AI Governance

Pre-Trained, Not Pre-Qualified: The QA Risk Behind Third-Party AI Models

Key Takeaways A pre-trained AI model should be treated as ...

By Ricardo Torres-Rivera|June 17, 2026|AI Governance, Cloud Computing, CSV, FDA Warning Letters, Inspections, Quality Assurance|0 Comments

When AI Missed Process Validation — and QA Didn’t Catch It: Lessons from FDA’s First AI Warning Letter

Generative AI · QA Literacy · AI Governance · CSV/CSA ...

By Ricardo Torres-Rivera|April 21, 2026|AI Governance, Artificial Intelligence, CSV, FDA Warning Letters, Inspections, Quality Assurance, Regulatory Compliance|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

GenAI Is Changing How We Work. Transparency Makes It Work

Why quality, compliance, and CSV leaders need a transparent operating ...

By Ricardo Torres-Rivera|March 15, 2026|AI Governance, CSV, GenAI, Quality Assurance, Regulatory Compliance|0 Comments

Generative AI Is Rewriting Computer System Validation — Here Is What Changes and What Never Will

The era of GenAI-aided CSV is here. Accelerate boldly. Govern ...

By Ricardo Torres-Rivera|February 24, 2026|AI Governance, CSV, GenAI, 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’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

Agentic AI in GLP Lab Automation: Faster Studies, Audit-Ready by Design

Implications for OECD/FDA/EPA GLP, 21 CFR Part 11, Data Integrity, ...

By Ricardo Torres-Rivera|January 28, 2026|Agentic AI, AI Governance, CSV, GLP Compliance|0 Comments

Agentic AI, Global Governance, and Regulatory Compliance

Agentic AI, Global Governance, and Regulatory Compliance Implications for CSV ...

By Ricardo Torres-Rivera|January 21, 2026|AI Governance, CSV, Regulatory Compliance|0 Comments

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