The questions leadership is now being asked
By sponsors in RFPs, by auditors, and increasingly by regulators.
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Where is AI used in our GxP work?
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Who owns each AI risk?
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What evidence would we show an inspector?
If any answer is unclear, that is where we start.
ISO/IEC 42001 Aligned approach | EU AI Act Impact assessment | ICH E6(R3) Risk-based Quality | ISO 9001 · 27001 · 22301 Certified foundation
What Is AI Compliance as a Service?
AI Compliance as a Service is an outsourced model in which Ephicacy helps regulated life sciences organizations govern artificial intelligence. It covers AI inventories, risk assessments, policies, controls, third-party AI oversight, model validation support, and ISO/IEC 42001 readiness, delivered through the quality systems already used for GxP compliance.
How Ready Is Your AI Governance?
Answer five statements to see where you stand. Nothing is stored or sent.
We keep a current inventory of AI used in regulated processes.
Each AI system has a named owner and documented risk assessment.
Changes to AI models go through our change-control process.
We assess the AI inside third-party vendor tools.
We could show an auditor evidence of AI oversight today.
Answer the statements
Your result and a suggested starting point will appear here.
Early Stage
Begin with AI governance readiness: inventory AI in use and assign owners before scaling further.
Foundations in Place
Focus on AI risk management and governance framework development to close control gaps.
Well Advanced
You may be ready for an ISO/IEC 42001 gap assessment and audit-ready evidence review.
–/5
Answer the statements
Your result and a suggested starting point will appear here.
Why AI Governance Matters Now
Regulation, buyers, and inspectors are converging on the same expectation: that AI in regulated work is inventoried, risk-assessed, controlled, and evidenced.
Regulation Is Phasing In
EU AI Act obligations for high-risk systems, including AI in medical devices and SaMD, phase in over 2026 and 2027.
Buyers Are Asking
Sponsors increasingly include AI governance in vendor qualification and RFP criteria.
Few Are Certified
Only a small number of life sciences organizations hold ISO/IEC 42001 certification, so early governance remains a real differentiator.
Our AI Compliance Services
Six services, available individually or as a continuing program, take you from discovering where AI is used to evidencing its control.
Understand
Control
Evidence
AI governance should not sit beside your quality system. It should be part of it.
The Ephicacy approach
Why Ephicacy for AI Compliance
Ephicacy brings AI governance into the quality and risk systems life sciences leaders already trust, delivered by an ISO-certified CRO with 0 critical findings in its history.
- Governance through quality Built on risk management, change control, CAPA, and supplier oversight your auditors already recognize.
- We practice what we advise Our own certified ISO 9001, 27001, and 22301 systems are the foundation of our ISO/IEC 42001 program.
- Credentialed specialists Certified ISO Lead Auditors, ISO/IEC 42001 Lead Auditor and ISO/IEC 42001 Lead Implementer for AI, and MIT Generative AI in Pharma credentials.
- Practical, not theoretical Frameworks designed for adoption and day-to-day operation in GxP, GDPR, and HIPAA environments.
Who We Support
- Pharmaceutical Sponsors
- Biotechnology Companies
- CROs
- Medical Device and SaMD Manufacturers
- Digital Health Companies
- Enterprise Quality Teams
- AI and Innovation Teams
- Technology and Data Leaders
