- Home
- Corrective and Preventive Action Software
- CAPA Engine
CAPA Engine
What it is
CAPA Engine is a web tool for organizing nonconformance investigations, corrective actions, and effectiveness reviews within regulatory frameworks. Root-cause work can use Ishikawa and 5-Why methods, rank possible causes, assess evidence, and lay out an investigation plan. Action plans cover containment, correction, systemic measures, and prevention, while effectiveness checks can specify measurable acceptance criteria, monitoring periods, and pass-or-fail logic. A reasoning graph records evidence for and against causes with confidence scores; an intelligence panel presents failure patterns, draft FMEAs, and recurrence prediction scores. The tool exports CAPA, 8D, SCAR, and Deviation reports to Word or PDF. Listed industries include medical devices, pharma and biotech, aerospace and defense, automotive, food and beverage, and general manufacturing. A free option includes one root cause analysis without an account; a one-time CAPA costs $39, paid once. Monthly plans are $149 a month for Starter and $349 a month for Team. Freelong Health, LLC operates the service.
For and against
For
- Includes Ishikawa and 5-Why methods.
- Exports CAPA, 8D, SCAR, and Deviation reports.
- Offers one free root cause analysis.
- Data is encrypted in transit and at rest.
Against
- Free option includes only one root cause analysis.
- Protected health information should generally be avoided.
- Generated output requires qualified-personnel review.
The verdict
CAPA Engine combines investigation structure, action planning, and report exports, with options from a free analysis to paid plans. Treat its generated material as a starting point for review, and avoid entering sensitive personal information absent a separate written agreement.
Who it suits
CAPA Engine is aimed at quality and compliance teams in the listed manufacturing and regulated industries. Generated output should be reviewed by qualified personnel before it informs decisions.
Plans and prices
Free
1 free root cause analysis · no account needed
Read 7 Oct 2026 · capaengine.com
Pay Per CAPA
1 CAPA · any industry framework · Word export
Read 7 Oct 2026 · capaengine.com
Starter
10 CAPAs per month · individual quality engineers
Read 7 Oct 2026 · capaengine.com
Team
30 CAPAs per month · shared account access up to 5 users
Read 7 Oct 2026 · capaengine.com
Enterprise
Custom enterprise editions · multi-site rollout support · tailored onboarding
Read 7 Oct 2026 · capaengine.com
On the record
- Corrective actions
- The corrective action plan covers containment, correction, systemic, and preventive actions with regulatory clause references.capaengine.com · read 7 Oct 2026
- Effectiveness checks
- Effectiveness checks include quantitative acceptance criteria, monitoring periods, and pass/fail logic.capaengine.com · read 7 Oct 2026
- Exports
- It offers CAPA, 8D, SCAR, and Deviation reports in Word and PDF.capaengine.com · read 7 Oct 2026
- Industries
- The site lists medical devices, pharma and biotech, aerospace and defense, automotive, food and beverage, and general manufacturing as target industries.capaengine.com · read 7 Oct 2026
- Integrations
- The site says users can export to Word or PDF and import into Greenlight Guru, MasterControl, Qualio, ETQ, or another eQMS.capaengine.com · read 7 Oct 2026
- 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.capaengine.com · read 7 Oct 2026
- Maker
- CAPA Engine is operated by Freelong Health, LLC.capaengine.com · read 7 Oct 2026
- 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.capaengine.com · read 7 Oct 2026
- Purpose
- CAPA Engine structures nonconformance reviews into root cause analysis, corrective actions, effectiveness checks, and investigation intelligence formatted to a regulatory framework.capaengine.com · read 7 Oct 2026
- Root cause analysis
- Root cause analysis uses Ishikawa and 5-Why methods, ranked probable causes, evidence evaluation, and an investigation plan.capaengine.com · read 7 Oct 2026
- 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.capaengine.com · read 7 Oct 2026
- 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.capaengine.com · read 7 Oct 2026
- 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.capaengine.com · read 7 Oct 2026
- Use and review
- Generated output should be reviewed by qualified personnel before use in regulatory, quality, compliance, or business decisions.capaengine.com · read 7 Oct 2026
