Quality Assurance

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

In GxP, If Your Cloud Provider Fails, Can Your Business Keep Running?

Cloud Computing & Cybersecurity · CSV/CSA · GxP Compliance · ...

By Ricardo Torres-Rivera|April 1, 2026|Cloud Computing, CSA, CSV, Inspections, Quality Assurance|0 Comments

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

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 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

“EPA Inspectors Don’t Ask for Validation Documentation.” Why Do It Anyway?

The GLP Answer: Data Integrity (and why “software verification” alone ...

By Ricardo Torres-Rivera|February 12, 2026|CSV, GLP Compliance, Inspections, Quality Assurance, Regulatory Compliance, Uncategorized|0 Comments

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