QARP AI Audit Assistant — Founding Users

🔬 Founding Users Program — Limited Spots

Your AI Audit Assistant.
From Prep to Report in Minutes.

QARP AI is a GxP-native intelligent assistant that guides clinical research auditors through every phase — powered by a large-context AI engine trained on your regulatory knowledge base.

Get Lifetime Access — €900 See How It Works ↓

2–3h

Audit Prep Saved

<60s

Report Draft Generated

100%

Source-Grounded Answers

ICH E6(R3)

& 21 CFR 11 Ready

The Problem

Auditing is exhausting — before you even start.

Every audit cycle eats hours of manual work that AI should handle.

2–3 days

📋 Pre-Audit Prep

Reviewing protocols, IBs, ICFs, TMF documents, risk signals. Building the audit program manually from scratch every time.

6–12 hrs

🔎 On-Site Audit

Juggling interview notes, document checks, and findings across topics — no system to guide what to check next or flag conflicts.

1–2 days

📝 Report Writing

Translating raw notes into structured findings, regulatory citations, root cause analysis and CAPA. All manual, all repetitive.

How It Works

Three phases. One intelligent assistant.

QARP AI accompanies the auditor from the first document upload to the signed final report.

📂 PLANNING & PREPARATION

Upload everything. QARP AI reads it all, finds the risks, builds your audit programme.

Document Upload

Protocol, IB, ICF, amendments (all versions)
Previous audit & inspection reports
TMF index, site SOPs, delegation logs
Regulatory submissions, safety reports, CAPAs
Drag-and-drop or browse — PDF, DOCX, XLSX
Batch upload: the more you share, the smarter QARP AI gets

AI Reads & Finds Patterns

Reads ALL documents simultaneously — cross-references inconsistencies
Identifies protocol deviations, missing re-consents, data gaps
Detects patterns across versions (e.g., amendment timelines vs. enrolment)
Generates a ranked Risk List: Critical / Major / Minor
Maps each risk to the relevant ICH / CFR / ISO paragraph
You can chat with QARP AI about any document, any risk, any question

Audit Type Intelligence

Detects and adapts to audit type:
Investigator Site (ISF) audit
Vendor / CRO audit
System / IT / CSV audit
Sponsor internal process audit
Tailors checklists and focus areas per site profile and phase
Pre-built question sets aligned to audit type and risk level

Generated Outputs

Complete Audit Programme — ready to export
Risk-based Checklist tailored to this specific audit
Interview Questions per role (PI, CRC, pharmacist, data manager)
Document request list for opening meeting
Focus areas ranked by risk signal strength

ICH E6(R3) ICH E8(R1) 21 CFR 312 EU CTR 536/2014 ISO 14155

✅ Ready before you arrive on site

Audit Programme
Risk Register
Tailored Checklist
Interview Guide
Document Request List

🔍 AUDIT CONDUCT — ON SITE

Live AI support throughout the audit day. Add notes, upload documents, build findings in real time.

On-Site Document Upload

Continue uploading documents during the audit
Lab records, pharmacy logs, source data printouts
Delegation log updates, training records
IP accountability logs, temperature records
QARP AI immediately analyses each new document and alerts on issues
Tells you what additional documents to request

Auditor Notes & Observations

Auditor Observations — free-text field, structured by topic
Interview Notes — what the PI / CRC said, verbatim or summary
Document Review Notes — page-level annotations
Photo / Evidence Log — attach supporting evidence per finding
All notes auto-tagged by audit area (consent, IP, safety, data)
Time-stamped audit trail preserved

Continuous AI Dialogue

Chat with QARP AI throughout the day
Ask: "What else should I check for this IP excursion?"
Ask: "Is this a GCP deviation or protocol deviation?"
QARP AI proactively flags contradictions between notes and documents
Suggests follow-up questions based on auditor observations
Guides what to cover before closing the audit

Preliminary Findings Builder

Findings log — Critical / Major / Minor classification
Each finding automatically mapped to ICH/CFR/ISO reference
AI suggests root cause hypothesis as you log findings
Builds running summary of the audit session
Exit meeting summary auto-generated from the day's notes
All data preserved — nothing lost between sessions

📋 End of audit day — already structured

Preliminary Findings Log
Structured Notes by Topic
Exit Meeting Summary
Evidence Index

📄 REPORTING

QARP AI assembles your report from your own template. You review, refine, and sign.

