Medical Device Process validation, Validation of excel spreadsheets used for process

#1
Hi

I have been trying to figure out the depths i should delve into excel spreadsheet validation.

I want to know if I should be validating the excel spreadsheets that we used to conduct process validation.
This seems like a never ending exercise, however the risk to process and design validation if these spreadsheets are not validated is of course very high.

Any thoughts or advice would be amazing.

Matt
 

Pads38

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#2
Re: Medical Device- Process validation, Validation of excel spreadsheets used for pro

Hi Matt,

Welcome to the forums.

I recall that we had a previous discussion on spreadsheet validation, here:-
Software Validation – Clause 4.1.6 of ISO 13485:2016

That thread has a bunch of links to informative sites.
And the clear consensus that you do not have to validate the underlying software - it is your functions / macros / formulae that require validation.
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#3
Re: Medical Device- Process validation, Validation of excel spreadsheets used for pro

Please note that the validation of the excel spreadsheets is an application of software validation inside the process validation. See, for example, IEC 80002-2, which includes examples.
 
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