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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
    • GP-001 Documents and records control
    • GP-002 Quality planning
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 HR and training
    • GP-007 Post-market surveillance
    • GP-009 Sales
    • GP-010 Suppliers
    • GP-012 Design, Redesign and Development
    • GP-018 Infrastructure and facilities
    • GP-019 Software validation
      • 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
      • R-019-002 External software list
    • GP-023 Change control management
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-200 Remote Data Acquisition in Clinical Investigations
  • TF_Legit.Health_Plus
  • Licenses and accreditations
  • External documentation
  • Records
  • GP-019 Software validation
  • R-019-001 Software validation report_HubSpot_2024

R-019-001 Software validation report_HubSpot_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​

HubSpot

Manufacturer​

HubSpot, Inc.

Intended use​

The intended use of Hubspot is to have a controlled system to collect and manage all the customers communications, including customers complaints.

Risk-based analysis​

The software is used as a controlled system to register the customers complaints. Its failure to perform as intended should not result in a quality problem that foreseeably leads to compromised safety, as we have established a process to manage and follow up with complaints, including the notification of any accident or incident to the National Competent Authorities. As such, the software does not pose a high process risk.

Requirements and design specification​

Requirement 01: Users provide the information specified at the GP-014 Feedback and complaints procedure to record if the communication corresponds to a complaint, and the steps to follow.

Assurance activities and test plan​

In addition to the tests and checks designed to ensure the configuration complies with the established requirements, we have performed an assessment of the system capability (see R-002-007 Process validation card 2023_002) and a supplier evaluation (see R-010-001 Suppliers evaluation).

IDTest descriptionAcceptance criteriaRequirement tested
Test 01Verification that the users can provide all the information required at the GP-014 Feedback and complaints prodedureThe template is correctRequirement 01

Test Results and deviations detected​

Test 01​

  • Result: Pass
  • Deviation: No deviations found

evidence of complaint

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 observed in the fields destined for filling the required information. Incorrectly inputting text into the fields is immediately visible and does not impact the safety of the device.

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
  • Risk-based analysis
  • Requirements and design specification
  • Assurance activities and test plan
  • Test Results and deviations detected
    • Test 01
  • 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.)