Regulatory Open Forum

Hello Experts,

We do use SW to create 3D models and drawings.
Could you please explain, how we can do validation of SW?
Please give me some tips and tell me easiest method

Thanks 

Hi,

The first question would be what is the intended use of the software? What are these 3D models used for, a surgical setting?

To validate software you must first establish requirements by defining the intended use, functionality, and performance requirements the software needs to meet for your specific applications and workflows. Then you need to establish from those Software requirements or  SRS a series of tests that you can conduct to validate the operation of the software and its functionalities, especially the potentially risky functions. Then every time there is a software update you update the test with the new features and then re-run the whole validation.

Hope that helps, if you have more questions feel free to contact me.

Hello Experts,

We do use SW to create 3D models and drawings.
Could you please explain, how we can do validation of SW?
Please give me some tips and tell me easiest method

Thanks 

Hi,

The first question would be what is the intended use of the software? What are these 3D models used for, a surgical setting?

To validate software you must first establish requirements by defining the intended use, functionality, and performance requirements the software needs to meet for your specific applications and workflows. Then you need to establish from those Software requirements or  SRS a series of tests that you can conduct to validate the operation of the software and its functionalities, especially the potentially risky functions. Then every time there is a software update you update the test with the new features and then re-run the whole validation.

Hope that helps, if you have more questions feel free to contact me.

Hello Experts,

We do use SW to create 3D models and drawings.
Could you please explain, how we can do validation of SW?
Please give me some tips and tell me easiest method

Thanks 

Hello Seb, 

Thanks for your response. How we should define intended use, functionality, and performance specifications?

Should we define in our risk management file or seprate document for SW validation?
I'd prefer to keep it as a separate document.

Do you have generic template for Computer systems validation, etc?

Hi,

The first question would be what is the intended use of the software? What are these 3D models used for, a surgical setting?

To validate software you must first establish requirements by defining the intended use, functionality, and performance requirements the software needs to meet for your specific applications and workflows. Then you need to establish from those Software requirements or  SRS a series of tests that you can conduct to validate the operation of the software and its functionalities, especially the potentially risky functions. Then every time there is a software update you update the test with the new features and then re-run the whole validation.

Hope that helps, if you have more questions feel free to contact me.

Hello Experts,

We do use SW to create 3D models and drawings.
Could you please explain, how we can do validation of SW?
Please give me some tips and tell me easiest method

Thanks