GxP Prep AI generates complete, citation-verified audit packages from your study documents — with zero document retention, full encryption in transit, and confidence tags on every claim. Your documents are processed and discarded. Your audit package is yours alone.
Your documents processed in memory. Never stored. Never retained. You stay in control.
You have a clinical site audit in 10 days. The sponsor sent the protocol, the clinical monitoring plan, and the investigator's brochure. Before you walk in the door, you need a customized audit checklist, targeted interview questions, a risk assessment tied to the right regulatory sections, and a document request list. That prep work takes 4 to 8 hours — time you could spend auditing, writing reports, or winning your next engagement.
Now multiply that by every audit on your calendar.
If you're billing at $150 to $250 per hour, every audit prep cycle costs you $600 to $2,000 in time. Over 20 audits a year, that's $12,000 to $40,000 in capacity you can't recover.
Audit prep is the bottleneck that compresses everything else in your practice.
The problem isn't just finding information. It's turning it into a study-specific, regulation-accurate audit package — without exposing your client's confidential documents in the process.
GxP Prep AI is purpose-built for independent GxP auditors and consultants. Upload your study documents, select your regulatory framework, and receive a formatted, citation-verified audit package — ready to use or ready to refine.
Upload your study documents — protocol, CMP, investigator's brochure. PDF, Word, or text. Your file is encrypted in transit and processed entirely in server memory.
Choose your regulatory framework — ICH GCP, FDA GCP+GLP, OECD GLP, or let the AI choose. Multi-framework coverage available.
Receive your complete audit package: customized checklist, targeted interview questions, risk assessment with regulatory citations, and document request list. Every citation is verified against regulatory source text.
Your audit package is delivered as a formatted Word document. Once delivered, your uploaded document and all associated data are discarded from our servers. Nothing is retained.
You stay in control. We handle the heavy lifting — and then we forget everything.
65% of regulatory professionals distrust AI-generated compliance documents. They're right to be cautious. This is what GxP Prep AI does that generic tools don't.
Every regulatory reference is cross-checked against our Regulatory Knowledge Graph — a verified database of ICH E6(R3), 21 CFR Parts 11/50/58/312, and OECD GLP source texts. Generic AI generates citations. We verify them.
Every claim carries a visible tag: Verified (matched to regulatory source text), Inference (logically derived), or Unverified (flagged for your review). You never guess what's confirmed and what isn't.
Your audit package is generated from your actual study documents. Checklist items, interview questions, and risk areas are tailored to the specific study design, endpoints, population, and regulatory scope.
The platform maps cross-references between regulatory frameworks automatically. Where ICH E6(R3) and FDA regulations overlap, diverge, or supplement each other — it's surfaced in your output.
Your output is a professionally formatted Word document with structured sections, color-coded tags, and a validation summary. No copy-pasting from chat windows. No reformatting.
Your documents are processed entirely in server memory. No database storage, no file system writes, no backups. When your session completes, the memory is released. This is not a data retention policy — it is an architectural decision.
We publish the complete lifecycle of your document — every step from upload to deletion, every third-party service involved, and exactly what each one sees. Visit our Security & Data Handling page for the full architecture.
Phase III Clinical Site GCP Audit — Preparation Workflow
| Preparation Task | Manual Preparation | With GxP Prep AI |
|---|---|---|
| Review protocol & identify focus areas | 45-90 min | Automated during upload |
| Build study-specific audit checklist | 60-120 min | Generated in package |
| Draft interview questions | 45-90 min | Generated in package |
| Cross-reference applicable regulations | 30-60 min | Multi-framework auto-mapped |
| Risk assessment tied to study design | 30-60 min | Generated with risk coding |
| Compile document request list | 20-40 min | Generated in package |
| Format into working audit documents | 30-60 min | Delivered as formatted .docx |
| Total Preparation Time | 4-8 hours | Under 30 minutes |
*Includes AI generation time plus your professional review of the output.
20 audits/year x 6 hours prep = 120 hours
At $175/hour = $21,000 in prep time annually
Time not spent on billable work, reports, or new clients.
20 audits/year x 30 min review = 10 hours
110 hours recovered = $19,250 in freed capacity
At $99/mo, the platform pays for itself with a single audit.
You handle proprietary protocols, unpublished safety data, and sponsor-confidential monitoring plans. We designed GxP Prep AI's architecture around this reality — not as an afterthought, but as a core design constraint.
Your documents are processed in memory and discarded. No database. No file storage. No backups. When your audit package is delivered, the memory is released. Your documents cannot be retrieved because they no longer exist anywhere on our infrastructure.
| Stage | What Happens | What Does NOT Happen |
|---|---|---|
| Upload | Document encrypted in transit (TLS 1.2+) and received in server memory | Document is never written to any database, disk, or storage |
| Parsing | Text extracted from document entirely in RAM | No copy of the file is created anywhere |
| AI Processing | Extracted text sent to Anthropic's Claude API (encrypted). Anthropic does not retain inputs or use them for training. | We are transparent: text does transit Anthropic's infrastructure during this step |
| Validation | AI output checked against our Regulatory Knowledge Graph | Your original document is not involved in this step |
| Delivery | Formatted .docx generated in memory and streamed to your browser | Output is not stored on our servers |
| After Delivery | Server memory released. All data ceases to exist. | Nothing to retrieve, export, or leak — it's gone |
Because we do not store your documents, a breach of our infrastructure would not expose your study documents. An attacker accessing our database would find email addresses, subscription tiers, and usage counts. They would not find any study documents, audit packages, or document-related data — because none is stored.
We don't ask you to trust a policy. We designed an architecture where there's nothing to leak.
Every regulatory reference links back to verified source text in our regulatory database.
The [Verified] / [Inference] / [Unverified] tagging system tells you where the AI is confident and where you need your judgment.
You are the auditor. The platform is your assistant. It accelerates preparation, not replaces judgment.
In-memory processing only. No storage, no backups, no retrieval possible after delivery.
We publish exactly what happens to your data at every stage, including which third-party services are involved.
Hosting (Vercel) and database (Supabase) providers are SOC 2 Type 2 certified. Payment processing by Stripe (PCI DSS Level 1). All data encrypted in transit.
We don't ask you to trust the AI. We give you the evidence to verify it yourself. And we don't ask you to trust our data handling. We show you the architecture.
One audit package saved pays for a month of Starter. Zero document retention included at every tier.
Your next audit is on the calendar. Your prep time doesn't have to be.
Built by auditors, for auditors. Verified citations. Transparent data handling. Your call, always.