Pre-Trained, Not Pre-Qualified: The QA Risk Behind Third-Party AI Models
Key Takeaways A pre-trained AI model should be treated as a governed AI component, not an invisible technical feature. Pre-trained models should enter through the company’s AI Governance Policy: inventory, ...
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 · GxP Compliance · Inspection Readiness By Ricardo Torres-Rivera, PMP · CEO/President, Xevalics Consulting, LLC Article Summary On April 2, ...
In GxP, If Your Cloud Provider Fails, Can Your Business Keep Running?
Cloud Computing & Cybersecurity · CSV/CSA · GxP Compliance · Inspection Readiness By Ricardo Torres-Rivera, PMP · CEO/President, Xevalics Consulting, LLC Why regulated teams need a new control model for ...
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 Readiness By Ricardo Torres-Rivera, PMP · CEO/President, Xevalics Consulting, LLC Article Summary AI bias is no longer only a clinical-trial, ...
Is Your ELN Audit-Ready or Just Validated? The 6-Risk-Area Control Map for GLP Cutover
Xevalics Insights · GLP · ELN · Inspection Readiness Is Your ELN Audit-Ready or Just Validated? The 6-Risk-Area Control Map for GLP Cutover In GLP environments, ELN audit readiness depends ...
GenAI Is Changing How We Work. Transparency Makes It Work
Why quality, compliance, and CSV leaders need a transparent operating model for AI-assisted work in regulated environments GenAI transparency in professional work matters because regulated organizations still need trust, quality, ...
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 wisely in regulated environments. By Ricardo Torres-Rivera, PMP | Xevalics Consulting, LLC Who This Is For This article is for ...
In GxP, AI Needs Two Proofs: System Qualification and Output Credibility
By Ricardo Torres-Rivera, PMP · CEO/President, Xevalics ConsultingReading time: ~10 minutes - This article explores key considerations surrounding AI validation in GxP. Understanding the growing impact of AI validation in ...
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 one sentence: QMSR inspections are no longer reviewing isolated systems — they are testing whether your entire digital quality ecosystem ...
