Articles tagged with “fda-csa”

Validating AI in GxP: GAMP 5 & Risk-Based Guide

Learn AI/ML validation in GxP using GAMP 5 2nd Ed. and FDA CSA. Explains risk-based lifecycles, data integrity, and compliance for adaptive models.

45 min read

2/2/2026

ai validation gxp compliance gamp 5 machine learning fda csa data integrity computer system validation eu annex 11 risk management

IEC 62304 vs FDA CSA: A Medical Software Compliance Guide

Compare the IEC 62304 standard vs. FDA CSA guidance for medical software. Learn key differences in scope, risk classification, validation, and documentation.

35 min read

12/28/2025

iec 62304 fda csa medical device software software validation 21 cfr 820 qms software regulatory compliance iso 13485