Validation of JMP Clinical

Jeff_Upton

We are working with a JMP Clinical customer that operates in an FDA-regulated environment. They posed the following question: can JMP C generate audit trails (or is it 21 CFR Part 11 compliant)?

I found this useful post on Validation of JMP Clinical but couldn't find an explicit answer to the above question.

 

The same customer also had concerns regarding security testing. Another question: was any security testing (penetration testing) performed on JMP C?

I will update the post with what we've found unless someone wants to chime in here!

 

Any/all help would be appreciated!

 

Thanks,

Jeff

Chris_Kirchberg

Hi Jeff,

The question about 21 CFR Part 11 is answered within the Quality Statement of JMP. There is a link to SAS's response which basicall says no and cannot be. It is an exploratory tool and an open system. This applies to all JMP Products.

As far as penetration testings. Please post Geoff and Jeff's response here.

Thanks,