Software Validation for FFS Packaging Machine

[HnZul]

Hi Everyone!

Its a startup medical device company and we have established our own manufacturing. We are going to have a FFS packaging machine in our production floor. The issue is how do we able to know to what extend we require to do a software validation for the packaging machine. Is the software validation certificate from the manufacturer sufficient for us? do we really need to come out with protocol and do the software validation as per ISO 13485:2016. if there is anyone who able to share with us any example or template it is greatly appreciated.


Thanks in advance!

 

[yodon]

A bit short on information to give much guidance here. Such validations should be commensurate with the risk. What are the risks (in terms of risk to patients / users, environment or regulatory compliance) if the software fails? Then, what are the requirements for the software for your intended use? And don't just consider functional; consider aspects like security and, if applicable, Part 11.

I would expect that this is not your only software application that should be validated. You should probably consider establishing a Master Validation Plan to establish the basis for your risk-based approach.