Good afternoon all,

I was wondering if anyone would be able to help - we recently had an audit from one of our customers. One non-conformity they raised was we were using an unvalidated spreadsheet.

This spreadsheet is used for recording test results and report numbers, no calculations are involved, no macros are used, the only restrictions are based upon the user access to the folder in which the spreadsheet is kept.

What strategy would you use for "validating" the use of such a spreadsheet?

I was going down the lines of developing a combined User Requirements Spec / Functional Spec with the spreadsheet structure etc, but what sort of functional testing can I do with a simple spreadhseet like this?

Yours confusedly,

Achorste

Coincidentally I received this link to an on-line (http://www.complianceonline.com/ecommerce/control/trainingFocus?product_id=701327&channel=mailer=Alfonso_AUG-11_AUG-10_EM) seminar concerning this very subject this morning and I was thinking of attending to find out the same thing - How do you validate a simple non-calculating spreadsheet? I have no idea if the course is any good, but I have attended a couple of their sessions before and found them to be pretty good value.

If you don't get the answer you need from the Cove maybe it is worth the £249 fee, although the session is tomorrow so probably a bit late! NB I am in no way affiliated with Compliance Online.

Regards,

Jimmy

I think about all you can do is show that the user restrictions are properly implemented. You should probably also show how the data is immutable, once entered (or if you can't go that far, show rationale for whatever protections that are in place are sufficient).

Hi! Was the non-conformance concern about the integrity of the data entered? If so, the only way to increase the chance of catching an error such as transposition (entering numbers or data 'backwards') is to deploy multiple visual inspections and/or to institute a reasonable High and Low limit for the cell values. :cool:

Have a look HERE (http://www.spreadsheetvalidation.com/companyinfo/articlesindex.htm)

Complianceonline is going to conduct a live online training on “Validation and use of Excel spreadsheets in FDA regulated environments”. The training date is scheduled on August 11, Tuesday at 10:00 AM PDT. For more information refer here (http://www.complianceonline.com/ecommerce/control/trainingFocus?product_id=701327&channel=mailer=Alfonso_AUG-11_AUG-11_DM)

I had an ex-FDA investigator tell me she didn't care about the use of a spreadsheet if it didn't perform any calculation, so in your case, I would concern my validation around access and audit trails if the data is a part of your quality records.

http://www.ofzenandcomputing.com/zanswers/609

Hi Achorste,

If the spread sheet is not involved in any calculation, then it can be considered as a document. And if it is involved in the any official trade, the security access is to be validated. We can test the following;

1) Configuration of the base system,
2) Data source
3) Security of the data and the user
4) Application software specification
5) Functionality of the application software

By testing these parameters, we can declare that the data and functionality has been validated.

Document Methodology:
1) URS preparation
2) Validation Plan
3) Validation test scripts
4) Reporting
5) Testing the URS compliance

Regards / Raghu

Thank you all for your help, I'm putting a generic protocol for spreadsheet validation together now - I will try to remember to post it up if anyone's interested :D

Thanks again.

Thank you all for your help, I'm putting a generic protocol for spreadsheet validation together now - I will try to remember to post it up if anyone's interested :D

Thanks again.

We are interested :)

I have only some experience with excel and one of the problem I have seen about non calculating sheet is the input format
if You insert special characher like ^ @ or something that looks like a date and press enter the cell is formatted. You can go back and edit the results but it may happen You have not corrected the format. The worst case is: if You enter @+something, then You You go back to the cell and overwrite a number, You will see the number but for excel is a string!
I have seen an excel spreadsheet at one of my customer (pharmaceutical) and it was protected against any special characheter, invalid date format (only DD/MM/AAAA was allowed), invalid entry (if is required a number only a number can be written) etc.

This spreadsheet is used for recording test results and report numbers, no calculations are involved, no macros are used, the only restrictions are based upon the user access to the folder in which the spreadsheet is kept.

What strategy would you use for "validating" the use of such a spreadsheet?


one way we get around validation of non-calculating spreadsheets (or word docs, or pdfs for that matter) is to print out the file and sign it. then we can argue that 100% verification is being performed.

I have remembered that someone once addressed me to http://www.npl.co.uk (http://www.npl.co.uk/)
Under http://resource.npl.co.uk/docs/science_technology/scientific_computing/ssfm/documents/ssfmbpg7.pdf You can find some useful informations

I have remembered that someone once addressed me to http://www.npl.co.uk (http://www.npl.co.uk/)
Under http://resource.npl.co.uk/docs/science_technology/scientific_computing/ssfm/documents/ssfmbpg7.pdf You can find some useful informations

Nice find - that's going straight in my reference docs folder!

Am I the only sad one here who has a folder on his PC crammed with virtually every guidance doc / open standard / sample doc etc he comes across? It's all useful at some point :D