How ComplianceRAG Works

25 years of pharma expertise encoded into purpose-built compliance modes — not a generic chatbot

From Your Documents to Audit-Ready Answers

Generic RAG retrieves text. ComplianceRAG understands compliance.

01 📂

Ingest Your Documents

Upload SOPs, validation protocols, regulatory guidelines, and internal policies. Each document is parsed, chunked, and semantically indexed — searchable by meaning, not just keywords.

SOP-VALID-001 · GAMP 5 Second Edition · 21 CFR Part 11 · ICH Q10
02 🧠

25 Years of Pharma Expertise, Built In

This is where ComplianceRAG differs from any off-the-shelf RAG tool. Every mode is driven by specialized prompts developed from deep GxP experience — encoding how a real validation engineer thinks: which sections of a deviation matter, what a CAPA must contain to survive an FDA inspection, what "risk-based approach" means in the context of GAMP 5 Category 4 software.

Domain knowledge you can't prompt-engineer in an afternoon
03 🎯

Choose Your Compliance Workflow

Each mode runs a structured compliance workflow — not a generic "chat with your docs" interface. Q&A mode surfaces sourced policy answers. Deviation mode classifies and triggers 5M analysis. CAPA mode drafts corrective actions with regulatory traceability. CSV mode generates protocol outlines aligned to IQ/OQ/PQ phases.

Q&A Deviation CAPA CSV Protocol
04 ✅

Structured, Sourced, Audit-Ready

Every answer cites the exact document and section it came from. Outputs match the structure your QA team already knows — deviation reports, CAPA tables, protocol sections. Ready to paste into your DMS, not to edit from scratch.

[Major Deviation] → 5M Root Cause → Actions → Owner
Source: SOP-DEV-042 §4.1 · 21 CFR Part 11 §11.10(e)

Try the Community API — Free

No account. No registration. Query the public regulatory knowledge base right now.

Ask anything about GxP compliance

The Community API is trained on publicly available regulatory frameworks: GAMP 5 Second Edition, 21 CFR Part 11, EU Annex 11, ICH Q7/Q10, and EU AI Act guidance. Every answer cites its source.

"What documents are needed for IQ in a GAMP 5 Cat 4 system?" "How does 21 CFR Part 11 apply to electronic batch records?" "What are the EU Annex 11 requirements for backup and recovery?" "Draft a CAPA for a temperature excursion in a controlled storage area"
Try the Live API

10 free queries per day · Public regulatory knowledge base · No registration

Self-Host in 5 Minutes

Run ComplianceRAG on your own infrastructure — bring your own documents, your own API key, your own data boundary.

github.com/llmops-pro/compliancerag
Docker image · docker-compose.yml · API docs
 
# 1. Clone the quick-start repo
git clone https://github.com/llmops-pro/compliancerag
cd compliancerag

# 2. Set your Anthropic API key
cp .env.example .env
#    → edit .env and add: ANTHROPIC_API_KEY=sk-ant-...

# 3. Start the stack
docker compose up -d

# 4. Open the web UI
#    → http://localhost:8000
1

Ingest Your Documents

Drop PDFs, Word docs, or plain text into the docs/ folder, then run the ingest command to build your private knowledge base.

docker compose exec api \
  compliancerag ingest \
  --client my-company \
  --path ./docs/
2

Query the API

Every answer returns source citations with similarity scores. Use the web UI or call the API directly from your existing tools.

curl -X POST http://localhost:8000/query \
  -H "X-API-Key: your-key" \
  -d '{"query":"What is our CSV policy?",
     "mode":"qa","client":"my-company"}'
3

Four Compliance Modes

Switch modes to match your workflow. Q&A for policy lookup, Deviation for structured RCA, CAPA for corrective action drafts, CSV for validation protocol outlines.

mode: "qa"        # sourced Q&A
mode: "deviation" # 5M analysis
mode: "capa"      # CAPA drafting
mode: "csv"       # IQ/OQ/PQ outlines
4

Multi-Tenant & Isolated

Each client gets an isolated FAISS index and per-client API keys. Perfect for CDMOs running separate instances for different sponsors.

data/clients/
  ├── sponsor-a/   # isolated
  ├── sponsor-b/   # isolated
  └── internal/    # your docs

Community image includes:

QA Mode
Sourced Q&A · citations
Deviation Mode
5M RCA · classification
CAPA Mode
Corrective action drafts
CSV Mode
IQ / OQ / PQ outlines
GAMP5 Validation
IQ/OQ/PQ test suite
Audit Trail
JSONL · per query

Need setup help, a GAMP5 validation package, or your own SOP library ingested?
See the Private Pilot Programme →

Ready to try this with your own documents?

We're accepting a limited number of qualifying pharma and CDMO teams for a free 90-day pilot — ComplianceRAG trained on your actual SOPs, validation protocols, and regulatory guidelines.

Apply for Free Pilot