GxP compliance authoring · by LLMOps.Pro

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. Validation-ready: it comes with a qualification package you execute in your own environment.

See How It Works Request a Pilot

The Problem

Answers Your Team Already Has, Hard to Find

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.

Search hours spent finding answers the organisation already has, in SOPs and past deviations

Blank page every protocol, deviation report and CAPA starts again from an empty template

Scattered knowledge spread across shared drives, old reports and colleagues who have moved on

The Solution

An AI Co-Pilot Grounded in Your Documents

ComplianceGxP is an AI assistant grounded in your company’s own documentation. Your team asks questions in plain language and gets source-referenced answers and drafts in seconds.

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 a SHA-256 hash-chained, tamper-evident audit trail — designed to support your 21 CFR Part 11 and EU Annex 11 controls.

Private Knowledge Base

Your documents stay in your namespace. Per-client FAISS index, per-client API keys, never shared with other tenants.

Human Review Built In

Drafts are marked for review by a qualified person, and ComplianceGxP never writes to your QMS or other systems of record. The AI drafts; your team decides and signs.

GAMP5 Category 4 — Validation-Ready From Day One

ComplianceGxP is validation-ready, not validated. It comes with supplier specifications and SOPs, an installation qualification protocol (IQ, 16 test cases), an operational qualification protocol (OQ, 34 test cases) and templates for your URS, risk assessment and PQ. You validate it for your intended use in your environment, and I can support the execution.

GAMP5 Cat 4 21 CFR Part 11 EU Annex 11 ICH Q7 ICH Q10 EU AI Act ↗ GDPR

What's in the package, and how validation works → · EU AI Act position

Why ComplianceGxP

Built for GMP, Not Adapted to It

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
Managed for you on EU cloud hosting, or on your own infrastructure on request

Your Data

Your Documents Stay Yours

The first question every QA lead asks.

Isolated per client: your own namespace, vector index and API keys.
Not used to train AI models: answers are written by Anthropic’s Claude API, whose commercial terms exclude training on API data.
Every interaction is logged, including refused queries, in a tamper-evident audit trail.

Data flow, sub-processors and security controls →

Who’s Behind It

You Work With the Engineer Who Built It

Fits Your QMS

Complementary to Your QMS & CSV Tools

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.