Your Template, Your Report

Upload any client or company report template (DOCX or PDF)
QARP AI maps all findings and notes to your template structure
Maintains your section headings, numbering, and formatting style
Generates draft from the complete audit record in seconds
No data left out — findings, notes, observations all included

Full Report Sections Generated

Executive Summary — scope, date, site, overall rating
Summary Narrative — audit story in professional prose
Observations Table — all findings with ref, classification, evidence
Root Cause Analysis — 5 Why per critical and major finding
Recommended Corrective Actions — specific, measurable, time-bound
Regulatory Citations — exact paragraph references per finding
Follow-up Actions — trackable action list with owners

Human Review — Always Required

QARP AI generates a draft — the auditor always reviews and approves
Inline edit mode: accept, revise, or delete any section
AI explains its reasoning for every finding classification
Track-changes view to see what AI wrote vs. what you changed
Final report only exports after auditor sign-off
All outputs are professional drafts — not final regulatory submissions

Export & Delivery

Export as DOCX (editable) or PDF
Preserves client template formatting exactly
Appendix: evidence log, document list, AI chat summary
21 CFR Part 11 compliant audit trail available on request
Secure link sharing for review cycle (no email attachments)

📝 Report sections always included

Executive Summary
Narrative
Observations Table
Root Cause (5 Why)
Recommended Actions
Regulatory Refs
Action List

Architecture

Brain + Hands. Not just a chatbot.

QARP AI is the domain brain. The orchestrator coordinates agents, parses documents, and builds the report.

System Architecture

🧠

QARP AI — The Brain

Large-context AI engine (1M tokens)
ICH E6(R3), 21 CFR 11/50/312,
EU CTR 536/2014, ISO 14155,
your SOPs & checklists

⇄

📂 Document Parser AgentUploads → structured data, risk extraction, cross-document pattern detection

🔍 Compliance MapperFindings → ICH/CFR/ISO exact paragraph references

📝 Report Writer AgentAll data → structured DOCX/PDF matching your template

💡 Recommendation AgentRoot cause (5 Why) + specific corrective actions

Large Context AI (1M ctx) LangGraph Orchestrator GAMP 5 Compliant 21 CFR Part 11 Audit Trail GDPR / EU Data Residency EEA Server Infrastructure

How It Works — Live

Three phases. One intelligent assistant.

Each phase is fully guided by QARP AI — from document upload to signed report. Click a phase to explore what happens and see the interface.

⏱ 2–3 days → 30 min

Upload documents. QARP AI builds your audit program.

Drop in the Protocol, IB, ICF, previous audit reports, and risk assessments. The Document Parser Agent extracts risk signals, maps regulatory requirements, and generates a fully tailored, risk-ranked audit program — before you step on-site.

1Upload Protocol, IB, ICF, previous reports

2AI parses documents, detects risk signals

3Auto-generates audit program + checklist

4Review, customise, and go on-site

Protocol (latest version), Investigator Brochure, all ICF versions, previous audit/inspection reports, site risk assessment, delegation log, and any site SOPs you have. Supported formats: PDF, DOCX, XLSX.

Typically 2–5 minutes for a standard protocol + IB + ICF set. You receive a notification when the audit program is ready.

Yes — this is a Founding User benefit. During onboarding, you send your SOPs and templates. They are loaded into your personal QARP AI knowledge base and applied to all future audits.

Only de-identified documents should be uploaded. QARP AI is designed for audit preparation materials (protocols, IBs, checklists) — not source documents with patient PII/PHI. All data is stored on EU infrastructure.

