First-of-its-Kind SOP: Responsible Use of AI in GxP Environments

Written By Marco Retzlaff

Artificial Intelligence is transforming the life sciences.
From discovery and clinical trials to manufacturing and quality oversight, AI is already reshaping how we work. But in GxP-regulated environments, adoption must be done responsibly — with the same rigor we apply to any validated system.

To support this transition, Retzlaff Consulting has developed and released the first freely available SOP on the Responsible Use of AI in GxP Environments.

This SOP aligns with global regulatory expectations, including:

  • FDA – Predetermined Change Control Plan (PCCP) for AI-enabled systems

  • EMA – Reflection Paper on AI in the Medicinal Product Lifecycle

  • Health Canada – Good Machine Learning Practice (GLMP, co-signed with FDA/MHRA)

  • WHO – Ethics & Governance of AI in Health

  • ISO/IEC 42001 – Artificial Intelligence Management System standard

What the SOP covers:

  • Risk-based validation and lifecycle management of AI/ML systems

  • Data integrity and ALCOA++ principles for AI-driven processes

  • Governance, accountability, and human oversight

  • Transparency, explainability, and ethical use

  • Practical checklists and a regulatory crosswalk

By making this SOP public, our goal is to help life sciences organizations build AI systems that are innovative, ethical, and inspection-ready.

👉 Download the SOP here: www.retzlaffconsulting.com/ai-gxp-sop

Marco Retzlaff