R-023-001_008 Change control

Description

• Change name: GP-002 Update - Deprecation of templates T-002-006, T-002-008, T-002-009 and associated records
• Change description: Templates and their associated records have been deprecated from GP-002 Quality Planning procedure:
  1. T-002-006 SWOT and CAME analysis → Deprecated. The SWOT and CAME analysis is now documented directly in the T-002-004 Annual management review report during the Management Review meeting.
  2. T-002-008 Quality and regulatory roadmap → Integrated into T-002-005 Quality Calendar. Now there is a single RA/QA calendar for all planning activities.
  3. T-002-009 Regulatory requirements review report → Eliminated because regulatory requirements are now validated through R-001-005 List of applicable standards and regulations, which is reviewed during the Management Review as described in GP-002 section "Annual review of applicable standards and regulations".
  4. T-002-010 Process risk register → This is a new template that is now managed under the specific procedure SP-002-001 Process risk management.
• Source of change: QMS simplification and alignment with actual practices.

Impact analysis

• Regulatory impact: is the change classified as significant?
  • Yes (it requires notification to Regulatory Authorities)
  • No (it does not require notification to Regulatory Authorities)
• Risk analysis impact: No impact on risk analysis. The underlying activities continue to be performed through consolidated documents.
• Quality documentation impact:
  • GP-002 Quality planning - Update associated documents section
  • Records moved to Deprecated folder:
    • r-002-006-2024-001.mdx (SWOT analysis - last version before integration)
    • r-002-008-2024-001.mdx (Quality and regulatory roadmap - integrated into R-002-005)
    • r-002-009-2024.mdx (Regulatory requirements review - replaced by R-001-005 review)

Approval

• Approved by: JD-004
• Approval date: 2026-02-16

Plan

1. Move deprecated records to Deprecated/ folder in GP-002 records.
2. Update GP-002 associated documents section to remove references to eliminated templates.
3. Ensure R-002-005 Quality Calendar includes regulatory roadmap activities.
4. Verify SP-002-001 manages T-002-010 Process risk register.

Implementation

Implementation date: 2026-02-16

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 Design & Development Manager, JD-004 Quality Manager & PRRC
• Approver: JD-001 General Manager