Does anyone use AAMI TIR36, validation of software for regulated processes?
Is it recognized by FDA? How
I’ve never used it. GAMP V is typically the “how to” when trying to meet CFR Part 11 compliance (software/computer). ISPE has a good set of books for this.
I think the AAMI TIR36 has some good practical consideration and examples. Also the draft “ISO/PRF TR 80002-2 Medical device software – Part 2: Validation of software for medical device quality systems” is based on the AAMI TIR36.
Graham, you also have some training videos on software validation. That is another good high level resource.