I am validating now some spreadsheets and when doing the GAMP categorization, I have :
- cat 3 for simple spreadsheets not involved in data transfer
- cat 4 for spreadsheets with macros and involved in data transfer
Following the GAMP, for cat 3, we need to provide only a URS, while for cat 4, we need the whole thing (URS, FS, TDS).
But I am wondering how it is possible for cat 3 to produce only a URS and proceed for the IQ and OQ because for me :
FS is also necessary since that is where we will detail for instance the formula’s which need to be included in the sheet
TDS is also necessary since it gives a view on the designe specs (data input/output in one specific color, cells in a specific format etc.)
My question would then be to know if the way I am thinking is correct on this and therefore why are FS and TDS not foreseen for spreadsheets cat 3.
Thanks already for your answers!