A guide to building AI agents in GxP environments

The regulatory landscape for GxP compliance is evolving to address the unique characteristics of AI. Traditional Computer System Validation (CSV) approaches, often with uniform validation strategies, are being supplemented by Computer Software Assurance (CSA) frameworks that emphasize flexible risk-based validation methods tailored to each system’s actual impact and complexity (FDA latest guidance). In this post, we cover a risk-based implementation, practical implementation considerations across different risk levels, the AWS shared responsibility model for compliance, and concrete examples of risk mitigation strategies.

⚡ AI Revolutionizes Energy Flexibility for a Sustainable Future

AI enhances energy flexibility by optimizing grid planning, forecasting, and operational efficiency, leading to a more resilient power infrastructure. The methods discussed involve machine learning for predictive modeling and real-time data analytics to support sustainable energy management across various regions.

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