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Comparison · 2026 edition

cGen vs Qualio

Enterprise-grade validation with purpose-built cGen AI — when you need more than basic QMS. See what's included with cGen vs. what costs extra or isn't available elsewhere.

Capability
cGen — Included
Qualio
cGen AI Assistant (6 production cGen AI flows)
Included in every tier — no extra charge
Basic AI features in higher tiers
GxP application inventory
Built-in, inspection-ready, cGen AI-reviewed
Not availableNot offered
Inspector Mode (read-only portal)
Yes — time-limited, watermarked, audited
Not availableNot offered
Continuous Monitoring
Built-in real-time analytics + trend monitoring
Basic dashboards only
Enterprise scalability
Built for mid-market to enterprise from day one
Designed for SMBs — limited enterprise features
Implementation time
~6 weeks (proof of value in 4)
4–8 weeks (simpler scope)
Validation depth
Full CSV/CSA lifecycle with risk engine
Basic document control + QMS
Migration from competitor
Wizard with 12 source connectors, 3–7 days
Manual import process
21 CFR Part 11 / Annex 11 e-records & e-sig
Re-auth + meaning + reason + MFA
Basic e-signature
Transparent pricing
Yes — public tiers, no quote required
Published tiers, but limited feature set per tier

Why teams are choosing cGen

  • cGen AI Assistant is included — not an add-on. Six production cGen AI flows ship with every tier. No extra modules. No extra cost. Our cGen AI is purpose-built by our founder's 37+ years of regulatory expertise, not a generic plug-in.

  • GxP inventory is inspection-ready out of the box. No separate purchase, no separate implementation project — it's built in.

  • Continuous monitoring is included. Real-time analytics and trend monitoring ship with the platform at no additional charge.

  • Inspector Mode gives auditors direct, read-only access. Time-limited, watermarked, fully audited — not available on competitor platforms.

  • Pricing is public and transparent. Our plan tiers are visible up front — no quote runarounds, no surprise line items.

  • Implementation is faster. Mean time to first signed validation document on cGen is 19 days, vs. reported industry average over 60.

  • Migration is self-service. 12 source connectors, 3–7 days — no paid professional services engagement required.

See cGen against your real data

Book a 30-minute working session with our team.

cGen

cGen — AI-native computer system validation software for life sciences. Design, validate, and continuously monitor your GxP-regulated systems in one inspection-ready environment.

contact@compligen.ai(833) 916-CGEN(833-916-2436)

Merchandise Mart Plaza, Suite 470, Chicago, IL 60654

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