21 CFR Part 11 - Steps to take if we want to validate an electronic system

Anonymous16-2

Starting to get Involved
#1
Hello!

Can anyone help me determine what are my steps to take if we want to validate an electronic system we put together (for inventory, manufacturing, releases, etc) to make it compliant with 21 CFR Part 11?

TIA!
 
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yodon

Staff member
Super Moderator
#3
I'd like to add on a bit to the (excellent) response by @William55401. First, to be clear, validation won't make it compliant; validation can only demonstrate compliance. You can effectively glean the requirements from the regulation and demonstrate compliance as part of validation using the previously-indicated guidance.

It sounds like this is a home-grown system and, to be frank, if the developers didn't consider Part 11 in the design, it's pretty unlikely that you can demonstrate compliance. It's not something you can just bolt on.
 
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