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AI-Powered Decision Support · For Regulated Industries

The QARP Intelligence Platform — AI-Powered Decision Support for Clinical Quality, Vendor Oversight and Inspection Readiness

Purpose-built for QA, CSV/IT Validation, Clinical Operations and Sponsor Oversight teams in pharma, biotech, and CROs. Not a generic chatbot — a regulated GxP methodology engine.

Request Enterprise Demo → Start Free Trial Download Validation Pack

ICH GCP E6(R3)-aligned GAMP 5-aware 21 CFR Part 11 principles Human-in-the-loop by design Anonymization on all plans SOP / RAG-ready

Who it is for

Built for five teams that own quality and oversight

Each role gets workflows that match the questions an inspector will actually ask.

QA / CQA Managers

Inconsistent CAPA quality and nonconformity language across teams and studies.

Standardise root cause analysis and CAPA format across all studies
Generate inspection-ready audit findings in O.S.E.C. format
Track CAPA status, training completion, and risk register outputs

See CAPA Workflow →

CSV

CSV / IT Validation

AI systems deployed without validation documentation — regulatory exposure.

Choose Cloud, Hybrid (your servers + our AI), or fully On-Premise deployment
GAMP 5 validation package available (IQ, OQ, PQ, URS, Risk Assessment)
Anonymization layer keeps all data in your environment (Hybrid/On-Prem)

Download Validation Kit →

Heads of Clinical Operations

Inconsistent inspection readiness across sites and monitors.

Build RBQM Risk Registers from protocol in under 1 hour
Generate ICF version matrices, training gap analyses, and question banks pre-inspection
Standardise monitoring deviation summaries across all CRAs

See Audit Prep Demo →

CRO

CROs and Clinical Vendors

Sponsor qualification audits require evidence of QMS maturity — hard to demonstrate at scale.

Prepare structured vendor qualification audit plans and document request lists
Generate O.S.E.C. findings consistently across all auditors
Demonstrate CAPA quality and RCA depth to any sponsor

See CRO Use Case →

Pharma / Biotech Sponsor Teams

Sponsor oversight per ICH E6(R3) §3.9 requires documented vendor oversight evidence.

Qualify CROs, labs, and ePRO/eCOA vendors with structured audit tooling
Review vendor CAPA responses for RCA quality and completeness
Build and maintain vendor risk registers with scoring

Request Enterprise Demo →

Not sure which fits?

Book a 30-min scoping call

We'll map your workflows against the right deployment and pricing model.

Book Scoping Call

How it works

Not a generic chatbot. A GxP methodology engine.

Every workflow is built on real audit findings, ICH E6(R3) requirements, and EMA guidance — not general AI prompting.

GxP AI Assistant

Online

Write CAPA for Finding MAJ-2025-012: missing delegation log update after PI change, Study XYZ-001, UK

Phase 1 — Clarification

Before I proceed, I need to clarify:
1. Was this a scheduled or unscheduled PI change?
2. Was the delegation log update missed entirely or delayed?
3. Any patient safety impact identified?

Scheduled PI change. Log update was delayed by 3 weeks. No safety impact, but sponsor notified.

Phase 2 — Root Cause Analysis

5 Whys Analysis:
Why 1: Delegation log not updated → No automated reminder
Why 2: No reminder system → SOP lacks trigger mechanism
Why 3: SOP gap → Process written before PI turnover became frequent
Why 4: No oversight mechanism → QA review of PI changes not part of process
Why 5: No QA review → Site relied on PI self-reporting for delegation updates

Root Cause: SOP-GOV-003 lacks PI transition checklist with mandatory delegation log update trigger.

Phase 3 — Full CAPA

Correction: Update delegation log immediately for Study XYZ-001
Corrective Action: Revise SOP-GOV-003 to include PI transition checklist
Preventive Action: Implement automated delegation log reminders in CTMS
Effectiveness Check: Audit next 5 PI changes for delegation log compliance

CAPA Score: 11 / 12 — Strong

Validated modes

Five working tools, one platform

Each module solves a concrete daily QA or ClinOps task — designed for regulated work, not generic AI prompting.

CAPA Review

Dual-mode review of deviations and CAPA responses with structured RCA scoring.

Root-cause analysis depth check
CAPA adequacy scoring
Inspection-ready output

CAPA Generate

3-phase validated CAPA generation from free-text deviation input — Phase 1 → 2 → 3.

Phase-gated workflow
Standardised format
Audit-trail logging

Audit Finding Generator

Structure observations in O.S.E.C. format consistently across all auditors and studies.

