Early access — now open
The cGen AI-native
Smart GxP platform
cGen digitalises your full validation lifecycle — validation, compliance, and continuous monitoring — in one inspection-ready environment built for FDA, EMA, and MHRA-regulated QA teams worldwide.
Inspection-ready
GxP Application Inventory
The master register inspectors ask for first — auto-populated and cGen AI-reviewed.
Our team has delivered for
By the numbers
Built for teams who no longer entertain the exorbitant resources and costs of validating GxP software using the traditional CSV approach.
50%
Less time to implement
vs traditional CSV on large GxP systems — CTMS, EDC, ERP (SAP, Oracle)
72%
Less manual validation effort
measured across 50 customers
100%
Inspection-ready inventory
auto-built from your projects
<2s
cGen AI anomaly detection latency
across your monitored systems
Smart GxP
One platform. Three pillars. Zero gaps.
Validation, compliance, and monitoring — unified inside one cGen AI-enabled, GxP-compliant environment.
Validation
Validate your systems end-to-end — IQ / OQ / PQ, CSV / CSA, risk-based testing, electronic signatures.
Audit & Inspection Readiness
Always audit-ready — regulatory inspection readiness, internal audit readiness, and client audit readiness with auto-built GxP inventory and signed PDF exports.
Continuous Monitoring
Ongoing assurance your systems stay in control — real-time analytics and automated alerts.
★ The headline feature
The inventory
inspectors ask for first.
Auto-built from every validation project, the GxP Application Inventory is your single source of truth — and the artefact inspectors ask for within the first 30 minutes of any walk-in.
Auto-populated from your validation projects
No double-entry. Every project automatically lands as an inventory record.
Inspector Mode — read-only, watermarked, time-limited
Generate a one-link inspection portal in 10 seconds.
GxP Inventory List — auto-populated
Master register auto-built from every validation project with cGen AI review.
Signed PDF/A-3 export for archival
Long-term archive format with cryptographic checksum.
Readiness
85 / 100
Everything you need
A complete validation stack — no add-ons required.
cGen AI Assistant
Draft URS, FRS, test scripts and risk records from your intent in seconds — purpose-built for your validation lifecycle.
GxP Application Inventory
Always-current, inspection-ready GxP Inventory List with cGen AI review.
21 CFR Part 11 / Annex 11 e-Records & e-Signature
21 CFR Part 11 and EU GMP Annex 11 compliant electronic records and electronic signatures — re-auth, meaning, and reason bound to every approval.
Live Test Execution
Locked execution console with screenshots, witness sigs, auto-deviations.
Continuous Monitoring
Real-time analytics and automated compliance alerts.
Inspector Mode
Branded read-only portal you share with regulators — fully audited.
Document Migration
Seamlessly migrate your existing GxP supporting validation documents into cGen.
Ticketing Integrations
Jira, ServiceNow, Veeva Vault, SharePoint — two-way sync.
cGen Hub
Periodic Review status, Change Controls, Application Lifecycle Status, Deviation & CAPA tracking.
14 models running
cGen AI ASSISTANT
cGen AI that QA, regulatory bodies, clients, and ISO auditors trust.
Our cGen AI Assistant was purpose-built for the complete validation lifecycle — architected by our founder with 37+ years of deep expertise in Data Integrity, CSV, and CSA across the FDA-regulated industry. Unlike competitors who bolt on generic AI tools at extra cost, every cGen AI response is grounded in decades of real-world regulatory, internal, and client audit experience.
Every cGen AI suggestion is logged in your audit trail, explainable, and reviewer-controlled. The cGen AI Assistant drafts, but a qualified human signs.
cGen AI Requirement Generator
URS/FRS draft from intent
cGen AI Test Script Generator
IQ/OQ/PQ steps + evidence
cGen AI Risk Assessor
CSA Critical Thinking
cGen AI Gap Analyzer
Part 11 / Annex 11 audit
GxP Inventory List
Auto-populated register
cGen AI Real-time Analytics
Trend monitoring & alerts
Early access — now open
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