When is Medical Device Software Validation required?

nicoles6

Starting to get Involved
#1
Hi all,
I work for a company that manufactures components for customers that hold the final device.
What software validation requirements are necessary? Just testing or QMS related equipment?
And can anyone lend a hand as to how to do these validations? None of the individuals on site know much regarding this topic.
Thank you!
Nicole
 
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yodon

Staff member
Super Moderator
#2
That's a pretty broad topic, too much for a simple reply. Any software that is used in the execution of the Quality Management System (whether it be testing software, manufacturing control software, inventory control software, etc.) is subject to validation. You can take a risk-based approach to scope the validation. I generally start with a Master Validation Plan to define my risk levels and document the inventory and (risk-based) validation approaches per software item.

Obviously way more in the details but maybe that gives you an idea. I'd be happy to discuss further if you want to send me an private message.
 

shimonv

Trusted Information Resource
#3
Hi Nicole,
If I understand you correctly - your customer will do the final testing (verification and validation). Since you are a component / sub-system developer you must have a software requirments specification and software detailed design.
In a nutshell, you need to develop test description for each software specification.
After running the tests you produce a test report.

I am sure your customer will review your plans to make sure they get what they asked for. It's important to develop a good working relationship with them; it will help you do a better job.

BR,
Shimon
 
#5
Hi everyone,
Long time lurker first time poster. I do not mean to hijack this thread but i am also on the fence on whether software val is required or process controls would be sufficient.

We are a medical device company (ISO/FDA) and we want to set up online ordering software through our website. Essentially a customer will enter an order creating an invoice which will be emailed to our order entry people.
Our order entry people will then confirm the invoice content with the customer and then transfer the invoice manually into our order management software (which is validated).

Basically the online aspect is to compliment our over the phone ordering.

Any advice would be appreciated, thanks in advance!
 

shimonv

Trusted Information Resource
#6
Hi everyone,
Long time lurker first time poster. I do not mean to hijack this thread but i am also on the fence on whether software val is required or process controls would be sufficient.

We are a medical device company (ISO/FDA) and we want to set up online ordering software through our website. Essentially a customer will enter an order creating an invoice which will be emailed to our order entry people.
Our order entry people will then confirm the invoice content with the customer and then transfer the invoice manually into our order management software (which is validated).

Basically the online aspect is to compliment our over the phone ordering.

Any advice would be appreciated, thanks in advance!
Not sure I fully understand the situation.
From what you are describing, somebody is developing a web tool which does not make the work any easier or more efficient for the organisation. Strange...
If everything is de-facto confirmed over the phone with the customer then it seems the a basic sanity check along with process controls is sufficient. After all, this is a sales tool; not a device or accessory.
I cannot imaging the regulator coming after you about something like that.
Just make sure the process controls are well documented and that no existing SOP about software tools is limiting you in any way.

Shimon
 
#7
Not sure I fully understand the situation.
From what you are describing, somebody is developing a web tool which does not make the work any easier or more efficient for the organisation. Strange...
If everything is de-facto confirmed over the phone with the customer then it seems the a basic sanity check along with process controls is sufficient. After all, this is a sales tool; not a device or accessory.
I cannot imaging the regulator coming after you about something like that.
Just make sure the process controls are well documented and that no existing SOP about software tools is limiting you in any way.

Shimon
Cheers Shimonv, I am thinking along the same lines but am unsure.
 
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