Software validation in Medical Equipment

#1
I am a new validation manager in medical device ind. who has an extensive experience with IT Software but not with plant manufacturing. I was recently, asked why should we focus on Software validation when our devices are class 1 device and we have process validation in place. If we put materials and get an expected product then why should we waste time in Software validation. I reminded them about the regulatory requirements and its important because software is constantly changing but other than that, i did not have a solid answer.
Any thoughts!
 
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indubioush

Quite Involved in Discussions
#2
Regarding software validation where the software is associated with the equipment, it really depends on the specific software and its intended use. If all software related tasks will be verified through your process validation activities, there is no reason to do a separate validation of the software on its own. The software is validated through your IQ and OQ activities. However, if the output of the software cannot be verified through process validation, you need to validate the software. For example, if you have software that performs calculation activities, which are then compared to some specification, you would want to validate that software to ensure the calculations are really providing the correct output.

I hope this helps. Maybe if you tell us the type of equipment you are talking about, we can help further.
 
Last edited:

yodon

Staff member
Super Moderator
#3
Bear in mind that you can scale your validation efforts commensurate with the associated risk.

I might take a mild exception to @indubioush's statement about the software being validated through IQ and OQ. In many cases, I'd probably agree; but that might be painting with too broad a brush. (It also depends on what is done in IQ.) There may be edge cases in the software than need to be assessed.

And, as noted, software is likely to change (as well as the infrastructure on top of which it runs -both hw and sw) so the controls need to be in place to manage changes and maintain the validated state.
 

yodon

Staff member
Super Moderator
#5
ERP: no question; yes.

When you say "Microsoft," that's a bit broad. Word: no. Specific Excel spreadsheets used in supporting the quality system: yes (validate the spreadsheet, not excel). If you have a specific Microsoft application you're wondering about, please clarify.
 

Adacus

Starting to get Involved
#6
ERP: no question; yes.

When you say "Microsoft," that's a bit broad. Word: no. Specific Excel spreadsheets used in supporting the quality system: yes (validate the spreadsheet, not excel). If you have a specific Microsoft application you're wondering about, please clarify.
Microsoft 365 what about other over the counter software do those neeed to be validated
 

yodon

Staff member
Super Moderator
#7
Always depends on your use. If used to implement the QMS then yes. If used as a typewriter, no. Would have to know specifics on what tools / software you're questioning.
 

Adacus

Starting to get Involved
#8
So if I’m using Microsoft’s office I need to validate it. MRP systems Sage, software called goldmine data of non conforming
 

yodon

Staff member
Super Moderator
#9
So if I’m using Microsoft’s office I need to validate it.
Hmm... not sure how you came to that conclusion. Unless I'm misunderstanding, Microsoft Office is a suite of tools (Word, Excel, Outlook, etc.). As I mentioned in an earlier post, it's most likely that only if you create Excel spreadsheets that implement the QMS, those would need to be validated (not Excel, the spreadsheets themselves).

MRP systems Sage, software called goldmine data of non conforming
Those certainly sound like they're implementing aspects of your quality system so, without knowing how exactly you're using them, I'd say it's highly likely those do need validation.
 
#10
I work on a SaMD (Software as a medical device) company,

We need to have a validation plan for two of softwares used inside de company

  1. our code management software
  2. and complaint tracking software .

I am not sure how deeper my test cases and test verification and validation should be ?

Can you help me and give me some examples ?

Thanks
 
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