Expert analysis on AI governance, regulation, and responsible AI deployment for regulated industries.
In-depth analysis on the topics that matter most to regulated organizations navigating AI governance — from EU AI Act timelines to FDA expectations for AI systems. Subscribe below to be notified when new articles are published.
AIMS in a GxP context means an AI management system under ISO/IEC 42001. Here's how it fits alongside GAMP 5 and ICH Q9(R1) — the frameworks it actually integrates with.
A clause-by-clause guide to where AI systems create Part 11 risk in validation, audit trails, and signatures — with the FDA guidance that actually addresses it.
AI Annex 11 explained: what EU GMP Annex 11 requires from AI systems today, how draft Annex 22 will change it, and what to do before it's final.
How to validate AI-enabled systems in GxP environments under GAMP 5, FDA's CSA guidance, and ISO 42001. A practical framework from Certify Consulting.
A practical guide to applying FDA's Computer Software Assurance logic to AI in pharma GxP systems, with a risk tier table, worked example, and documentation checklist.
How ALCOA+ and 21 CFR Part 11 apply when AI touches GxP data, with a practical framework for building an AI data integrity program.
A practitioner's guide to AI GMP compliance: where AI touches cGMP operations, what FDA and EU regulators expect, and how to validate it.
A practical guide to building an AI management system for pharma, mapped to ISO 42001, FDA guidance, and Part 11. Get the framework right the first time.
How pharmaceutical companies extend ICH Q10 quality systems to govern AI under GxP, FDA guidance, and ISO 42001. A practical build guide.
How to validate AI in GxP environments under FDA, GAMP 5, Annex 11, and ISO 42001 — a risk-based framework you can actually implement.
EU AI Act medical device rules explained: the Article 6(1) trigger, the Aug 2, 2027 deadline, and how to fold Chapter III into your MDR/IVDR file.
A clause-level guide to the EU AI Act for pharma AI: risk tiers, MDR overlap, deadlines, ISO 42001 alignment. Talk to Certify Consulting.
A practitioner's map of FDA AI governance across CDRH, CDER, and CBER — guidance documents, existing regulations, and how to build a compliant program.
NIST AI 600-1 names 12 generative AI risks. Here's the evidence auditors expect for each one, and how to build it before your next review.
NIST is joining the National Genesis Mission through two of its centers. Here's what's confirmed, what's still open, and what compliance teams should watch.
Google searches for "AI governance framework" just hit a new high. Here's what's driving it and what regulated organizations should do about it now.
Learn how compliance teams can implement the NIST AI RMF Govern function. Practical steps, frameworks, and expert guidance from Regulated AI Consulting.
See how ISO 42001 Annex A controls align with FDA, OCC, CMS, and other regulated industry requirements. Expert mapping guide by Jared Clark, AI Governance Consultant.
Learn how HDS certification protects health data in AI systems. Jared Clark breaks down requirements, costs, and strategy for AI providers. Get actionable guidance.
The US has no federal AI law — but regulated organizations face real legal exposure now. Colorado, NYC, Illinois, Texas, and California have active AI laws with teeth. Here's what they require.
Understand the Colorado AI Act, NYC Local Law 144, and key US AI regulations. Expert guidance from Jared Clark at Regulated AI Consulting. Get compliant today.
Directors face growing AI governance obligations in 2026. Learn what board-level AI oversight requires, key frameworks, and how to avoid regulatory liability. Read now.
When your AI model causes harm, every minute counts. Learn the 6-phase incident response framework regulated organizations need to act fast and stay compliant.
The definitive guide to ISO 42001 for regulated organizations. Jared Clark explains what the standard requires, how it connects to the EU AI Act, and what implementation actually looks like.
Learn the methods, standards, and roles behind algorithmic auditing. Jared Clark breaks down what regulated organizations need to know. Get expert guidance today.
Learn how to build an AI acceptable use policy employees actually follow. Practical framework from Jared Clark, AI governance consultant. Get compliant today.
Navigate AI transparency and disclosure obligations across the EU AI Act, ISO 42001, FDA guidance, and more. Expert breakdown by Jared Clark, AI Governance Consultant.
The North Star Data Center Policy Toolkit signals a new era of AI infrastructure regulation. Learn what it means for your compliance posture. Expert analysis inside.
Proof drills create on-demand audit trails for AI decisions. Learn what they are, why regulators are watching, and how to implement them now. Expert analysis inside.
Federal agencies must better quantify uncertain regulatory effects. Learn what this means for your compliance strategy and how AI governance adds complexity. Expert analysis inside.
Build a pharma AI governance program that satisfies both ISO 42001 certification and FDA regulatory expectations. Expert guidance from Certify Consulting.
FTC ruling shaken, Trump's AI framework drops, and more. Get expert analysis on what this week's regulatory shifts mean for your AI compliance strategy.
How to govern machine learning in validated pharmaceutical systems — ALCOA+, 21 CFR Part 11, CSV for ML, audit trails, and a practical GxP AI compliance framework.
AI overconfidence in administrative and regulatory decision-making poses serious legal risks. Learn what regulated organizations must do now to stay compliant and audit-ready.
Global AI regulation is accelerating. Learn what cross-border AI governance means for regulated organizations and how to stay compliant. Expert analysis by Jared Clark.
NIST's FY 2025 NCST report to Congress highlights safety investigation rigor. Learn what this means for AI governance, risk management, and your compliance strategy.
Learn who owns AI governance in regulated organizations — from the board to the model owner. Jared Clark breaks down every role, RACI, and accountability gap.
Learn what ISO 42001, EU AI Act, and NIST AI RMF actually require for AI model documentation. Expert guidance from Regulated AI Consulting.
Learn how to conduct a proactive AI impact assessment before regulators require it. Step-by-step guidance from an AI governance expert. Get compliant today.
Learn what an AI management system is, how ISO 42001 defines it, and why regulated companies need one. Expert guidance from Jared Clark at Regulated AI Consulting.
Learn how healthcare, finance, and government organizations can build compliant AI governance frameworks. Expert guidance from Jared Clark, JD, MBA at Certify Consulting.
Learn how to build an AI risk management framework from scratch. Step-by-step guidance for regulated organizations from Jared Clark, RAC at Certify Consulting.
Exact EU AI Act deadlines by risk tier, with actionable steps for each phase. Don't miss a cutoff—get compliant with Certify Consulting.
The FDA's artificial intelligence strategy is transforming how regulated companies develop, validate, and govern AI systems. Here is what the 2026 landscape looks like.
The FDA is accelerating its machine learning guidance for drugs, devices, and biologics. Here is what regulated companies must prepare for in 2026 and beyond.
How pharmaceutical companies should assess AI risks across the drug development lifecycle. A practical framework covering GxP, model validation, and regulatory expectations.
Learn how to leverage your ISO 27001 foundation to implement ISO 42001 AI governance. Practical transition guide from Jared Clark, RAC. Get expert help today.
ISO 42001 or NIST AI RMF? Learn which AI governance framework fits your organization with our expert comparison guide. Get clarity now.
Discover why AI governance and quality management share the same DNA—and how integrating both creates a compliance advantage. Expert guide from Certify Consulting.
Your competitors are earning AI governance certifications. Learn what ISO 42001 means for regulated industries and how to close the gap fast. Expert guide.
A definitive guide to AI governance in 2025—covering active regulations, ISO 42001, EU AI Act timelines, and what regulated industries must do now. Expert analysis.