Do we need to Validate Off the Shelf Software?

#1
I'm writing a purchasing Work Instruction for a small start up. We use Quickbooks for accounting. Does this software need to be validated?
 
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Ninja

Looking for Reality
Trusted Information Resource
#2
Re: off the shelf software

If you are going to make decisions based on the software calculations...yes.
assuming you are trying to comply with a standard like ISO.

The "validation" for that kind of canned software can be pretty simple: Put in numbers, see the result...do that same function on paper. They match = you've validated it.

HTH
 

mihzago

Trusted Information Resource
#3
Re: off the shelf software

I typically keep software used by accounting, finance, HR, etc., outside of the scope of the QMS, and do not require that the validation is formally documented.

However, companies always validate their software; I don't know anyone that would purchase a software without checking first if it does what they need, and I recommend they at least summarize the activities performed.
 

howste

Thaumaturge
Super Moderator
#4
I'm writing a purchasing Work Instruction for a small start up. We use Quickbooks for accounting. Does this software need to be validated?
I see from your profile that you're working with medical devices. Does this mean you need to conform to ISO 13485, 21 CFR Part 820, CMDCAS, European MDD, etc.? More information will help you to get the right answer to your question.
 

Ajit Basrur

Staff member
Admin
#6
I'm writing a purchasing Work Instruction for a small start up. We use Quickbooks for accounting. Does this software need to be validated?
Typically accounting software is outside the scope of QMS certification. However if this software is aiding the organization in inventory management, it should be validated.
 
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