AI-Assisted Second Reviewer

Validation Protocol & Report
Mismatch Review in Minutes

AI-assisted second reviewer for medical device QA. ISO 13485, EU MDR, FDA 21 CFR. Catch acceptance criteria mismatches, traceability gaps, and missing evidence before your auditor does.

Start free — 5 reviews/month, no cardSee plans →

No signup. No credit card. Document content goes only to Anthropic's API — never stored on our servers.

The problem we solve

⏱
Hours of manual checking
Hand-checking an 80-page validation protocol against its report takes a full day — and human reviewers miss subtle mismatches.
🔍
Auditors catch what you missed
Acceptance criteria in the protocol that contradict the report. A wrong revision reference. Missing evidence for a tested requirement. All audit findings that could have been caught first.
📋
Not just body text
Headers, footers, revision history tables, signature blocks, table cells — all ignored by a quick scroll review. We scan everything.

Why not just paste into ChatGPT?

✓
Pre-built QA promptsISO 13485, EU MDR, FDA 21 CFR-aware review logic — not generic text analysis.
✓
Multi-source libraryCite your own SOPs, IQ/OQ/PQ protocols alongside regulatory standards.
✓
Word comment injectionFindings appear as native Word comments at the exact correct location in your document.
✓
Deterministic 3-level severityMAJOR, MINOR, OFI — every finding categorized consistently, not guessed.
✓
Full document coverageBody, headers, footers, tables, captions, revision history, signature blocks — all scanned.
✓
Reviewable findings panelAccept, reject, or defer each finding before export. Only accepted findings go into the final DOCX.

How it works

1
Upload your document
Drop a .docx, PDF, or .txt file. Add source documents (SOPs, standards, protocols) to the source library.
2
Pick standards and mode
Choose ISO 13485, EU MDR, FDA 21 CFR, or all three. Select Quick Scan or Deep QA Review.
3
Review findings, export Word
Accept or reject each finding in the panel. Download the reviewed .docx with Word comments at exact locations.

Use cases

📄
Protocol ↔ Report Consistency
The primary use case. Cross-check every acceptance criterion, sample size, and conclusion between your validation protocol and its execution report.
📋
SOP vs Execution Review
Verify that procedure steps were followed as documented. Flag deviations or missing evidence.
⚠
Risk Assessment Review
Check FMEA completeness: severity/probability scoring, risk mitigation traceability, residual risk documentation.
🔗
URS ↔ IQ/OQ/PQ Traceability
Every user requirement mapped to at least one qualification test, every test traced back to a requirement. No orphans.

Simple pricing

Start free. Upgrade when you need more.

Free
$0
5 reviews/month, BYOK
Start free
Solo
$49/mo
Unlimited reviews, managed API
Upgrade to Solo
Pro
$149/mo
25 sources, CSV export, audit trail
Upgrade to Pro
Full pricing details →

Data handling

🔒Document content is sent only to Anthropic's API to generate findings — never to any server we own.
🔒Anthropic does not train on API data (zero-data-retention policy by default).
🔒Nothing is stored on our servers. Review metadata stays in your browser only.
🔒You can clear all local data anytime from Settings.
🔒Free tier: your Anthropic API key is encrypted in your browser with a per-device key and never leaves your machine.

FAQ

What file types are supported?
.docx (Word), PDF (text-based — not scanned), and .txt files up to 10 MB.
Is this a validated QMS?
No. DocuReview AI is an advisory review tool. It does not replace a validated Quality Management System. All findings must be reviewed by a qualified QA professional.
Who is liable for missed findings?
The final compliance assessment and responsibility rest with the user and their QA team. DocuReview AI is an advisory second reviewer, not a regulatory authority.
Does it work on scanned PDFs?
No — scanned documents are images. DocuReview AI requires machine-readable (text-based) PDFs. Convert scanned documents with OCR first.
Can I use my own Anthropic API key?
Yes — free tier users bring their own key (BYOK). It is encrypted locally and never sent to our servers. Solo and Pro users get a managed key.