Questions, answered

cGen is AI-native computer system validation (CSV/CSA) software from compligen.AI. It unifies validation, compliance, and continuous monitoring in one inspection-ready environment.

cGen ships with built-in support for 21 CFR Part 11, EU GMP Annex 11, GAMP 5 (2nd Edition), FDA’s FINAL Guidance on CSA (Published FEB 2026), ICH Q9(R1) and Q10, 21 CFR Part 820, ISO 13485, EU MDR/IVDR, PIC/S PI 011-3, and ALCOA++ data integrity principles.

cGen is a cloud-only platform — offered as multi-region SaaS and as a single-tenant private cloud deployment for Enterprise customers. Both deployment options are fully GxP-validated; we do not offer on-premise deployment.

The cGen AI Assistant drafts content but never signs records. Every cGen AI suggestion is logged in the audit trail as machine-generated, and a qualified human reviewer must sign before any record becomes effective — maintaining full Part 11 / Annex 11 electronic records and electronic signature integrity.

Yes — cGen is a GxP software application used to create and maintain validation records, which are themselves GxP records. compligen.AI provides a software validation kit that customers can execute to validate their own instance of cGen before go-live.

Yes. cGen includes automated Software Vendor Audit templates and reporting to support supplier qualification and ongoing vendor oversight, alongside your validation and inventory records.

cGen is in its final design phase ahead of a Q3 2026 public launch. You can join the early signup queue now for free — we invite people to access the software in order, and you decide whether to activate a paid subscription once we go live.

Yes. Every early-access reservation includes a 30-day free trial when cGen launches publicly in Q3 2026, with guided onboarding from a compligen validation engineer.

No. Joining the early signup queue is free and requires no payment information. You only enter payment details if and when you choose to activate your subscription after launch.

Unlimited validation projects, GxP application inventory for up to 100 systems, 25 users, the full cGen AI Assistant suite, Inspector Mode with 5 inspection sessions per month, one ticketing integration, and 24×5 priority support.

Median time to first signed validation document on cGen is 19 days. A full proof of value with one product line typically completes in 4 weeks. Enterprise rollouts across multiple sites take 6 to 10 weeks.

Yes. cGen includes a migration wizard with pre-built connectors for Veeva Vault QualityDocs, MasterControl, ValGenesis VLMS, Kneat Gx, TrackWise, Qualio, Greenlight Guru, Caliber QMS, ETQ Reliance, Pilgrim SmartSolve, IBM Maximo, and SharePoint. The average migration takes 3 to 7 days.

Yes. The migration wizard preserves the full version history, signature manifest, audit trail, and document hash of every migrated record, ensuring continuity for any future inspection.

cGen Growth includes white-glove migration. Enterprise customers receive a dedicated Technical Account Manager and on-site implementation support. Additional professional services are available through our partner network.

Deliverables update automatically whenever a linked requirement, test result, or system configuration changes — so your validation package stays continuously accurate and audit-ready rather than going stale between review cycles.

Yes. cGen has achieved SOC 2 Type II certification covering the security, availability, processing integrity, confidentiality, and privacy trust service principles.

All data is encrypted at rest using AES-256 and in transit using TLS 1.3. Customer data is logically isolated by tenant, with optional single-tenant deployment for Enterprise customers. Backups are encrypted, geographically distributed, and tested quarterly.

Multi-region deployment is supported in the United States, European Union, United Kingdom, and Asia-Pacific. Customer data does not leave the selected region. Inspector access is logged separately and tied to the data location.

Yes. cGen complies with the GDPR for European customer data and supports data subject access, rectification, and deletion requests through the Admin Settings module.

cGen enforces ALCOA++ principles on every record — Attributable, Legible, Contemporaneous, Original, and Accurate, plus Complete, Consistent, Enduring, and Available. Data is encrypted, access-controlled, and fully traceable end to end.