Build the AI governance system your regulators expect. Gap assessments, AIMS implementation, and certification prep from a consultant who speaks both AI governance and GxP.
200+
Certification Projects
CPGP
GMP Certified
RAC
Regulatory Affairs
Pharmaceutical companies are adopting AI faster than their governance systems can keep up. Drug discovery teams use machine learning models to predict molecular behavior. Manufacturing operations deploy AI for process optimization, predictive maintenance, and real-time quality monitoring. Quality systems use AI-enabled tools for deviation detection, CAPA trending, and complaint analysis. Regulatory affairs teams explore AI for document preparation and submission review.
Each of these applications carries risk — to patient safety, to product quality, to data integrity, and to regulatory standing. Without a structured governance framework, companies manage these risks inconsistently: individual teams make ad hoc decisions about AI validation, documentation, and oversight that may or may not satisfy regulatory expectations.
ISO/IEC 42001:2023 is the first international standard for Artificial Intelligence Management Systems (AIMS). It gives pharmaceutical companies a recognized, auditable framework to manage AI responsibly — and to demonstrate that management to regulators, partners, and auditors. If you already operate within an ISO-certified quality management system, ISO 42001 is designed to layer on top of it — not replace it.
The Regulatory Landscape
The regulatory expectation for AI governance is forming now. Companies that wait for final enforcement actions to build governance will find themselves scrambling to build systems under pressure that should have been built deliberately.
FDA's January 2025 draft guidance establishes a risk-based approach to AI credibility assessment. Sponsors must define the regulatory question the AI model addresses, assess model risk, develop a credibility assessment plan, and document outcomes. ISO 42001's risk management framework provides the systematic approach FDA expects.
The EU AI Act classifies many pharmaceutical AI applications as high-risk — particularly AI used in medical devices, diagnostics, and clinical decision-support. By August 2026, high-risk systems require conformity assessments, technical documentation, and post-market monitoring. Penalties reach 35 million euros or 7% of global turnover.
The pharma industry's own practical framework for AI in GxP environments. It builds explicitly on ISO 42001 principles and addresses AI system lifecycle management, quality risk management, supplier qualification, and data integrity. ISO 42001 is the management system that operationalizes GAMP AI.
Your existing electronic records requirements don't disappear when AI enters the picture — they intensify. AI systems that generate, process, or store GxP-relevant data must maintain data integrity, audit trails, and validated states. ISO 42001's data governance controls complement your Part 11/Annex 11 compliance program.
The bottom line: No single regulation tells pharmaceutical companies exactly how to govern AI. But every relevant regulation points toward the same fundamentals — risk-based management, documented lifecycle controls, data governance, and human oversight. ISO 42001 organizes all of those fundamentals into a single, auditable system.
Familiar Framework
If you've spent years building quality management systems for pharmaceutical manufacturing, the structure of ISO 42001 will feel familiar. The concepts translate directly — the vocabulary just changes.
| GxP Concept | ISO 42001 Equivalent |
|---|---|
| Quality Policy (ISO 9001 / 21 CFR 211) | AI Policy (Clause 5.2) |
| Quality Risk Management (ICH Q9) | AI Risk Assessment (Clause 6.1, Annex B) |
| Computer System Validation (GAMP 5) | AI System Lifecycle Management (Annex A, A.6) |
| Change Control | AI System Change Management (Annex A, A.7) |
| Data Integrity (21 CFR Part 11 / Annex 11) | Data Governance for AI (Annex A, A.10) |
| Supplier Qualification | Third-Party AI Component Assessment (Annex A, A.9) |
| CAPA System | Continual Improvement (Clause 10) |
| Management Review | AI Management System Review (Clause 9.3) |
| Training and Competency | AI Competency Requirements (Clause 7.2) |
| Document Control | AI Documentation and Records (Annex A, A.5) |
ISO 42001 follows the same Annex SL high-level structure that ISO 9001 and ISO 13485 use. For pharmaceutical companies already operating within ISO-certified management systems, ISO 42001 integration is a natural extension — not a ground-up rebuild. The challenge is knowing which AI-specific controls matter most in a GxP context, which existing QMS processes can be extended rather than duplicated, and where the gaps actually are.
Consulting Services
Every engagement is built on regulated-industry compliance experience — not generic AI consulting frameworks.
1–3 weeks • Foundation engagement
Understand where your organization stands before building anything. The gap assessment inventories your current AI applications across R&D, manufacturing, quality, and regulatory affairs — then assesses each against ISO 42001 control objectives.
3–6 months • Full system build
Build a formal AI management system with your team — one that accounts for your existing QMS maturity, your regulatory context, and your actual AI applications.
4–8 weeks • Certification readiness
Prepare for both the certification auditor and the regulator — because in pharma, passing the audit is necessary but not sufficient.
2–4 months • Extend your existing QMS
For companies that already operate mature quality management systems and want to extend them to cover AI governance — without building a separate parallel system.
Target Audiences
Deploying AI in manufacturing execution, process analytics, predictive maintenance, or quality control — and recognizing that these systems need formal governance beyond what your current computer system validation program covers.
Using machine learning in drug discovery, clinical trial design, or regulatory submissions — particularly those preparing for FDA engagement where AI credibility assessment will be expected.
Developing AI-enabled devices or Software as a Medical Device (SaMD) — where EU AI Act high-risk classification creates immediate compliance obligations by August 2026.
Whose pharmaceutical clients are beginning to ask about AI governance as a supplier qualification requirement — similar to how retail buyers began requiring NSF 455-2 certification from supplement manufacturers.
Who have been tasked with "figuring out AI governance" and need a structured starting point that connects to the regulatory frameworks they already know.
Why Regulated-Industry Experience Matters
I'm Jared Clark. My career has been spent inside regulated industries — building, assessing, and remediating the quality management systems that keep companies in compliance and products safe.
My ISO 42001 practice builds on the same foundation that has made me effective in GMP consulting: the ability to translate regulatory requirements into practical, documented quality systems that organizations can actually operate. The frameworks are different. The discipline is the same.
I bring regulated-industry compliance experience to a space that is currently dominated by IT security consultants and management system generalists. If your organization needs AI governance that speaks the language of GxP, validation, and regulatory affairs — not just information security — that's the gap I fill.
CPGP
Certified GMP Professional
CMQ/OE
Manager of Quality
PMP
Project Management
RAC
Regulatory Affairs
CFSQA
Food Safety Auditor
CSA
Computer Software Assurance
PVM
Pharma Validation Mgmt
JD
Juris Doctor
Common Questions
Answers to the questions pharmaceutical and life sciences companies ask most about ISO 42001.
If you're evaluating AI governance options for your pharmaceutical or life sciences company — whether you're responding to a regulatory inquiry, preparing for EU AI Act compliance, or building governance proactively — the starting point is understanding exactly where you stand.
Free 30-minute consultation. No pitch. No commitment. Just an honest assessment of your AI governance situation and the most practical path forward.
Schedule Free ConsultationJared Clark, CPGP, CMQ/OE, PMP, RAC • Certify Consulting Group