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Do we need to Validate Off the Shelf Software?

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off the shelf (ots) equipment or parts or software, purchasing, small companies (small businesses), software (off the shelf), software validation, validation (general), work instructions (wi)
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  Post Number #1  
Old 15th March 2017, 09:01 AM
ccurran

 
 
Total Posts: 2
Question Do we need to Validate Off the Shelf Software?

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

Last edited by Sidney Vianna; 15th March 2017 at 11:37 AM. Reason: title descriptor improved

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  Post Number #2  
Old 15th March 2017, 09:40 AM
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Ninja

 
 
Total Posts: 1,088
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
Thank You to Ninja for your informative Post and/or Attachment!
  Post Number #3  
Old 15th March 2017, 09:50 AM
mihzago

 
 
Total Posts: 201
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.
Thanks to mihzago for your informative Post and/or Attachment!
  Post Number #4  
Old 16th March 2017, 01:08 PM
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howste

 
 
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Re: Do we need to Validate Off the Shelf Software?

Quote:
In Reply to Parent Post by ccurran View Post

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.
  Post Number #5  
Old 16th March 2017, 01:12 PM
ccurran

 
 
Total Posts: 2
Re: Do we need to Validate Off the Shelf Software?

Thanks for all of the help. We are planning to be certified to ISO 13485:2016.
  Post Number #6  
Old 16th March 2017, 07:56 PM
Ajit Basrur's Avatar
Ajit Basrur

 
 
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Re: Do we need to Validate Off the Shelf Software?

Quote:
In Reply to Parent Post by ccurran View Post

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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