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        • R-002-001 Quality objectives list_2023_001
        • R-002-002 Quality objectives_2023_001
        • R-002-002 Quality objectives_2023_002
        • R-002-002 Quality objectives_2023_003
        • R-002-002 Quality objectives_2023_004
        • R-002-002 Quality objectives_2023_005
        • R-002-002 Quality objectives_2023_006
        • R-002-003 Quality indicators_2022_001
        • R-002-003 Quality indicators_2023_001
        • R-002-004 Annual management review report_2023_001
        • R-002-005 Quality Calendar_2023_001
        • R-002-005 Quality Calendar_22_001
        • R-002-006 SWOT and CAME analysis_2023_001
        • R-002-007 Process validation card 2023_013
        • R-002-008 Quality and regulatory roadmap_2023_001
      • R-002-001 Quality objectives list_2024_001
      • R-002-001 Quality objectives list_2025
      • R-002-002 Quality objectives_2024_001
      • R-002-002 Quality objectives_2024_002
      • R-002-002 Quality objectives_2024_003
      • R-002-002 Quality objectives_2024_004
      • R-002-002 Quality objectives_2024_005
      • R-002-002 Quality objectives_2025_001
      • R-002-002 Quality objectives_2025_002
      • R-002-002 Quality objectives_2025_003
      • R-002-002 Quality objectives_2025_004
      • R-002-002 Quality objectives_2025_005
      • R-002-003 Quality indicators_2024
      • R-002-004 Annual management review report
      • R-002-005 Quality Calendar_2025
      • R-002-006 SWOT and CAME analysis
      • R-002-007
      • R-002-008 Quality and regulatory roadmap
      • R-002-009 Regulatory requirements review report
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  • R-002-002 Quality objectives_2023_003

R-002-002 Quality objectives_2023_003

Objective details​

Objective number: 3​

Description​

Complete the transition of the previous QMS system based on Google Drive Workspace, to the QMS Legit.Health, based on Git tool.

Establishment date​

November 2022

Planning​

Responsible​

JD-004

Departments involved​

The main department developing the objective is Quality & Regulatory, although other departments will be notified when required, as the QMS covers all the company areas.

Planned actions for 2023 period​

  1. To complete a gap analysis on the transition activity
  2. To establish a new Quality Calendar to ensure all the process are covered yearly.
  3. To review all the procedures, adapt them to the new QMS and approve them.
  4. To create all the required templates for the different records to be registered according to the implemented procedures.
  5. To record all the activities performed according to the new QMS procedures.

2023_08_17 Update:

One of the requirements that we must comply acccording to the 21 CFR part 11 is to sign the documents by their author, reviewer and approver with a signature that can be verified. We moved the QMS and IFU repositories to GitHub (Microsoft) to implement the required signature procedure through GPG signature tool.

All the documents will be reviewed to adapt their content to the new procedure and to be reviewed and approved by the responsibles accoding to it:

  • Version control table will be deleted as the change control is performed through named commits and the document history by itself.
  • Signature table will be deleted as the signature procedure is performed through GPG key.
  • Signature meaning section will be included to identify each person signature meaning.

Resources needed​

  • Personnel for quality activities performance.

Monitoring and follow up​

Period% CompletionFollow upShort-term actions
December 202220%Gap analysis, Quality Calendar and first 5 General procedures reviewed and updatedCreate corresponding records
Q175%Transition being implemented satisfactory up to dateNot required
Q295%The transition is almost completed: we have reviewed all the procedures, established a new required ones and created the corresponding templates.The quality calendar is working properly and we are performing the different activities accordingly.To improve the signature procedure so it complies with the 21 CFR part 11 regulation.
Q3100%The transition has been completed, including the procedure to sign the documents in compliance with the 21CFR part 11
Q4

Status​

  • [] In progress
  • Completed
  • [] Extended
  • [] Discarded

Record signature meaning​

  • Author: JD-004 María Diez
  • Review and approval: JD-001 Andy Aguilar
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  • Objective details
    • Objective number: 3
    • Description
    • Establishment date
  • Planning
    • Responsible
    • Departments involved
    • Planned actions for 2023 period
    • Resources needed
  • Monitoring and follow up
  • Status
  • 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.)