Training material for interpretation & understanding Part 11 requirements

[Aphel]

Hello!

Has someone training material regarding FDA part 11 requirements available, which are useful for interpretation and understanding the requirements out of part 11?

Thanks a lot in advance for any feedback!

BR
Aphel

 

[Mark Meer]

Don't have anything for you at the moment, but I'm curious: what is the need for additional training?

Granted, there are a few lines in Part 11 that perhaps warrant discussion & interpretation, but overall the regulation is pretty straight forward and comprehensive.

Are there particular line-items that are unclear to you?

 

[Aphel]

Hello.

Thanks for the response.
I have ongoing discussions - from understanding it is not possible the define a single software tool (e.g. clean room monitoring tool) as part 11 complaint - without considering the appropriate IT hardware... am I right?

BR
Aphel