FDA's AI Guidance: 7-Step Credibility Framework Explained
Learn about the FDA's AI guidance for drug development. This article explains the 7-step credibility framework, context of use (COU), and risk-based approach.
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Articles tagged with “risk-based-approach”
A GAMP 5 Guide to AI/ML Validation in GxP Environments
Learn to apply the GAMP 5 risk-based approach for AI/ML validation in GxP environments. This guide covers data integrity, model drift, and regulatory compliance
GAMP 5 Categories Explained: Software, Risk & Examples
Learn the GAMP 5 software categories for computerized system validation. This guide explains each category with examples and its role in a risk-based approach.
Understanding GAMP 5 Guidelines for System Validation
An overview of GAMP 5 guidelines for validating computerized systems. Explains the risk-based approach, system lifecycle, and updates for AI and cloud tech.
GAMP 5: Computerized System Validation in Pharma
This guide explains GAMP 5, its principles, and lifecycle for computerized system validation in pharma, covering regulatory compliance and real-world applications.