QARP AI — Audit Preparation · Site: Central Hospital · Protocol: QRP-2025-01

Risk Register — Auto-Generated from Documents

Critical Risk

ICF Version Control — 3 amendment versions detectedProtocol v1, v2, v3 uploaded. Amendment effective dates vs enrolment dates require verification. Ref: ICH E6(R3) §4.8.

Major Risk

IP Storage — No temperature monitoring SOP found in TMFIB lists cold-chain requirement 2–8°C. Site SOP not uploaded. Ref: ICH E6(R3) §5.13.

Focus Area

Training Records — GCP training dates not confirmedDelegation log references 4 staff. Training certificates not in TMF index. Ref: ICH E6(R3) §4.1.

QARP AI Chat

QARP AI

I've analysed 6 uploaded documents. Audit type detected: Investigator Site (ISF). 1 critical risk signal found. Shall I generate the audit programme and interview questions?

Yes — ISF audit, Phase II oncology

QARP AI

✅ Audit Programme ready. 4 topic areas, 23 checklist items, 12 interview questions for PI/CRC/pharmacist. ICF version control flagged as priority #1.

📱 Mobile-ready · Real-time

Log findings live. QARP AI maps every one to regulation — instantly.

During the on-site visit, QARP AI is your co-auditor. Log findings by topic, record interview notes and observations, upload documents on-site, and chat with QARP AI to ask what to check next — all from your phone or laptop.

1Open your session on phone or laptop

2Chat with QARP AI — ask anything in real time

3Log findings — AI classifies and cites regulations

4Log interview notes, observations, issue findings with recommendations

No. Your QARP AI session is fully private. Site staff have no access to your findings log, AI chat, or uploaded documents. Sessions are password-protected.

Always override. Every AI suggestion is fully editable. Professional judgement is always yours — QARP AI is a starting point, not a final verdict.

The current version requires connection for AI features. Offline findings logging is planned for Q3 2026. Workaround: log notes locally, sync when connected.

Yes. Every action is timestamped in a 21 CFR Part 11-compliant audit trail. You can export the full session log as CSV or PDF at any time.

QARP AI — Audit Conduct · Site: Central Hospital · Protocol: QRP-2025-01

Findings Log — Live

Critical

Informed Consent — Missing re-consent for protocol amendment v35 subjects enrolled after amendment effective date without updated ICF. Ref: ICH E6(R3) §4.8.2, 21 CFR 50.25.

Major

IP — Temperature excursion not documentedIP storage log shows gap Apr 3–5. No deviation report filed. Ref: ICH E6(R3) §5.13.

Minor

Training Records — 2 staff with expired GCP certificatesCRC and sub-investigator. Ref: ICH E6(R3) §4.1.

QARP AI Chat

QARP AI

Based on the missing re-consent finding, check also: randomization dates vs amendment effective date, and delegation log for PI signature. Want me to draft a finding recommendation for your report?

Yes, draft a recommendation for the ICF finding

QARP AI

Root Cause (suggested): No SOP trigger for amendment-driven re-consent review.
Recommended action: Obtain re-consent from affected subjects; update site re-consent SOP; retrain staff. Note: CAPA is issued by the auditee in response to this finding.

⚡ 1–2 days → < 60 seconds

From session notes to full draft report. In under a minute.

The Report Writer Agent assembles everything from your session — findings, severity ratings, regulatory citations, root cause analyses, and recommended corrective actions — into a structured report. Select your template, generate, review, and export as DOCX or PDF.

1Select template (QARP standard or your own DOCX)

2Click Generate — full draft in < 60 seconds

3Review and edit in built-in editor

4Export DOCX / PDF — sign off — deliver

Yes. Upload a DOCX template with placeholders and QARP AI will populate it. During founding user onboarding, send your template to maxim.bunimovich@theqarp.com and we configure it for you.