O.S.E.C. format enforcement
Severity classification
Cross-auditor consistency

RBQM / CTQF Assistant

Upload a study protocol. The system extracts Critical Quality Factors, builds a scored Risk Register with monitoring triggers, and exports it ready for your Monitoring Plan.

Protocol-to-CQF extraction
Risk Register with probability and impact scoring
Monitoring trigger recommendations
E6(R3)-aligned output

Audit Preparation Module

Upload your study document package before a site visit or sponsor audit. The system generates:

Deviation summary (chronological, by severity)
ICF version matrix (participant × version × date vs screening and EC approval)
Training gap analysis
Inspector question bank tailored to your protocol and findings

Full release: 01 September 2026 · Audit Observation mode available now

Free Prompt (GxP-aware)

Open prompt for ad-hoc QA/GCP questions — with automatic anonymization and decision-support logging.

GxP-aware system prompt
Session-only retention
Safe alternative to generic AI

Privacy by design

Automatic anonymization — on every plan

Built for regulated industries. Every design choice reflects GxP thinking — not just AI with a compliance label.

Decision Support Only

QARP is a decision-support system. Outputs are reviewed and signed off by qualified humans — never auto-executed.

GxP / GAMP-Aware

Designed in line with GAMP 5, ICH GCP E6(R3) and 21 CFR Part 11 principles. Formal compliance determination rests with the deploying organisation.

Automatic Anonymization

Patient and personal data are anonymised before reaching the AI engine. Re-identification happens locally, after review.

Continuous Monitoring

Every action is logged. Audit trail, change history and prompt versions are retained for inspection.

Before / After anonymization — example

Before

Patient: John Smith
Site: London Royal Hospital
PI: Dr. Sarah Johnson
Study: XYZ-001-UK

After

Patient: [SUBJECT]
Site: [SITE-001]
PI: [INVESTIGATOR]
Study: [STUDY-ID]

For Hybrid and On-Premise deployments, the anonymization layer runs locally on your infrastructure. No study data, patient identifiers, or sponsor-confidential information ever leaves your environment.

Deployment

Choose the deployment model that matches your data governance requirements

	Individual	Team Cloud	Hybrid SOP Workspace	On-Premise
Best for	Independent auditors, consultants, CRAs	QA / ClinOps teams, fast start	Teams needing AI connected to their own SOPs	Strict data control, sponsor/regulatory requirements
Data model	Cloud	Isolated cloud workspace	Your SOP server + QARP AI via API	Fully local — nothing leaves your network
IT involvement	None	None	Moderate	Full deployment
Anonymization	✓ All plans	✓	✓ Local layer	✓ Local layer
Validation package	Platform controls	Vendor docs available	Lightweight (URS, IQ, RA)	Full GAMP 5 (IQ, OQ, PQ, URS, RA)
Deployment time	Instant	5 working days	6–8 weeks	10–14 weeks

Not sure which model fits? Book a 30-minute architecture and scoping call — no commitment required.

Book Scoping Call

Pricing

Plans for individuals, teams and enterprises

Switch the toggle to see plans for your audience. Team and enterprise pricing is confirmed in a short scoping call.

Common questions from compliance and IT teams

Is my data used to train your AI?

No. Documents uploaded to the platform are processed in-session only and are not used for model training.

Where is data stored?

Individual and Team Cloud plans use EU-based isolated cloud infrastructure with session-only retention. Hybrid and On-Premise deployments keep all data within your own environment.

Is the platform 21 CFR Part 11 compliant?

The platform is designed in line with 21 CFR Part 11 principles — including audit trails, access controls, and unique user identification. Formal compliance determination rests with the deploying organisation.

What validation documentation is available?

Vendor documentation is available for all deployments. A full GAMP 5 package (IQ, OQ, PQ, URS, Risk Assessment) is included with On-Premise deployment. A lightweight qualification pack is available for Hybrid.

Can this run on our own servers?

Yes. On-Premise deployment includes local AI model installation, full platform stack, and GAMP 5 validation package. A no-cost technical scoping session is available before any commitment.

Is anonymization included in the free trial?

Yes. Automatic document anonymization is available on all plans including the 7-day free trial.

Get started

Pick the path that fits — both lead to a live workflow

Enterprise

See it with your own documents

Upload 3 SOPs and run a live demo in 15 minutes with your actual workflows.

Request Enterprise Demo

Individual

Try it yourself today

Free 7-day trial. No credit card required. Full access to all workflows.

Start Free Trial

Questions? Write directly — maxim.bunimovich@theqarp.com