Audit-Defensible AI for Quality & Regulatory Professionals
Medical device and general supplier quality — FDA enforcement data, multi-standard mapping, and ALCOA+ audit trails on every AI output.
Trust signals
Model AI Council
OpenAI · Anthropic · Google · Perplexity SOTA models analyze every regulatory question in parallel.
FDA-Investigator Simulations
Practice audits with scored debriefs. Find weaknesses before the real inspection ever happens.
Warning Letters Analyzed
1162+ deficiencies mapped to QMSR/ISO 13485 clauses, refreshed daily from FDA.
Everything a QMS leader needs
Seven integrated tools that turn regulatory work from reactive scrambles into a predictable cadence.
Audit Coach
Practice FDA-style and ISO inspections with an AI investigator. Multi-turn questioning, scored debriefs, and targeted weakness reports help you train your team safely between real audits.
Gap Analysis
Upload procedures across 28 QMS document types and get a 0–100% readiness score against QMSR. AI identifies missing clauses, suggests remediation, and exports a board-ready PDF.
Council Mode NEW
Eleven SOTA models stream answers in parallel — OpenAI, Anthropic, Google, Perplexity. Compare specialist perspectives, see consensus metrics, and ground decisions in cited sources.
Warning Letter Insights
Every FDA medical-device warning letter, automatically fetched daily, with deficiencies mapped to 21 CFR / QMSR / ISO 13485 clauses. Spot enforcement trends before they hit you.
CAPA Management
Generate, track, and close corrective actions with a full audit trail and 21 CFR Part 11 dual-control approval workflow. Cross-link CAPAs to FMEA risks and source warning letters.
QMS OS Agent Beta
Supervised autonomous CAPA investigations. The agent drafts root-cause analyses and remediation plans; you review and approve every action via a one-click human gate.
FMEA Worksheet NEW
ISO 14971-aligned with AI-suggested failure modes from a 3-model council. Color-coded RPN matrix, CAPA cross-links, PDF/Excel export, and append-only audit history for traceability.
Simple pricing
Self-serve tiers for small teams. Managed Service overlay available on Premium and Enterprise.
Free
- ~5 AI regulatory scans/mo (a taste)
- Regulatory radar — browse alerts
- Compliance Exposure diagnostic
- Audit Coach (3 sims/mo)
- Warning Letter Browser
- 3 FMEAs / 20 items
Pro Most popular
- Unlimited regulatory scans & custom alerts
- Unlimited audit simulations
- Gap Analysis (28 doc types)
- Council Mode (11 models)
- Unlimited FMEA + CAPA
- QMS OS Agent (Beta)
- PDF / Excel exports
Premium New
- Everything in Pro
- Management Review & Process Validation
- Quality Statistics (sampling, Cp/Cpk, Gage R&R)
- Supplier quality bundle
- AIAG quality tools: PFMEA / DFMEA / 8D / PPAP / APQP
- Multi-standard gap analysis (ISO 9001, AS9100D, IATF 16949)
- Recall Effectiveness planner
- Priority email support
Enterprise
- Everything in Premium
- SSO + audit-trail export
- Custom regulatory frameworks
- Dedicated CSM
- Managed Service overlay