GxP AI Validation · FDA · EMA · PIC/S

AI Validation for GxP Environments.
Audit-Ready from Day One.

NexGen GxP AI is the first company purpose-built to validate agentic AI for pharma and biotech. Pre-built qualification frameworks. Immutable audit trails. Regulatory-native architecture for 21 CFR Part 11, Annex 11, and PIC/S.

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21 CFR Part 11 · FDA Computer Software Assurance EU GMP Annex 11 PIC/S PI 011-3 · Harmonized Compliance ICH Q10 / Q12 · Lifecycle Management

The Problem

Three reasons AI stalls in GxP environments

Every pharma and biotech company wants to deploy AI in manufacturing and clinical operations. Most can't — not because the technology isn't ready, but because the validation framework isn't.

Validation Takes Too Long

Under FDA's CSA guidance and EU Annex 11, AI systems require IQ/OQ/PQ qualification, risk assessments, and performance monitoring documentation. From scratch, this takes 6–18 months. That window kills AI initiatives before they start.

AI Creates Audit Risk

When an FDA inspector asks how your AI made a batch release decision, most systems cannot answer. No traceable rationale. No immutable decision log. No human-in-the-loop gate. That's a Form 483 — or worse.

Regulatory Change Breaks Systems

FDA CSA updates. Annex 11 revision. ICH Q12 changes. Every regulatory shift potentially triggers AI revalidation. Without a systematic change impact process for AI, you're perpetually scrambling.

Our Platform

Built for regulatory reality — not adapted to it

We designed our validation framework from the regulatory requirements inward. Every architectural decision is traceable to a specific FDA, EMA, or PIC/S requirement.

Pre-Built Validation Framework

Our AI-extended V-model includes pre-built IQ/OQ/PQ templates, AI Performance Requirements specifications, and Ongoing Performance Monitoring protocols — built around FDA CSA, Annex 11, and PIC/S from the ground up.

Classification matrix — batch release, clinical, scheduling, agentic orchestrators
Risk-based qualification — FMEA for AI decision points with human oversight mapping
8-document validation package — Validation Plan through Ongoing Monitoring Plan

Audit-Ready Agentic Architecture

Every agent action touching a GxP record generates a complete, immutable audit entry. Every decision is traceable. Every change is assessed for regulatory impact. Every human gate is enforced.

// Audit trail entry — batch release AI
agentId: "nexgen-release-v2.1.4"
decision: "RELEASE — Batch 24-1103A"
rationale: "All 14 CPPs within spec"
inputHash: "sha256:a3f8c2..."
confidence: 0.9983
humanReview: true
timestamp: "2026-03-30T14:22:07Z"

Regulatory Coverage

Mapped to the regulations that govern your operations

Our platform is designed against the specific requirements of the frameworks your quality team already knows — not adapted after the fact.

21 CFR Part 11 FDA CSA (2022) EU GMP Annex 11 EMA AI Reflection Paper PIC/S PI 011-3 ICH Q10 ICH Q12 Swissmedic (Annex 11-aligned)

Competitive Landscape

Why generic AI vendors and consultants fall short

Capability	NexGen GxP AI	Generic AI Vendors	Traditional Consultants
Pre-built validation templates (IQ/OQ/PQ)	✓ Core	✗	✗
Audit-ready architecture from day one	✓ Core	✗	Months to build
Agentic AI expertise	✓ Core	Partial	Rare
21 CFR Part 11 / Annex 11 native	✓ Mapped by design	✗	Partial
Continuous drift monitoring	✓ Built-in SPC	Partial	✗
AI change control automation	✓ Automated	✗	Manual
Cell therapy / biologics focus	✓ Specialized	Generic	Generalist

AI Validation for GxP Environments. Audit-Ready from Day One.