After your review and sign-off, yes. The report is your professional document — QARP AI drafts it, but you sign it. Professional responsibility remains yours, as with any audit report.

QARP AI drafts recommended corrective actions for the auditor to include in the report — not CAPAs (which are the auditee's responsibility). Accuracy depends on your finding descriptions. Always review before including in the final report.

Yes. Every edit, generation event, and sign-off is timestamped in a 21 CFR Part 11-compliant log including QARP AI version, document inputs used, and generation timestamp.

QARP AI — Report Generation · Site: Central Hospital · Protocol: QRP-2025-01

Draft Report — Generated from Session Data

Executive Summary

Audit conducted 29 Apr 2026 at Central Hospital. Audit type: Investigator Site (ISF). Overall rating: Requires Corrective Action. 1 Critical, 1 Major, 1 Minor finding identified.

Findings Table

Ref	Finding	Class
F-01	Missing ICF re-consent (5 subjects)	Critical
F-02	IP temperature excursion undocumented	Major
F-03	2 expired GCP training certificates	Minor

QARP AI Chat

QARP AI

Report draft generated in 43 seconds. All 3 findings included with regulatory citations and recommended actions. Want me to add a Positive Observations section?

Yes, add observations for IP storage process

QARP AI

✅ Added: "Site maintains a well-organised IP accountability log and appropriate storage area. Temperature excursion noted was isolated and the underlying process is sound."

Founding Users Deal

Get in before launch. Pay once, use forever.

Early access starts 12 May 2026. Spots are strictly limited.

✗ Fully Booked

€700

Early Bird · First 5 spots

♾️Lifetime access
🧪Early access May 12
🧠Custom Knowledge Base
📞Onboarding call
📄Founding User Agreement

SOLD OUT

✦ Open — Limited Spots

€900 one-time

Individual · 1 user · Regular: ~~€97/month~~

Spots taken8 / 20

♾️Lifetime access — all future updates included
🧪Early tester access — May 12, before public release
🧠Custom Knowledge Base — your SOPs & templates
📞Onboarding call with the founder + priority support
🗳️Product Advisory Group — shape the roadmap
📄Founding User Agreement — legally protects your data & access

💳 Pay by Card (Stripe) 🏦 Bank Transfer (SEPA/SWIFT)

By proceeding you agree to the Founding User Agreement · Questions?

🏢 Corporate

€1,500 one-time

3 named users · 1 legal entity

♾️Lifetime access for 3 named users
🧠Shared Knowledge Base — team SOPs & templates
📞Team onboarding session + dedicated support
🗳️Product Advisory Group — priority feature voting
📄Corporate Agreement with DPA & data processing schedule
🔄Named users can be substituted on written request

✉️ Request Corporate Invoice 🏦 Bank Transfer (SEPA/SWIFT)

View Founding User Agreement

Bank Transfer Details

Pay by SEPA or SWIFT Transfer

After transfer, send confirmation to maxim.bunimovich@theqarp.com — access activated within 24 hours.

RecipientTHE QARP ACADEMY S.L.

Registration №B19913078

AddressCarrer Lluís I Companys, 08860 Castelldefels, Spain

IBAN (EUR)ES66 1583 0001 1793 4976 6470

BIC / SWIFTREVOESM2

Intermediary BIC (non-EEA)CHASDEFX

BankRevolut Bank UAB, Branch in Spain

Bank AddressC/ Príncipe de Vergara 132, 4ª planta, 28002 Madrid

AmountEUR 900 (Individual) · EUR 1,500 (Corporate)

ReferenceFOUNDING-USER-[YOUR NAME]

Founding Testers

The first people shaping QARP AI.

Maxim B.

GCP Auditor · Founder

Your spot

Available

Your spot

Available

Your spot

Available

FAQ

Questions & Answers

What is "lifetime access" exactly?

You pay €900 once. You get full access to QARP AI Audit Assistant — all current features and all future updates — for as long as the platform exists. No monthly fees. This is locked in the Founding User Agreement.

