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 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.
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
"Reference Documents" section analysis:
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.