Second Reviewer for Regulated QA Teams

Validation Protocol & Report
Mismatch Review in Minutes

A meticulous 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.

Reviews againstISO 13485:2016EU MDR 2017/745FDA 21 CFR 82021 CFR Part 11ISO 14971:2019
Fig. 01 — Real OutputMicrosoft Word · .docx

Findings appear as native Word comments at the exact location.

No separate panel, no separate report format. DocuReview attaches every finding as a Word comment directly in your file — at the exact sentence. What you show the auditor is what gets reviewed.

IQ_Protocol_Rev_C.docx
Input — Validation Protocol
MAJOR — §4.1.3: Acceptance criterion missing pass/fail threshold. Specify numeric limit per ISO 13485 §7.5.7.
Fig. 02 — Gap AnalysisComing Soon

See exactly which regulatory clauses your document set covers — and which it misses.

Upload your QMS documents, pick a standard. DocuReview checks every mandatory clause and returns MET / PARTIAL / GAP status with evidence references and required actions. In development — coming soon.

Gap Analysis — ISO 13485
§4.1.1METQMS scope documented in SOP-QMS-001
§7.3.2PARTIALDesign input records incomplete — revision history missing
§8.3.1GAPNo nonconformance procedure found in document set
The challenge

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.
Differentiators

Why not just paste into ChatGPT?

Purpose-built QA review logicISO 13485, EU MDR, FDA 21 CFR-aware review rules — 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.
Workflow

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.
Applications

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.
Plans

Simple pricing

Start free. Upgrade when you need more.

Free
$0
5 reviews/month, bring your own API key
Start free
Solo
$79/mo
50 reviews/month, API access included
Get Solo access
Pro
$149/mo
200 reviews/month, 25 sources, CSV export, audit trail
Get Pro access
Full pricing details →
Privacy & Security

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.
Questions

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 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 is an advisory second reviewer, not a regulatory authority.
Does it work on scanned PDFs?
No — scanned documents are images. DocuReview requires machine-readable (text-based) PDFs. Convert scanned documents with OCR first.
Can I use my own Anthropic API key?
Free tier users bring their own key (BYOK). It is encrypted locally and never sent to our servers. Solo and Pro plans include API access, so paid users have no key to set up.
What happens if I exceed my limit?
When you reach your monthly limit you can move up to a higher plan or wait for the next cycle. You can track your usage inside the app.