The first GxP-compliant AI framework

GxP compliance was built for one tool at a time. AI doesn't work that way.

Headless GxP is the architecture for regulated R&D in an agentic world — where any tool, any model, and any workflow can plug into a compliant system of record without living inside it.

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Now live — watch the recording at kivo.io

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Watch the Kivo Headless GxP™ Launch

MCP demo, validation framework, live Q&A — recorded June 8, 2026.

ON DEMAND Build Doors, Not Walls. Kivo Headless GxP™ Launch · June 8, 2026
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Our Thesis
01
A walled-off AI model sounds safe. But it can kill your competitive advantage.

Private AI models trained on your data and locked away from other tools sound safe. But they start you behind the curve — and you never recover. The marketplace of tools built on frontier AI evolves orders of magnitude faster than any single vendor can match.

02
GxP Compliance and AI interoperability should not be mutually exclusive.

The belief that you must choose between AI and GxP compliance is a false dichotomy. Headless GxP is a membrane — a protective layer with selective permeability that lets data interact with any tool in the ecosystem, without allowing non-compliant actions.

03
AI does the analysis. The human does the work. We record both.

Agents analyze, cross-reference, and propose. A specific human — under their own authenticated identity — takes the action the system records. The deeper the AI's analysis, the more substantive the human's decision. That relationship is what the architecture enforces.

"Using a model that can't interact with the ecosystem is like running your company on a Blackberry while your competitors are armed with the latest iPhone."
— Toban Zolman, CEO, Kivo
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What is Headless GxP?

The GxP compliance layer that records work wherever it happens. 

Headless GxP separates the system of record from the system of interaction. Regulated content and audit trails live in a validated platform. The work — drafting, analyzing, reviewing — happens wherever your team actually works.

API-first architecture

The UI is built on the same API any external system uses. Programmatic access isn't retrofitted — it's foundational.

REST API

MCP service

Any AI system can interrogate Kivo's content, metadata, and workflow state through the Model Context Protocol.

MCP · June 8

Human-action handoff

Agents analyze and propose. Humans act under their own authenticated identity. The audit trail is unbroken and attribution is always real.

21 CFR Part 11
On Demand

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See Kivo Headless GxP™ in action — MCP demo, validation framework, and live Q&A.

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Built by

Headless GxP™ is the thought leadership home for Kivo's agent-native strategy. For the full platform — regulatory, clinical, quality, and document management — visit kivo.io.