How do you validate AI features in a GMP system?
The same way you validate any V5 feature: run the approved version, use Enterprise IQ/OQ support, run your own intended-use testing and PQ, and treat AI output as draft-until-signed. Private Cloud customers can defer routine feature releases for up to 180 days after notice to validate them; security fixes and legal requirements can require earlier updates, and longer extensions are agreed in writing.
