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QMSQMS
QMS
  • 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-012-001 Requirements
        • T-012-003 Test run
        • 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-012-014 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-012-018 Test plan
        • T-012-019 SOUP
      • 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
    • GP-025 Corporate Governance
    • 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
  • Records
  • TF_Legit.Health_Plus
  • Licenses and accreditations
  • External documentation
  • Procedures
  • Records
  • Procedures
  • GP-012 Design, Redesign and Development
  • Templates
  • T-012-004 Software version release

T-012-004 Software version release

Software version​

  • Software version to be released: Version R.X.Y.Z
  • Previous software version: Version R.X.Y.Z

Requirements​

All the requirements associated with this software version release are approved and stored in the DHF folder Version R.X.Y.Z.

The approved requirements that have been reviewed as part of this software release are:

Instructions

Insert the requirements ID and name (e.g. REQ_001 The user receives quantifiable data on the intensity of clinical signs) together with their versions (commit in GitHub) and date of approval.

Requirements verification​

All the test runs associated with this software version release successfully passed, are approved and stored in the DHF folder Version R.X.Y.Z.

The approved test runs that have been reviewed as part of this software release are:

Instructions

Insert the test runs ID and name (e.g. TEST_001 The user receives quantifiable data on the intensity of clinical signs) together with their versions (commit in GitHub) and date of approval.

Software technical specifications​

Instructions

Insert the procedure and environment used to create this software version or make reference to the applicable documents where this information is available (e.g. R-TF-012-006 Lifecycle plan and report).

Additionally, the table below lists the specific versions (or commits) of the microservices that comprise this system-level version of the medical device:

Microservice nameCode repositoryVersion (or commit)

Known residual anomalies​

Instructions

Insert the list of known residual anomalies (if any) and a conclusion about their evaluation in terms of risks. If there are not any residual anomalies, insert a statement about absence of residual anomalies.

Final checklist​

After reviewing the evidence defined by the company’s Quality Management System, I (JD-005) can verify the following checks:

  • All the identified risks have been evaluated, addressed and reduced as far as possible.
  • Design control traceability is well-documented and maintained as part of the technical documentation.
  • The Technical Documentation is up to date.
  • All the verification and validation activities have been perfomed according to established plans and successfully passed.
  • Label is correctly applied, including CE marking.
  • The medical device complies with all the applicable regulatory and legislative requirements set out in MDR 2017/745 and any other applicable regulations and standards as specified in the technical documentation.
  • The medical device has obtained the required regulatory approval (CE mark certificate)
  • If the software release includes significant change, Notified Body has been informed.

Technical manager statement​

Instructions

Insert conclusion about the software version release.

Record signature meaning​

  • Approver: JD-005
Delete this

Delete this section when you create a new record from this template.

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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T-012-003 Test run
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T-012-005 Design change control
  • Software version
  • Requirements
  • Requirements verification
  • Software technical specifications
  • Known residual anomalies
  • Final checklist
  • Technical manager statement
  • Record signature meaning
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.)