https://compligen.ai/ https://compligen.ai/screens/platform-overview.webp cGen platform overview — AI-native computer system validation software Three-stage validation lifecycle cockpit — design, validate, continuously monitor GxP-regulated computerised systems in one inspection-ready platform. https://compligen.ai/screens/inventory.webp cGen GxP application inventory dashboard Regulator-readiness scored across every validated computerised system in the GxP estate. https://compligen.ai/screens/ai-completeness.webp cGen AI Assistant reviewing GxP validation records AI review of URS, test scripts, and gap analyses against 21 CFR Part 11 and EU GMP Annex 11. https://compligen.ai/screens/inspector.webp cGen Inspector Mode — read-only regulator portal Time-limited, watermarked, audited read-only access for FDA, EMA, and MHRA inspectors. https://compligen.ai/screens/cpv.webp cGen continuous monitoring — real-time GxP analytics Real-time analytics across validated GxP systems with drift and anomaly detection. https://compligen.ai/logo.webp cGen by compligen.AI logo https://compligen.ai/founder-headshot.webp Michael J. Gregor, founder and CEO of compligen.AI 37+ years in FDA regulatory compliance, computer system validation (CSV), and data integrity. Contributor to the FDA Computer Software Assurance guidance process. https://compligen.ai/features https://compligen.ai/screens/document.webp cGen 21 CFR Part 11 e-records and e-signatures Re-authenticated e-signatures with meaning, reason, and MFA; tamper-evident audit trail on every controlled record. https://compligen.ai/screens/test-execution.webp cGen live test execution console Locked step-by-step test execution with screenshot evidence and witness signature capture. https://compligen.ai/screens/risk.webp cGen AI risk assessor — CSA critical thinking Risk-based test scoping aligned to the FDA Computer Software Assurance guidance. https://compligen.ai/screens/ai-gen.webp cGen AI test script generator Automated drafting of IQ, OQ, and PQ test scripts scaled to GAMP 5 risk category. https://compligen.ai/screens/migration.webp cGen migration wizard from ValGenesis, Kneat, Veeva Vault, MasterControl, TrackWise Self-service import of legacy validation records — 12 source connectors, 3–7 days typical. https://compligen.ai/screens/compliance.webp cGen compliance dashboard https://compligen.ai/founder https://compligen.ai/founder-headshot.webp Michael J. Gregor, founder of compligen.AI