Your Compliance Team Deserves Better Than Ctrl+F

Instant, sourced answers from your own SOPs, validation protocols and regulatory guidelines — built by a 25-year pharma automation veteran. GAMP5 Category 4 validated. MCP-ready.

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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.

30% of a QA specialist’s time lost to manual document search
3–6 weeks average delay on batch release caused by unresolved compliance queries
40% of audit findings trace back to missing or inaccessible documentation

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.

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4 Pharma Modes

QA, Deviation, CAPA, and Computer System Validation — each driven by purpose-built prompts that encode how a real validation engineer thinks.

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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.

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Private Knowledge Base

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

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MCP & SHARP Ready

Connect directly from Claude AI, Claude Code, and agent workflows over the Model Context Protocol. SHARP-compliant for healthcare agent interop.

GAMP5 Category 4 — Validated From Day One

ComplianceGxP ships with a full validation package: IQ-CGXP-001 (16 test cases), OQ-CGXP-001 (33 test cases with sign-off tables), and PQ-CGXP-001 templates ready to instantiate against your own document library.

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

Validation reports and evidence available under NDA.

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
  • Self-hosted via Docker, or fully managed on dedicated Swiss infrastructure

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.

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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.

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Investigate Deviations

Structured 5M root cause analysis grounded in your historical deviation library — faster than starting from a blank template.

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Draft CAPAs

Corrective and preventive actions with regulatory traceability, ready to paste into your QMS — not to write from scratch.

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Regulatory Gap Analysis

Map your SOPs against ICH, FDA, and EMA guidance to surface gaps before an auditor does.

Ready to stop searching and start finding?

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