SOP on the Responsible Use of AI in GxP Environments
Turning regulatory expectations into operational Good AI Practice.
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Artificial Intelligence and Machine Learning (AI/ML) are reshaping how life sciences companies operate. From clinical data analysis to GMP manufacturing, regulators now expect AI to be managed with the same rigor as any other GxP system. To help organizations navigate this new landscape, Retzlaff Consulting has developed the first SOP on AI in GxP-regulated environments, aligning with FDA, EMA, Health Canada, PIC/S, and WHO guidance.
What you’ll get in this SOP:
Clear requirements for AI/ML system validation and lifecycle control
Integration of ALCOA++ data integrity principles
Guidance on transparency, explainability, and model updates (PCCPs)
Regulatory crosswalk to FDA, EMA, Health Canada, WHO frameworks
Practical controls for ethics, bias, and data protection
Value:
✅ Aligns with global regulators — EMA/ FDA guidance and Reflection Paper, ISO 42001:2023, ICH, PIC/S, Health Canada GMP Guide, and WHO AI ethics principles.
✅ Operationalizes GxP compliance for AI/ML — validation, documentation, and lifecycle controls tailored to regulated environments.
✅ Strengthens data integrity — integrates ALCOA++ principles into AI-enabled systems and processes.
✅ Manages AI risks proactively — bias, explainability, re-training drift, and human-in-the-loop oversight.
✅ Accelerates innovation responsibly — enabling faster adoption of AI while remaining inspection-ready.
Why download this SOP?
Stay ahead of FDA and EMA guidance on AI in drug development and manufacturing.
Ensure inspection readiness for AI-enabled systems.
Translate broad regulatory principles into concrete operational requirements.