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CAPA Engine

capaengine.com

From $149/mo Free plan Web
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Spec score 8.1 #4 of 23 in Corrective and Preventive Action Software

What it is

CAPA Engine is a web tool for structuring nonconformance reviews into root cause analysis, corrective actions, effectiveness checks, and investigation intelligence tied to a regulatory framework. Root cause analysis uses Ishikawa and 5-Why methods, ranks probable causes, evaluates evidence, and sets out an investigation plan. Corrective action plans cover containment, correction, systemic, and preventive actions with regulatory clause references. Effectiveness checks can specify quantitative acceptance criteria, monitoring periods, and pass/fail logic. The product describes a reasoning graph that records evidence for and against causes with confidence scores, plus an intelligence panel for failure patterns, auto-FMEA drafts, and recurrence prediction scoring. It exports CAPA, 8D, SCAR, and Deviation reports in Word and PDF. Listed industries include medical devices, pharma and biotech, aerospace and defense, automotive, food and beverage, and general manufacturing. Frameworks include ISO 13485, 21 CFR 820, AS9100D, IATF 16949, ISO 14971, IEC 62304, ICH Q10, SQF, BRC, FSSC 22000, ISO 9001, and NADCAP. A free option provides one root cause analysis; a one-time CAPA costs 39.00 USD. Generated output should be reviewed by qualified personnel before use in decisions.

Spec sheet

Purpose
CAPA Engine structures nonconformance reviews into root cause analysis, corrective actions, effectiveness checks, and investigation intelligence formatted to a regulatory framework.Read 7 Oct 2026 · capaengine.com
Integrations
The site says users can export to Word or PDF and import into Greenlight Guru, MasterControl, Qualio, ETQ, or another eQMS.Read 7 Oct 2026 · capaengine.com
Security
The site states data is encrypted in transit and at rest, is not used to train AI models, and is hosted on SOC 2 compliant infrastructure.Read 7 Oct 2026 · capaengine.com
Support
Support is available by email and the team says it typically responds within one business day; step-by-step documentation and a system status page are also offered.Read 7 Oct 2026 · capaengine.com
Maker
CAPA Engine is operated by Freelong Health, LLC.Read 7 Oct 2026 · capaengine.com
Corrective actions
The corrective action plan covers containment, correction, systemic, and preventive actions with regulatory clause references.Read 7 Oct 2026 · capaengine.com
Effectiveness checks
Effectiveness checks include quantitative acceptance criteria, monitoring periods, and pass/fail logic.Read 7 Oct 2026 · capaengine.com
Exports
It offers CAPA, 8D, SCAR, and Deviation reports in Word and PDF.Read 7 Oct 2026 · capaengine.com
Industries
The site lists medical devices, pharma and biotech, aerospace and defense, automotive, food and beverage, and general manufacturing as target industries.Read 7 Oct 2026 · capaengine.com
Investigation intelligence
The product describes a reasoning graph with evidence for and against causes, confidence scores, and an intelligence panel for failure patterns, auto-FMEA drafts, and recurrence prediction scoring.Read 7 Oct 2026 · capaengine.com
Privacy limit
The privacy policy advises avoiding protected health information, patient identifiers, or other unnecessary highly sensitive personal information unless a separate written agreement says otherwise.Read 7 Oct 2026 · capaengine.com
Root cause analysis
Root cause analysis uses Ishikawa and 5-Why methods, ranked probable causes, evidence evaluation, and an investigation plan.Read 7 Oct 2026 · capaengine.com
Standards
Listed frameworks include ISO 13485, 21 CFR 820, AS9100D, IATF 16949, ISO 14971, IEC 62304, ICH Q10, SQF, BRC, FSSC 22000, ISO 9001, and NADCAP.Read 7 Oct 2026 · capaengine.com
Use and review
Generated output should be reviewed by qualified personnel before use in regulatory, quality, compliance, or business decisions.Read 7 Oct 2026 · capaengine.com

Plans and prices

Free Free 1 free root cause analysis · no account needed Read 7 Oct 2026 · capaengine.com
Pay Per CAPA $39, paid once One-time 1 CAPA · any industry framework · Word export Read 7 Oct 2026 · capaengine.com
Starter $149 a month Billed monthly 10 CAPAs per month · individual quality engineers Read 7 Oct 2026 · capaengine.com
Team $349 a month Billed monthly 30 CAPAs per month · shared account access up to 5 users Read 7 Oct 2026 · capaengine.com
Enterprise Priced on request Custom enterprise editions · multi-site rollout support · tailored onboarding Read 7 Oct 2026 · capaengine.com

Every CAPA Engine plan and price →

Strong points and limits

Strong points

  • Uses Ishikawa and 5-Why methods
  • Includes corrective actions and effectiveness checks
  • Exports CAPA, 8D, SCAR, and Deviation reports
  • Free option includes one root cause analysis
  • Data is encrypted in transit and at rest

Limits

  • Avoid entering unnecessary sensitive personal information
  • Generated outputs require qualified review
  • One-time CAPA costs 39.00 USD

Who it suits

CAPA Engine suits quality and compliance teams conducting nonconformance investigations in its listed industries and frameworks. Its outputs are intended for review by qualified personnel before use in decisions.

Verdict

CAPA Engine brings investigation steps, regulatory references, and report exports into one workflow. Its terms and guidance call for qualified review of generated output and caution against entering unnecessary highly sensitive information.

Where Specifiction places it

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