AI governance built
before the FDA asks for it.
Compliance Group is the only life sciences compliance firm with an ISO/IEC 42001-certified AI Management System — building AI governance frameworks that make every decision traceable and explainable, keeping you inspection-ready before the FDA finds the gap.
The FDA is already including AI governance questions in current inspections. ISO/IEC 42001 is the standard inspectors are beginning to reference. The window between 'optional' and 'expected' is 12–18 months. Organizations without frameworks are getting observations today.
What AI governance looks like when it's built to hold up under scrutiny.
Defensible AI governance before the auditor asks
ISO/IEC 42001-aligned framework, model risk assessments, human oversight mechanisms, audit trails—documented and defensible before your next inspection.
Compliance that scales with AI adoption
A governance framework that grows with your AI program—not a point-in-time assessment that's outdated when your team deploys the next model.
AI Validation your team can actually count on
A proven AI Validation approach that makes AI dependable by ensuring models are transparent, testable, and inspection-ready throughout their lifecycle. A scalable approach that stood the test of audits at major Life Sciences companies.
One certified partner across AI and compliance
The team that built AI under ISO/IEC 42001 is also the team governing your compliance program. No interpretive gaps between your AI vendor and your QA team.
Most life sciences organizations are dangerously behind—and the FDA is already asking questions.
87% of life sciences companies plan to deploy AI in quality processes within 24 months. Fewer than 12% have a documented AI governance framework. That's not a technology gap. It's a regulatory exposure gap—and it's growing every quarter.
AI is in the building—governance isn't
Classification, summarization, decision support—your teams use AI tools. There's no documented framework, no ISO/IEC 42001 posture, and no audit-ready trail.
FDA AI inspection questions are already active
Inspectors are asking about AI governance controls in current inspections. Organizations without documented frameworks are receiving observations. This is not a future risk.
EU AI Act timelines are firming up
High-risk medical AI has specific conformity assessment requirements. Human oversight mechanism documentation must exist before market entry.
ISO/IEC 42001 requires operational governance, not a document
The AI Management System standard covers risk assessments, impact analyses, monitoring, and continuous improvement—not just a policy document with the right acronyms.
Audit trail requirements are different for AI systems
AI decision support in a regulated workflow requires specific audit trail architecture—what the model saw, what it recommended, what the human decided, and why.
Generic AI governance frameworks don't translate
ISO/IEC 42001 designed for enterprise AI doesn't map directly to GxP workflows. You need a firm that understands both the standard and the regulated environment simultaneously.
AI governance built on 25 years of GxP expertise.
ISO/IEC 42001-Aligned AI Governance Program
Risk assessments, governance documentation, model validation protocols, human oversight mechanisms, monitoring frameworks, and ongoing compliance. Built before the FDA asks.
AI System Validation and CSA-Aligned Testing
Validation protocols for AI systems in regulated environments—aligned to FDA's CSA guidance, ISO/IEC 42001, and GAMP 5 Second Edition. Risk-based, defensible, audit-ready.
Continuous Compliance Intelligence
CLAIRE, an agentic AI platform purpose built for Life Sciences industry with agents that turn weeks of QA, RA, and compliance work into hours - with the audit evidence your inspector accepts.
AI Regulatory Strategy and Inspection Readiness
FDA AI framework interpretation, EU AI Act compliance roadmap, ISO/IEC 42001 certification pathway, and ongoing regulatory monitoring—so your governance framework stays current.
Continuous compliance intelligence on top of your existing stack.
CLAiRE AI Agentic Platform runs on top of your existing Veeva Vault, MasterControl, or other validated platforms. No rip-and-replace. No multi-year integration project. Deploys in weeks.
- Purpose built for Life Sciences industry to drive a 360 degree compliance posture
- AI Agents include Automated Audit Trail Reviews, Drift / User Access Reviews, Validation Doc Generator, Quality Reviews, Quality Management Reviews & more
- Every AI answer leaves a sealed trail. Every AI output passes two quality checks before reaching you
- Governed under ISO/IEC 42001 — every recommendation is explainable and traceable
- Deployed by the same team that built it — no handoff, no integration risk
Already have a quality technology stack? CLAIRE deploys on top of your existing systems. Building from scratch? iQuality embeds AI governance natively across DX, VX, and QX. Both operate under our ISO/IEC 42001-certified AI Management System—the only certified AI Management System from a Life Sciences compliance company.
The only AI Governance Certification Program built exclusively for Life Sciences compliance.
To our knowledge, this is the only AI Governance certification program offered by a Life Sciences compliance company. A 15-lesson curriculum covering everything your team needs to govern AI responsibly — from policy frameworks to inspection-ready documentation.
AI Governance Fundamentals
Policies, controls, and validation frameworks needed to scale AI responsibly under ISO/IEC 42001 and FDA CSA guidance.
Digital Quality Foundation
Ensuring your QMS, DMS, and validation ecosystem are ready to support AI initiatives at enterprise scale.
AI-Powered Compliance Automation
Identifying opportunities to automate high-effort activities — from Audit Trail Reviews to Quality Management Reviews — using compliant AI Agents.
Certification & Credential
15-lesson curriculum. Earn a verifiable certification that demonstrates your organization's commitment to responsible AI governance in regulated environments.
The certification stack behind every Compliance Group AI recommendation.
ISO/IEC 42001:2023 Certified
The only ISO/IEC 42001-certified AI Management System in life sciences compliance. Every AI recommendation is explainable, traceable, and audit-ready.
SOC 2 Type 2 Compliant
Independently audited controls. Proven operational effectiveness. Security, availability & confidentiality assured.
ISO/IEC 27001:2022 Certified
International information security standard. Risk-based security management. Strong data protection for regulated environments.
Book a Free AI Readiness Assessment.
45 minutes with a senior expert—not a sales rep. We score your AI governance posture, validation approach, and inspection readiness. Written risk brief. No commitment.
Book Your Free Assessment