I want to validate my LabVIEW program.How do I do that?

[RShah]

Hi all,

I am working with a medical implant. I have a LabVIEW program controlling the calibration device for this implant.

As a part of quality system documentation, I need to validate this LabVIEW program. Please help me to understand how do I do that.

Best regards,

Ravi Shah

[Gak]

As your program is used to calibrate a device. After calibration you can check it with equipments like DMM, CRO etc.

There will be some percentage of accuracy required. You can make table of Calibration value from Labview program and Actually Measured value..

[RShah]

Hi Gak,

I think you have misunderstood the question. My LabVIEW program does not calibrate any device. It controls the device which I build to calibrate the implant.Now this LabVIEW program is also considered a part of the quality system and so I need to validate the program. In short for example: If I am controlling a CRO with my LabVIEW program, such as initializing the CRO, reading the data from the CRO,...etc. How do I validate the LabVIEW program itself. I appreciate your reply and hope you can give me some feedback over it.

[Haneef]

Hi,

The calibration can be done as follows

My view (this is how we used to do)

You know what is the output when you provide an input 'x', so provide an input 'x' and measure the output at the hardware (may be DMM or etc) whether the expected value you are able to reach or not.

Or if the functionality of your VI is to read some value, then provide the input from external and verify that whether you are getting the correct waveform or voltage/current/resistance value accordingly.

The best way of calibrating is get a calibrated device and try to control or read the devise using your VI.

Regards

Haneef

[Norbert_B]

Ravi,

i think that you will find the LV Software Engineering Advanced Series quite interesting.

Just to pick a few important points:

- LV itself is not and will not be validated for certain segments (e.g. medical).

- National Instruments as supplier is certified as seen here.

- Validation can only be done for your application. As seen in the first link of this post, we have different LV toolkits helping us to validate LV applications for the specific task. If there are any questions on this, contact your local NI branch for further information.

hope this helps,

Norbert

[RShah]

@ Hannef,

I understand the calibration process. As I mentioned I am looking for a validation process for the LabVIEW program irrespective of what it does. I mentioned about the calibration device just to give an idea about my application.I am looking for some general format of how to validate a LabVIEW program.

@ Norbert

Thank you for the link I think I will get some good information from it. Still if you have any document or any other link where I can find some examples of the validation documents, that would be great.

[Norbert_B]

Ravi,

i am not aware that there are predefined documents for a validation process. I assume that the reason is that validation != validation. It depends on the segment you are in (in your case: medical; others would be mil/aero/...) and the process of the validation itself.

As far as i know, validation can be done by different processes. The only thing all share: they require detailed documentation. Sometimes, the documentation itself is sufficient for the validation.....

So i suggest you to assess this together with the people responsible for the validation. Just make sure to answer the following question:

- What kind of documentation is required? Does it supply templates?

- What else is needed other than documentation?

Regarding the second question, you might end up in the need to name references to other companies working in the medical segment who are working with LV. I think, NI will be interested in helping you here by supplying names of local/global validated companies...

hope this helps,

Norbert

[PhillipBrooks]

See this NI Developer Zone Article:

FDA Validation of Medical Devices with National Instruments Hardware and Software - FAQ

[Steve.J]

Lots of good resources located here too:  http://zone.ni.com/devzone/cda/tut/p/id/7198