Draft CSV Protocols, Deviations & CAPAs in Minutes — Not Days
ComplianceGxP is an AI co-pilot that turns your own SOPs and validation history into first-draft IQ/OQ/PQ protocols, deviation analyses, and CAPAs — every line sourced, every query audit-logged. Built by Mauro Moro, a pharma automation & CSV engineer with 25+ years on the plant floor. GAMP5 Category 4 validated.
The Problem
Your validation and quality teams spend hours searching SOPs, regulatory guidelines, and deviation histories to answer questions they have answered before. Critical knowledge lives in scattered documents, retired employees’ heads, and overloaded shared drives.
Indicative estimates drawn from 25+ years on pharma plant floors and widely-reported industry experience — they describe the shape of the problem, not a single benchmark study.
The Solution: ComplianceGxP
ComplianceGxP builds AI assistants trained on your company’s own documentation. Your team asks questions in plain language and gets accurate, source-referenced answers in seconds — in a system that has passed IQ, OQ and PQ.
4 Pharma Modes
QA, Deviation, CAPA, and Computer System Validation — each driven by purpose-built prompts that encode how a real validation engineer thinks.
GxP Audit Trail
Every query, every response, every source citation logged in JSONL — 21 CFR Part 11 and EU Annex 11 compliant out of the box.
Private Knowledge Base
Your documents stay in your namespace. Per-client FAISS index, per-client API keys, never shared with other tenants.
MCP & SHARP Ready
Connect directly from Claude AI, Claude Code, and agent workflows over the Model Context Protocol. SHARP-compliant for healthcare agent interop.
Why ComplianceGxP
- 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
- Full GAMP5 IQ/OQ/PQ validation package included — not a roadmap promise
- Licensed on-premise deployment, or fully managed for you on dedicated EU cloud infrastructure
Your Documents Stay Yours
The first question every QA lead asks — answered plainly, before you ask it.
- 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. ComplianceGxP is the tool I wished I’d had every time I faced a blank validation-protocol template. It is not a generic chatbot in pharma branding — it is built by someone who knows exactly what a wrong answer costs in a GMP context, and designed to avoid them.
Connect with me on LinkedIn ↗ — I’m building this in the open.
Complementary to Your QMS & CSV
— Not a Replacement
QMS platforms like Veeva Vault, MasterControl, and TrackWise are systems of record for SOPs, deviations, CAPAs, and audit trails. CSV lifecycle tools like KNEAT and COMOS manage validation protocols, test execution, and traceability matrices. Both are essential — but neither helps your team write the underlying content. ComplianceGxP fills that gap as the AI co-pilot for compliance content creation, drafting the protocols, deviations, CAPAs, and assessments that then feed into your QMS or CSV system.
Draft CSV Protocols
Generate IQ/OQ/PQ outlines aligned to your SOPs in minutes, not days. Then feed them into your QMS workflow for sign-off.
Investigate Deviations
Structured 5M root cause analysis grounded in your historical deviation library — faster than starting from a blank template.
Draft CAPAs
Corrective and preventive actions with regulatory traceability, ready to paste into your QMS — not to write from scratch.
Regulatory Gap Analysis
Map your SOPs against ICH, FDA, and EMA guidance to surface gaps before an auditor does.
See it draft from real compliance content
Start with the free Community demo — no signup, no commitment, try it on real GxP questions right now. When you’re ready, a limited number of pharma, biotech, and CDMO teams can run a free 90-day private pilot trained on their own document library.