nnn
        • T-012-016 Software usability test guide
        • T-012-017 Integration test review
        • T-012-019 SOUP
        • T-012-020 Predetermined Change Control Plan
        • T-012-021 Product Design Phase 1 Checklist
        • T-012-022 Software Design Phase 2 Checklist
        • T-012-023 Software Development Plan
        • T-012-024 Software Candidate Release Phase 3 Checklist
        • T-012-025 Software Verification Phase 4 Checklist
        • T-012-026 Product Validation Phase 5 Checklist
        • T-012-028 Software Requirement Specification
        • T-012-029 Software Architecture Description
        • T-012-030 Software Configuration Management Plan
        • T-012-031 Product Requirements Specification
        • T-012-033 Software Tests Plan
        • T-012-034 Software Test Description
        • T-012-035 Software Test Run
        • T-012-037 Labeling and IFU Requirements
        • T-012-038 Verified Version Release
        • T-012-039 Validated Version Transfer
        • T-012-040 Documentation level FDA
        • T-012-041 Software Classification 62304
        • T-012-042 Regulatory Requirement
        • T-012-043 Traceability Matrix
      • GP-012 [Old version] Design, Redesign and Development
      • Specific procedures
    • GP-013 Risk management
    • GP-014 Feedback and complaints
    • GP-015 Clinical evaluation
    • GP-016 Traceability and identification
    • GP-017 Technical assistance service
    • GP-018 Infrastructure and facilities
    • GP-019 Software validation plan
    • GP-020 QMS Data analysis
    • GP-021 Communications
    • GP-022 Document translation
    • GP-023 Change control management
    • GP-024 Cybersecurity Risk Management
    • GP-025 Usability and Human Factors Engineering
    • GP-027 Corporate Governance
    • GP-028 AI Development
    • GP-029 Software Delivery And Comissioning
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-100 Business Continuity (BCP) and Disaster Recovery plans (DRP)
    • GP-101 Information security
    • GP-200 Remote Data Acquisition in Clinical Investigations
    • GP-026 Market-specific product requirements
    • GP-110 Esquema Nacional de Seguridad
  • Records
  • Legit.Health Plus Version 1.1.0.0
  • Legit.Health Plus Version 1.1.0.1
  • Licenses and accreditations
  • External documentation
  • Public tenders
  • Procedures
  • GP-012 Design, redesign and development
  • Templates
  • T-012-034 Software Test Description

T-012-034 Software Test Description

Change history​

RevisionSummaryDate

Scope​

Instructions

This section describes the scope of the software test, including the software components to be tested, the testing environment, and any limitations or exclusions. It should clearly define what is included in the test and what is not.

Terms and definitions​

TermDefinition

Description​

Instructions

Provide a general description of the software test, including its purpose, objectives, and any relevant background information. This section should give an overview of what the test aims to achieve and why it is necessary

Minimum equipment​

Instructions

List the minimum equipment required to perform the software test. This may include hardware, software and tools.

Preconditions​

Instructions

List any preconditions that must be met before the software test can be performed. This may include specific configurations, data setups, or environmental conditions that need to be in place.

Input data​

Instructions

Describe the input data required for the software test. This should include the format, source, and any specific characteristics of the data that are necessary for the test to be valid.

Steps​

Instructions

Provide a detailed step-by-step description of the software test procedure. Each step should be clear and concise, allowing the tester to follow the process without ambiguity. Include any specific actions, commands, or configurations that need to be performed.

Expected outcome​

Instructions

Describe the expected outcome of the software test. This should include the criteria for success, any specific results that should be observed, and how these results will be measured or evaluated. Be specific about what constitutes a successful test and any thresholds or benchmarks that must be met.

Verifies software requirements​

Instructions

List the software requirements that are verified by this test. Each requirement should be clearly identified, and the relationship between the test and the requirement should be explained. This section ensures traceability and helps in understanding how the test contributes to the overall validation of the software.

Requirement IDDescription

Risk control for​

Instructions

Describe how the software test contributes to risk control. This section should list the specific risks that are addressed by the test ::

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T-012-033 Software Tests Plan
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T-012-035 Software Test Run
  • Change history
  • Scope
  • Terms and definitions
  • Description
  • Minimum equipment
  • Preconditions
  • Input data
  • Steps
  • Expected outcome
  • Verifies software requirements
  • Risk control for
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.)