Your Compliance Team Deserves Better Than Ctrl+F

AI-powered compliance assistants purpose-built for DACH pharma and CDMO teams — trained on your SOPs, protocols, and regulatory guidelines.

See It In Action Apply for Free Pilot

The Problem

Your validation and quality teams spend hours searching through SOPs, regulatory guidelines, and deviation histories to answer questions they've answered before. Critical knowledge lives in scattered documents, retired employees' heads, and overloaded shared drives.

30% of a QA specialist's time lost to manual document search
3–6 weeks average delay on batch release caused by unresolved compliance queries
40% of audit findings trace back to missing or inaccessible documentation

The Solution: ComplianceRAG

ComplianceRAG builds custom AI assistants trained on your company's own documentation. Your team asks questions in plain language and gets accurate, source-referenced answers in seconds.

⚡

Instant Answers

Your SOPs, protocols, and guidelines become a searchable AI knowledge base. Every answer cites the source document.

🛡

GxP-Aware

Built by engineers who understand GAMP5, 21 CFR Part 11, and ICH Q-series. No generic chatbot hallucinations.

📄

Compliance Modules

Deviation investigation helper, CAPA writing assistant, CSV protocol drafts, and gap analysis tools.

🇳🇬

Secure & Swiss-Hosted

Your data runs on dedicated infrastructure in Switzerland, fully isolated in its own container. Full audit trail of every query.

Infrastructure & Compliance

Client data is hosted in Switzerland, fully isolated in its own container. Our infrastructure holds:

SOC 2 Type 2 ISO 27001 ISO 27017/27018 BSI C5 HDS HIPAA GDPR/FADP

All compliance reports available under NDA.

🌍

ComplianceRAG Community Edition — Free API

Any pharma or CDMO team can query our public regulatory knowledge base for free. No account, no contract, no commitment. GAMP5, 21 CFR Part 11, EU Annex 11, ICH Q7/Q10, and EU AI Act guidance — available to everyone.

Why ComplianceRAG

  • Built on 25+ years of pharma automation, MES/SCADA, and GxP validation experience
  • Understands what "wrong answers" look like in a GMP context — designed to avoid them
  • Deep domain expertise: GAMP5, 21 CFR Part 11, ICH Q7/Q10, EU Annex 11, EU AI Act
  • Not a generic chatbot — every answer cites the source document in your library
  • GAMP5 validation package included: IQ, OQ, PQ protocols and test evidence

Selected Engagements

The domain expertise behind ComplianceRAG comes from real deployments in regulated environments.

🏭

Global MES Rollout

GAMP5 IQ/OQ/PQ validation across 12 manufacturing sites for a Top-10 global pharma manufacturer. Full CSV documentation and deviation handling.

🔧

SCADA Modernization

Legacy SCADA migration with compliance continuity for a Swiss CDMO. Architecture redesign, 21 CFR Part 11 alignment, and change control implementation.

🤖

GxP AI Readiness

EU Annex 11 gap analysis and AI readiness assessment for a European biotech scale-up preparing for first GMP manufacturing.

Ready to stop searching and start finding?

We're accepting a limited number of qualifying pharma and CDMO teams for a free 90-day pilot. No contracts, no commitments.

Apply for Free Pilot