Cat 3 & cat 4 spreadsheets... when is URS? FS? DS?

COMPUTER SYSTEM VALIDATION (CSV) SOFTWARE VALIDATION DOCUMENTATION
1

Hi,

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!

2

In terms of GAMP categories I would use the following:

Cat 3:

  • MS Word
  • Excel
  • Minitab

Cat 4:

  • Trackwise’s document management application (configuration)
  • Pilgrim Software’s enterprise management suite (configuration
  • LIMS
  • Excel with modules

Cat 5:

  • Camstar’s MES solution (configuration and programming)
  • SAP (configuration and programming)

Most custom build devices used in the Medical Device industry
In my opinion Excel sheets simple of complex should fall into category 3 and 4

I would not allow just a URS to be developed for a simple URS, what does this prove?

What does this simple spreadsheet actually do?

I always perform a small system validation for all spreadsheets and do a combined URS/FS/IQ/OQ/RTM.

Simple of complex I would use the same template structure, obviously the complex spreadsheet will require more
testing.

Regards

3

Also check out this post:

http://www.askaboutvalidation.com/forum/showthread.php?t=15

4

What I call a simple spreadsheet (cat 3) would be a spreadsheet performing calculations with simple Excel functions (e.g. standard deviation, average, etc.) while I consider a more complex spreadsheet (cat4) something that will involve macro’s. So you seem to agree that FS must be done both for cat 3 and 4… what about Design specifications?

For the way the documents will be divided, I am planning on having :

  • one VP for both categories
  • one combined URS/FS/DS for each category
  • one combined IQ/OQ for each category
  • one single PQ for both category —> in this document, I will just test that all spreadsheet work all together as a system. That means that I will just test the links and data transfer between the spreadsheets (the stand-alone functionalities would have already been tested in OQ and for spreadsheets that remain stand-alone in the system, PQ will be equal to OQ)

Does this seem to make sense?

Thank you again for your answer!

5

Yes, I think this seems like a logical approach and a good stratedgy.

Make sure that you mention in the Validation Plan that you are using the PQ as a method to test the integration between both systems.

Best of luck!

6

Thanks for your answers!