How It Works — ComplianceGxP

From Your Documents to Audit-Ready Answers

Generic RAG retrieves text. ComplianceGxP understands compliance.

Ingest Your Documents

Upload SOPs, validation protocols, regulatory guidelines, deviations, and CAPAs. Each document is parsed (PDF/DOCX/XLSX/TXT), chunked along pharma-aware section boundaries, and embedded into a private FAISS index isolated per namespace.

SOP · Validation Plan · Deviation · CAPA · Regulatory · Audit

25 Years of Pharma Expertise, Built In

Each mode is driven by specialised system prompts written 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” means in the context of GAMP5 Category 4 software.

Domain knowledge you cannot prompt-engineer in an afternoon

Choose Your Compliance Workflow

Each mode runs a structured workflow — not a generic “chat with your docs” interface. QA surfaces sourced policy answers. Deviation runs 5M analysis with classification. CAPA drafts corrective actions with regulatory traceability. CSV produces protocol outlines aligned to IQ/OQ/PQ.

QA Deviation CAPA CSV

Structured, Sourced, Audit-Ready

Every answer cites the exact document and section it came from, with similarity score. Every query is logged in JSONL with timestamp, user, mode, and sources. Outputs match the structure your QA team already knows — ready to paste into your QMS.

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

Architecture at a Glance

FastAPI service. FAISS vector store. Claude Sonnet for generation. SHA-256-hashed keys. JSONL audit. Docker + Caddy for deploy.

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RAG Pipeline

Documents → pharma-aware chunker → local embeddings (all-MiniLM-L6-v2, 384-dim) or OpenAI embeddings → FAISS IndexFlatIP (cosine, threshold 0.3) → Claude Sonnet generation with mode-specific system prompts.

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Multi-Tenant Isolation

Each client gets a separate FAISS index, metadata file, and JSONL audit log under data/clients/<namespace>/. Per-key tier flags (can_ingest, can_read_logs) enforce least-privilege access.

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Validation Package

IQ-CGXP-001 (16 test cases — env, deps, file I/O), OQ-CGXP-001 (33 test cases — auth, ingestion, all 4 modes, audit log), PQ-CGXP-001 template per client. Run via python tests/validation/run_oq.py.

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Agent-Ready Surfaces

HTTP API with auto-generated Swagger UI at /docs. MCP server endpoint at /mcp/ for direct connection from Claude AI & Claude Code. SHARP headers for healthcare agent interop.

Try It in One Minute

The hosted Community Edition is open to everyone: sign up with your email, get 50 free credits every month, upload your own documents, and pay only the actual cost of what you run — transparent, tamper-evident, no subscription.

Need data segregation on your own infrastructure? On-premise & white-label →

What ships in the box:

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

MCP Server

Claude AI & Code interop

SHARP

Healthcare agent protocol

Need a managed instance, validation evidence, or your own SOP library ingested?
See the Private Pilot Programme →

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. The modes and prompts above are not generic AI — they encode how I learned to think through a deviation, a CAPA, a CSV protocol over a 25-year career. That is what you cannot prompt-engineer in an afternoon.

Connect with me on LinkedIn ↗ — I’m building this in the open.

Ready to try this with your own documents?

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

Apply for Free Pilot

How ComplianceGxP Works