AI Compliance Engines

Upload a document. Get a structured compliance report. Same quality as a $300/hr consultant, delivered in minutes.

PDF, DOCX, Plain Text JSON or DOCX Reports REST API & MCP 3 Free Runs/Month
1

Upload Your Document

SOP, label, deviation report, audit checklist, supplier questionnaire — any quality document.

2

AI Analyzes Against Standards

Cross-referenced against FDA regulations, ISO standards, and cGMP requirements with deterministic scoring.

3

Get Structured Report

Findings with severity scores, regulation citations, recommended corrections, and full provenance.

$8/run

SOP Gap Analysis

Identify missing procedures and documentation gaps against quality standards.

Standards Covered

ISO 9001 ISO 13485 21 CFR Part 211

Input

SOP document (PDF, DOCX, or text) + target standard(s)

Output

  • Gap inventory with priority rankings
  • Severity scores per finding
  • Remediation recommendations
  • Clause-by-clause citations
$5/run

Label Review

FDA compliance review for product labels across regulated product categories.

Products Covered

OTC Drugs Supplements Medical Devices Cosmetics

Input

Label image (PNG, JPG) or document (PDF, DOCX) + product type

Output

  • Missing required elements
  • Unauthorized claim detection
  • 21 CFR regulation citations
  • Recommended corrections
$15/run

CAPA Draft

AI-drafted Corrective & Preventive Action plans from deviation reports.

Frameworks

All QMS Frameworks FDA ISO

Input

Deviation report, nonconformance record, or complaint

Output

  • Root cause analysis
  • Corrective action plan
  • Preventive action plan
  • Effectiveness criteria
$12/run

Audit Readiness

Pre-audit assessment with readiness scoring and prioritized prep actions.

Standards

ISO 9001 ISO 13485 FDA

Input

QMS documentation package or self-assessment checklist

Output

  • Readiness score by audit area
  • High-risk flags
  • Prioritized preparation actions
  • Effort estimates
$3/run

Deviation Triage

Fast classification of deviations by severity with risk evaluation.

Classification

Critical Major Minor

Input

Deviation description or incident report

Output

  • Severity classification with rationale
  • Scope assessment
  • Response pathway recommendation
  • Regulatory reporting assessment
$5/run

Change Control Impact

Impact assessment for changes to materials, processes, equipment, or procedures.

Impact Areas

Quality Regulatory Validation Supply Chain

Input

Change request description + affected systems

Output

  • Impact classification
  • Approval pathway recommendation
  • Verification requirements
  • Training & documentation updates
$10/run

Supplier Qualification

Risk-based assessment of supplier QMS maturity and compliance.

Supplier Types

Raw Materials Components Contract Mfg

Input

Supplier questionnaire, audit report, or capability data

Output

  • QMS maturity assessment
  • Risk classification
  • Approve/Conditional/Reject decision
  • Monitoring recommendations

Integration Options

Use our engines however works best for your team.

REST API

Direct integration via our REST API. OpenAPI docs included. Perfect for custom workflows and automation.

MCP Server

Use directly from Claude Desktop, Cursor, or any MCP-compatible AI assistant. Compliance in your workflow.

AI Marketplaces

Available on Anthropic Connectors, MCPize, Apify, and more. Use through your existing AI tools.

Start Using AI Compliance Engines Today

3 free runs per engine per month. No credit card required.

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