AI System Validation

The growing use of AI-based tools and machine learning models in GxP-regulated environments introduces new validation considerations and challenges. We take a comprehensive approach to AI compliance, ensuring not only that AI systems are reliable, well-documented, and aligned with regulatory expectations, but also that the entire AI development lifecycle is governed by appropriate policies, procedures, and controls.

• AI/ML Model Validation Frameworks – Establishing structured validation and assurance approaches to ensure AI-driven systems function as intended and meet regulatory expectations.

• Risk-Based Validation Approaches – Assessing AI models based on impact, data integrity, and regulatory risk.

• Data Integrity & Bias Assessments – Ensuring AI models produce consistent, reproducible, and unbiased results.

• Compliance & Audit Readiness – Aligning AI validation practices with industry best practices, GAMP guidelines, and regulatory requirements.

By integrating AI validation into your overall compliance framework, we help ensure your AI-driven systems meet regulatory expectations while maintaining transparency and control.