FDA

When AI Learns Your Instruments Instead of Your Science: Interoperability, Bias, and the GxP Wake-Up Call

AI/ML Governance · Data Integrity · GxP Compliance · Inspection ...

By Ricardo Torres-Rivera|March 29, 2026|Artificial Intelligence, FDA, Inspections, Model Training, Quality Assurance, Uncategorized|0 Comments

Is Your ELN Audit-Ready or Just Validated? The 6-Risk-Area Control Map for GLP Cutover

Xevalics Insights · GLP · ELN · Inspection Readiness Is ...

By Ricardo Torres-Rivera|March 18, 2026|AI Governance, CSV, Electronic Laboratory Notebooks, ELN, FDA, GLP Compliance, Inspections, Quality Assurance, Regulatory Compliance|0 Comments

In GxP, AI Needs Two Proofs: System Qualification and Output Credibility

By Ricardo Torres-Rivera, PMP · CEO/President, Xevalics ConsultingReading time: ~10 ...

By Ricardo Torres-Rivera|February 21, 2026|AI Governance, CSV, FDA, Quality Assurance, Regulatory Compliance|0 Comments

FDA QMSR Inspections Expose Cross-System Gaps: Why CSV and CSA Now Matter More Than Ever

FDA QMSR Inspection Readiness – Part 2 of 3 In ...

By Ricardo Torres-Rivera|February 15, 2026|CSV, FDA, Inspections, Quality Assurance, Regulatory Compliance|0 Comments

FDA QMSR Is Live: What Changed in FDA Inspections—and What Quality Teams Must Be Ready to Show

Inspection readiness under FDA QMSR is now about system behavior, ...

By Ricardo Torres-Rivera|February 9, 2026|FDA, Inspections, Quality Assurance, Regulatory Compliance|0 Comments

FDA Is Using Agentic AI to Support Inspections: Is This a Game Changer for QA?

What changes for inspection readiness when FDA can cross-check faster—and ...

By Ricardo Torres-Rivera|February 6, 2026|Agentic AI, CSV, FDA, Inspections, Quality Assurance|0 Comments

FDA’s Current Position on Artificial Intelligence in Pharmaceutical Quality (2026)

A practical, inspection-ready translation of FDA’s AI posture for GMP ...

By Ricardo Torres-Rivera|February 3, 2026|Agentic AI, AI Governance, CSV, FDA, Quality Assurance|0 Comments

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