Need guidance for Software validation

S

srinu

Starting to get Involved
Dear All,
We developed a software called K-plan ,it's a Knee surgery plan and using MRI data to create the 3D models and made the surgery plan using this software .
Now my question is that to verification and validation for that software what are the requirements to do.
1. Verification is ok
2.For validation what are the things to do to prove that the software is fine.
It's end users are engineers who are working in CAD to create the 3D models.

Please have a look and let mw know any useful data.
 
Last edited by a moderator:
D

DannyK

Trusted Information Resource
Set up a protocol and scenario where you can validate that the calculations performed by the software correspond with the results that you would normally obtain.
 
S

sreekiran14

Involved In Discussions
srinu said:
Dear All,
We developed a software called K-plan ,it's a Knee surgery plan and using MRI data to create the 3D models and made the surgery plan using this software .
Now my question is that to verification and validation for that software what are the requirements to do.
1. Verification is ok
2.For validation what are the things to do to prove that the software is fine.
It's end users are engineers who are working in CAD to create the 3D models.

Please have a look and let mw know any useful data.
Click to expand...

This seems like a software tool to develop a surgery plan and I do not see a direct impact to patient safety. First thing is you need to determine if it is a GxP system or not which lets you understand whether this system needs validation or not. If Yes and if it a custom developed tool then extensive validation is needed. Validation plan, user and functional requirements, functional risk assessment, design specs development and Code review report and followed by qualification protocols and reports before transitioning to production.
 
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