Risk Assessment for Excel Spreadsheets

Hello,

Can anybody give me examples of RA for simple Excel spreadsheets (no macros)?
I’m in the middle of writing SOP for this topic and I’d like it to be as simple as possible. I have no experience in this area.

Thanks in advance.

[quote=valtschaq]Hello,

Can anybody give me examples of RA for simple Excel spreadsheets (no macros)?
I’m in the middle of writing SOP for this topic and I’d like it to be as simple as possible. I have no experience in this area.

Thanks in advance.[/quote]

Hello.

I first like to point out if you do not know about the topic you should not be writing the SOP. The SOP should be written by the subject matter expert.

Secondly, for starters, here are two examples: what if a calculation is wrong, what if someone has editable access that should not. The RA is going to be unique for each spreadsheet so don’t get caught up in trying to detail everything in an SOP. Remember the SOP is suppose to be a general document to guide you have to do it, the protocol is the detailed document explaining who what when where how and why.

[quote]Hello.

I first like to point out if you do not know about the topic you should not be writing the SOP. The SOP should be written by the subject matter expert.[/quote]

Yes, I know that. But we have no expert in this subject.

Yes, I understand the general idea of RA and writing SOP’s. What I meant was to show me which method should I use:

  1. to define which spreadsheet is critical
  2. to define which function of the spreadsheet should I test.

Thank you for your advice.

i would also be interested in this advice as i have been given a similar task to risk assess if validation is required for spreadsheets in use. Thanks

Refer to GAMP 5.
It is crystal clear on this topic. Thanks.

Criticality is got by answering the question “what quality decision depends on this info?” it is unique to each worksheet.
Also remember you are not validating the formuae used such as “=SUM(A1:A3)”. these are standard.
rather you are checking your implementation of the standard formulae. i.e. combinations such as “=IF(A1=”",SUM(A2:A4),SUM(B2,B4))" so the more complex, the more testing you do. esp where using Lookup formulae and IFF.