Validation of software used for product realisation

J

JeromeL

#1
Hi all,

I work for a patient-specific medical device manufacturer, and we are using a few software tools that were developed in-house for our product realization.

For instance, we have developped a web-based interface to enable doctors to send us the appropriate patient data for each work order.

Also, we have developped "macros" for our CAD software in order to save valuable production time.

Our quality consultant claims that for each software tool, we need to validate the code line by line, using thorough methods. It honestly looked more complicated than the coding itself.

My feeling, based on everything I have read so far, is that when a process' output is entirely measurable, it is sufficient to demonstrate that it matches the requirements specified as the input, and the process itself doesn't need to be directly validated.

For our web file transfer interface, we could use a significant sample of test cases to demonstrate the transfer occurs the way it should.

For our CAD software (3rd party, well-known) macros, we can easily make virtual measurements on the CAD part, make real measurements on the milled part, and also test it for fit on standard parts to demonstrate the input requirements are met.

Would anybody have suggestions on the matter, or online references, guidelines, etc. I could look up?

Thanks!
 
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Gert Sorensen

Forum Moderator
Moderator
#3
Hi all,

I work for a patient-specific medical device manufacturer, and we are using a few software tools that were developed in-house for our product realization.

For instance, we have developped a web-based interface to enable doctors to send us the appropriate patient data for each work order.

Also, we have developped "macros" for our CAD software in order to save valuable production time.

Our quality consultant claims that for each software tool, we need to validate the code line by line, using thorough methods. It honestly looked more complicated than the coding itself.

My feeling, based on everything I have read so far, is that when a process' output is entirely measurable, it is sufficient to demonstrate that it matches the requirements specified as the input, and the process itself doesn't need to be directly validated.

For our web file transfer interface, we could use a significant sample of test cases to demonstrate the transfer occurs the way it should.

For our CAD software (3rd party, well-known) macros, we can easily make virtual measurements on the CAD part, make real measurements on the milled part, and also test it for fit on standard parts to demonstrate the input requirements are met.

Would anybody have suggestions on the matter, or online references, guidelines, etc. I could look up?

Thanks!
All software used for production, and documentation is required to be validated. Macros need to be validated more thorough, because they are not a part of the OTS software (which also needs to be validated). Web interface for patient data transfer needs to be validated and it needs to adhere to regulation regarding patient data safety.

The thing about software is that it is much harder to control the actual result and actions of it, than it is for a process. Therefore the focus is on validation, documentation, and built-in checks and balances.

Depending on your product and your markets you may need to look various places for the legislation (you may need a lawyer to help you with that). Besides that, FDA's guideline for software validation is a good starting point.
 
W

wrodnigg

#4
For medical devices there is the standard AAMI TIR36:2007:
Validation of software for regulated processes

Abstract:
Applies to any software used to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, and complaint handling or to automate any other aspect of the quality system as defined by the Quality System Regulation (21 CFR 820). In addition, it applies to software used to create, modify, and maintain electronic records and to manage electronic signatures that are subject to the validation requirements (21 CFR 11). This TIR can also be broadly applied wherever software automates processes regulated by the FDA.
This TIR applies to software used in the production of a device and to software used in implementation of the device manufacturer?s quality system. It does not apply to software used as a component, part, or accessory of a medical device or software that is itself a medical device.
You can find a preview here.
 

yodon

Staff member
Super Moderator
#5
For our web file transfer interface, we could use a significant sample of test cases to demonstrate the transfer occurs the way it should.
Just to add on to the excellent advice so far, the above caught my eye.

This would be, IMO, demonstrating what we call "happy path." It all works quite nicely if everything is perfect. It's often when you venture off the happy path that you get into trouble. Part of validation should include some level of robustness testing, error checking, etc. Since it's a web interface, you also need to consider the likelihood of data transmission errors. Hopefully you have things like checksums built in to avoid that but if not, then you need to consider the event.

The statement about validating the code line by line is quite bogus. You DO need to validate (as the others have indicated) and it does need to be thorough (as your consultant mentioned) but the method(s) are up to you. They should be well-planned in a Validation Plan document which should describe how you will (thoroughly) validate.
 
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