What happened to the €700 Early Bird price?

The first 5 Early Bird spots at €700 are fully booked. The current Founding User price is €900 (Individual) or €1,500 (Corporate — 3 users). Both include lifetime access and all the same benefits.

What types of audits can QARP AI support?

QARP AI supports Investigator Site (ISF) audits, Vendor / CRO audits, System / CSV / IT audits, and sponsor internal process audits. It detects the audit type from your uploaded documents and tailors checklists, questions, and focus areas accordingly. All output is aligned to ICH E6(R3), 21 CFR, EU CTR 536/2014, and ISO 14155.

Can I use my own report template?

Yes. Upload your DOCX or PDF report template and QARP AI will generate the draft using your structure, section headings, and numbering. All findings, narrative, root cause, recommended actions, and regulatory references are mapped to your template. The auditor always reviews and approves before export.

When do I get access?

Early access begins 12 May 2026. After payment confirmation, you will receive an onboarding email within 24 hours with account setup instructions and a calendar invite for your onboarding call with the founder.

Is my patient/trial data safe?

Yes. No patient-identifiable data (PII/PHI) is ever sent to external AI models. The system is designed for anonymised or de-identified audit documents. All data is stored on EU-based infrastructure (EEA). See full confidentiality terms in the Founding User Agreement.

What regulatory frameworks does QARP AI cover?

ICH E6(R3) GCP, ICH E8(R1), 21 CFR Parts 11/50/54/56/312, EU Clinical Trials Regulation 536/2014, ISO 14155:2020 (medical devices), EAEU GCP, GAMP 5. The knowledge base is continuously updated.

Can I use it on mobile during an audit?

Yes. The web application is fully mobile-responsive. On-site you can add notes, upload documents, and chat with QARP AI from your phone or tablet. A dedicated mobile app is in development (iOS/Android, Q3 2026).

What if the product doesn't meet my expectations?

If after your first 30 days of testing you are not satisfied, contact maxim.bunimovich@theqarp.com for a full refund. This is stated in the Founding User Agreement.

What is the Corporate plan?

The Corporate Founding User plan (€1,500 one-time) provides lifetime access for up to 3 named users within a single legal entity, a shared team Knowledge Base, team onboarding, and a corporate agreement with GDPR Data Processing Schedule. Named users can be substituted on written request.

What is THE QARP ACADEMY SL?

THE QARP ACADEMY S.L. is a Spanish limited company (B19913078), headquartered in Castelldefels, Spain. Director: Maxim Bunimovich. Specialises in GxP training, clinical research quality, and AI-powered compliance tools.

Ready to audit smarter?

Join the auditors who will define how AI changes clinical research compliance.

Individual Access — €900 Corporate (3 users) — €1,500

Questions? maxim.bunimovich@theqarp.com

Your AI Audit Assistant.From Prep to Report in Minutes.

Auditing is exhausting — before you even start.

📋 Pre-Audit Prep

🔎 On-Site Audit

📝 Report Writing

Three phases. One intelligent assistant.

📂 PLANNING & PREPARATION

Document Upload

AI Reads & Finds Patterns

Audit Type Intelligence

Generated Outputs

🔍 AUDIT CONDUCT — ON SITE

On-Site Document Upload

Auditor Notes & Observations

Continuous AI Dialogue

Preliminary Findings Builder

📄 REPORTING

Your Template, Your Report

Full Report Sections Generated

Human Review — Always Required

Export & Delivery

Brain + Hands. Not just a chatbot.

QARP AI — The Brain

Three phases. One intelligent assistant.

Upload documents. QARP AI builds your audit program.

Log findings live. QARP AI maps every one to regulation — instantly.

From session notes to full draft report. In under a minute.

Get in before launch. Pay once, use forever.

Pay by SEPA or SWIFT Transfer

The first people shaping QARP AI.

Questions & Answers

Ready to audit smarter?

Your AI Audit Assistant.
From Prep to Report in Minutes.