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Rework of non gxp messages #126

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FlavioCampanaBIExt opened this issue Oct 23, 2023 · 0 comments
Open

Rework of non gxp messages #126

FlavioCampanaBIExt opened this issue Oct 23, 2023 · 0 comments
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@FlavioCampanaBIExt
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FlavioCampanaBIExt commented Oct 23, 2023

Changed the way content is printed for non gxp projects, where a different text is printed if an issue is not in a done status:

AGREEMENTS

"Not Mandatory" text logic

  • If a Non-Mandatory Doc Chapter is not on ‘Done status’:
    • ‘Not mandatory.’ text will be printed on the documentation when this results in a totally empty section or sub-section, considering the following exceptions:
      • When there are sub-sections with text/tables potentially printed, then “Not mandatory” is not printed in the main section (example: SSDS – 3.2 SYSTEM DESCRIPTION) = we print nothing
      • Chapters “Abbreviations” and “Definitions” for all documents will print ‘N/A’ text instead of ‘Not mandatory.’
      • Chapter “Reference Documents” for CSD doc that do not print anything, we will print ‘N/A’ text instead of ‘Not mandatory.’
    • ‘Not mandatory.’ text will be not displayed if the outcome is not an empty section, examples:
      CSD – 3.2 OPERATIONAL REQUIREMENTS,
      – DOCUMENT HISTORY,
      [SSDS, CFTP, CFTR, DTP, DTR, IVP, IVR, RA, TIP, TIR, TRC] - REFERENCE DOCUMENTS
  • As a reminder, if a Doc Chapter is on ‘Done’ status, the data located in field “EDP Content” will be displayed in documentation (this Criterion remains the same)
  • We will make sure that document chapters that are not mandatory but recommended are explained in a user guide (examples: SSDS – 9. SYSTEM DATA, SSDS – 3.2 SYSTEM DESCRIPTION, IVR – Op. documents on System Level)

"Reference Documents" section analysis:

  • Docs with empty "Reference Documents" section: CSD.
  • Docs with filled "Reference Documents" section: SSDS, CFTP, CFTR, DTP, DTR, IVP, IVR, RA, TIP, TIR, TRC.
  • Docs with no "Reference Documents" section: TCP, TCR, DIL.

Other topics

On RA – 4.2.1 GXP RELEVANCE subsection, whole field “For | Non-GXP risks are not being evaluated” will be not printed on documentation when we are in context of a Non-Gxp project.

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