How to Get Started
Three ways to use ComplianceGxP — from a free community demo to a fully managed private instance on your own document library.
- Sandbox knowledge base with public regulatory content
- GAMP5, 21 CFR Part 11, EU Annex 11, ICH Q7/Q10
- QA mode — sourced answers with citations
- 10 free queries per day
- Demo API key on request
- Try before you commit
- Your SOPs, protocols & guidelines ingested
- Private namespace — isolated FAISS index
- All 4 modes: QA, Deviation, CAPA, CSV
- Full team access for 90 days
- GAMP5 validation package (IQ/OQ/PQ)
- 2 feedback sessions — shape the roadmap
- Everything in Private Pilot
- Ongoing maintenance & updates
- MCP & SHARP integrations
- Multi-tenant for CDMOs (per-sponsor isolation)
- SLA & dedicated support
- Change-control workflow built in
| Feature | Community | Private Pilot | Professional |
|---|---|---|---|
| Knowledge base | ✓ Public regulations | ✓ Your docs | ✓ Your docs |
| Private namespace / FAISS index | — | ✓ | ✓ |
| Source-cited answers | ✓ | ✓ | ✓ |
| QA mode | ✓ | ✓ | ✓ |
| Deviation, CAPA, CSV modes | — | ✓ | ✓ |
| GAMP5 IQ/OQ/PQ package | — | ✓ | ✓ |
| JSONL audit trail | ✓ | ✓ | ✓ |
| MCP & SHARP integrations | — | — | ✓ |
| SLA & ongoing support | — | — | ✓ |
| Cost | Free | Free | TBA · 2026 |
What the Pilot Covers
Pilot teams get full access to a private ComplianceGxP instance for 90 days — trained on their own document library, at no cost.
Document Ingestion
SOPs, validation protocols, regulatory guidelines, deviation records, training documents — your full compliance library indexed and searchable via AI.
4 Compliance Modes Active
QA for policy lookup, Deviation for structured 5M RCA, CAPA for corrective-action drafting, CSV for IQ/OQ/PQ protocol outlines.
GAMP5 Validation Package
IQ-CGXP-001 (16 test cases), OQ-CGXP-001 (33 test cases), and a PQ-CGXP-001 template scoped to your instance. Ready for inspection from day one.
Audit-Ready From Query One
Every query logged in JSONL with timestamp, user, mode, sources, and answer. 21 CFR Part 11 and EU Annex 11 traceability built in.
Qualifying teams: mid-size pharma, CDMO, or biotech in DACH/EU · GxP environment required · No contracts
Apply for Free PilotBefore You Hand Over a Single SOP
The questions your QA and IT teams will ask — answered plainly.
- Isolated per client. Your documents live in your own namespace with a dedicated vector index and dedicated API keys — never co-mingled with another tenant.
- Never used to train any AI model. Generation runs on Anthropic’s Claude API, which does not train on data sent through it. Your content is used only to answer your own team’s queries.
- On-premise deployment available for validated environments. The licensed on-premise edition runs entirely on your infrastructure — your document library and vector index never leave your servers; only the per-query prompt is sent to the LLM provider.
- Or fully managed for you on EU cloud infrastructure, with your document store kept in the EU.
- Every interaction is logged — including refused queries. 21 CFR Part 11 / EU Annex 11 audit trail, with a tamper-evident record of both answered and blocked requests.
- A Data Processing Agreement (DPA) is available for managed deployments.
Who’s Behind ComplianceGxP
Mauro Moro — Founder & Builder
I spent 25+ years in pharma automation, MES/SCADA, and GxP computer system validation — on real plant floors, through real FDA and EMA inspections. When you run a pilot, you are not handing your documents to a faceless vendor. You are working with someone who has sat on your side of the audit table and knows exactly what a wrong answer costs in a GMP context.
Connect with me on LinkedIn ↗ — I’m building this in the open.
Not ready for a pilot yet?
Start with the free Community demo — no registration, no commitment. Try ComplianceGxP on real compliance questions right now.
Explore Community