There's too much at stake. Do a sanity check. Challenge your CAPA.
Select your industry. Paste a nonconformance. Get root cause analysis, corrective actions, effectiveness checks, and investigation intelligence — formatted to your regulatory framework.
Select your industry. Describe the event. CAPA Engine challenges your investigation - exposing weak root causes, missing evidence, and audit risks before it’s too late.
Built for regulated environments.Your data stays private. Your work stays yours.
Regulatory frameworks built in
Deliverables produced by CAPA Engine
Root Cause Analysis
Ishikawa + 5-Why with ranked probable causes, evidence evaluation, and investigation plan.
4-Layer Corrective Action
Containment, correction, systemic, preventive — with regulatory clause references.
Effectiveness Checks
Quantitative acceptance criteria, monitoring periods, and pass/fail logic.
Reasoning Graph
Evidence for and against each cause with confidence scores and defensible reasoning chains.
Intelligence Panel
Failure pattern detection, auto-FMEA draft, and recurrence prediction scoring.
Multi-Format Export
CAPA, 8D, SCAR, and Deviation reports in Word and PDF.
Real examples
See real CAPA examples across industries
Explore structured example investigations for software, supplier quality, manufacturing, and pharma batch failures.
Medical Device Software (SaMD)
Algorithm performance, patient-risk classification, and software CAPA structure.
Read example ->Supplier Quality Issue
Incoming inspection escape, supplier process drift, and receiving controls.
Read example ->Manufacturing Deviation
Machining drift, setup verification, reaction plans, and process control.
Read example ->Pharma Batch Failure
Dissolution failure, process variability, and batch-level CAPA strategy.
Read example ->Complete output walkthrough
See the full CAPA — start to finish
This is a real investigation output from CAPA Engine. Classification, Ishikawa analysis, root causes, corrective actions, effectiveness checks, reasoning graph, and recurrence prediction — all generated from a single nonconformance description.
CAPA Engine™ Full Investigation Demo
Scroll through a real end-to-end investigation example showing the complete value of the platform.
Not another generic AI tool
A founder-led quality platform — built with real accountability
CAPA Engine was built by a quality systems professional with direct experience in CAPA, compliance, and regulated product environments — not a general-purpose AI team.
The platform reflects input from quality leaders across medical devices, aerospace, pharma, and regulated manufacturing, and is shaped by how investigations and quality records are actually reviewed — not just how they are written.
Ongoing external feedback keeps the platform practical, disciplined, and grounded in real user needs.
MBA + Ohio State Bioethics Program
AACSB-accredited MBA, Ohio State bioethics program
INCOSE ASEP Certified
Systems engineering professional
Advisory Input from Quality Leaders
Medical devices, aerospace, hospital systems, regulated manufacturing
Cross-Industry QMS Expertise
ISO 13485, 21 CFR 820, AS9100D, IATF 16949
Founder-Led and Accountability-Driven
Built with external feedback to stay practical, credible, and focused
Simple pricing
First root cause analysis is free. Pay per CAPA or subscribe when you are ready.
Pay Per CAPA
$39 / CAPA
One-time. No commitment.
- ✓ Any industry
- ✓ Full investigation
- ✓ All export formats
- ✓ Reasoning graph
- ✓ Intelligence panel
Starter
$149 / month
For individual quality engineers.
- ✓ Everything in Pay Per CAPA
- ✓ 10 CAPAs per month
- ✓ CAPA history dashboard
- ✓ Priority generation
Team
$349 / month
For quality teams.
- ✓ Everything in Starter
- ✓ 30 CAPAs per month
- ✓ Shared account access (up to 5 users)
- ✓ Priority generation
Questions quality engineers ask
Stop staring at blank CAPA forms
Paste your first nonconformance. See a structured investigation in minutes.