Features
Smarter GxP Validation
NOT Harder GxP Validation
The complete validation stack — every capability you'd otherwise stitch together from 5 vendors, built native and GxP-compliant from day one.
Complete Validation Stack
The first cGen AI-enabled platform to unify validation, compliance, and monitoring in one inspection-ready environment. No bolt-ons. No data silos.
- Validation — Projects, URS/FRS, IQ/OQ/PQ, RTM, Deviations, CAPA
- Audit & Inspection Readiness — Regulatory, Internal, and Client Audit Readiness
- Continuous Monitoring — Real-time Analytics
- Cross-system Lifecycle Health Score per product
GxP Application Inventory
The master register inspectors ask for first. Auto-populated, cGen AI-reviewed, and signed-PDF exportable.
- Regulator Readiness Score (0-100) across your whole estate
- Auto-populated from your validation projects — no double-entry
- GxP Inventory List — auto-populated from your validation projects
- Inspector Mode: time-limited, read-only, watermarked sharing link
- Signed PDF/A-3 export with cryptographic checksum
21 CFR Part 11 / Annex 11 — Electronic Records & Electronic Signatures
Trustworthy electronic records and compliant electronic signatures — re-auth, meaning, reason — bound to every record. Tamper-evident audit trail forever.
- Re-authentication on every signature event
- Meaning of signature (Authored / Reviewed / Approved / Witnessed / Rejected)
- Mandatory "reason for change" on every controlled-record edit
- Cryptographic signature hash + full audit-trail entry
- ALCOA++ data-integrity markers on every record display
Live Test Execution Console
Step-by-step execution with screenshot capture, witness signatures, and one-click deviation creation when a step fails.
- Locked execution mode — no script edits mid-run
- Per-step Pass / Fail / N/A with required actual-result entry
- Drag-drop screenshot / file evidence per step
- Tester + Witness signatures captured inline
- Auto-deviation when a step fails — fully linked
Continuous Monitoring
Real-time analytics and automated compliance alerts — keeps your systems in control between audits.
- Real-time analytics across all monitored parameters
- Trend analytics across your estate
- Auto-trigger investigations when anomalies are detected
- Periodic Review tracking and scheduling
- Automated compliance alert rules
Inspector Mode
A branded, read-only, watermarked portal you generate in 10 seconds and share with regulators, internal auditors, or client auditors — fully audit-trailed.
- Time-limited, read-only, watermarked sharing link
- Branded portal with your company logo and colors
- Full audit trail of every inspector session
- Scoped access — choose exactly which projects and records are visible
- One-click generation — no IT tickets, no waiting
cGen AI Assistant
Purpose-built cGen AI flows that drive the validation lifecycle from URS drafting to real-time analytics — every suggestion explainable, reviewer-controlled, and grounded in 37+ years of regulatory expertise.
- cGen AI Requirement Generator — paste system spec → URS items
- cGen AI Test Script Generator — per requirement IQ/OQ/PQ drafting
- cGen AI Risk Assessor — CSA Critical Thinking with mitigations
- cGen AI Gap Analyzer — Part 11 / Annex 11 / GAMP 5 checklist scan
- GxP Inventory List — auto-populated register
- cGen AI Real-time Analytics — trend monitoring & compliance alerts
GxP Document Migration
Seamlessly migrate your existing GxP supporting validation documents into cGen from Veeva Vault, MasterControl, ValGenesis, Kneat, TrackWise, and 20+ others.
- Pre-built connectors for top 12 competitors
- Field mapping studio with visual preview
- Dry-run + signed-off cutover
- Full audit trail of every migrated record
- Average migration: 3–7 days (vs 12+ weeks DIY)
Ready to see it on your data?
15-minute personalised demo. No slides.
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