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SPECIFICTION
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CAPA Engine vs Greenlight Guru

CAPA Engine

capaengine.com

Greenlight Guru

greenlight.guru

Side by side

FigureCAPA EngineGreenlight Guru
Price from$149/mo$750/mo
Free planYes—
Free trial——
Open source——
WebYesYes
API—Yes
Plans published54
Spec score · Corrective and Preventive Action Software8.1 (#4)7.4 (#13)
IntegrationsThe site says users can export to Word or PDF and import into Greenlight Guru, MasterControl, Qualio, ETQ, or another eQMS.Pre-built integrations include Jira, GitHub, Google Drive, and Microsoft Office for the web; the REST API supports custom connections.
PurposeCAPA Engine structures nonconformance reviews into root cause analysis, corrective actions, effectiveness checks, and investigation intelligence formatted to a regulatory framework.Greenlight Guru provides quality management, product development, and clinical evidence software designed for medical device companies.
SecurityThe 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.Greenlight Guru says it is certified to ISO 27001, ISO 42001, ISO 9001, and SOC 2, and that subscriptions include role-based security and encryption.
SupportSupport 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.Subscriptions include a dedicated customer success manager, training resources, and support; implementation is quoted separately.

Plans

CAPA Engine

  • FreeFree
  • Pay Per CAPA$39, paid once
  • Starter$149 a month
  • Team$349 a month
  • EnterprisePriced on request

CAPA Engine pricing →

Greenlight Guru

  • Greenlight Guru Clinical Essentials$9,000 a year
  • Greenlight Guru eQMS$12,000 a year
  • Greenlight Guru Clinical PlusPriced on request
  • Greenlight Guru Clinical ProfessionalPriced on request

Greenlight Guru pricing →

In their own words

CAPA Engine

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.

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Greenlight Guru

Greenlight Guru has no write-up on Specifiction yet; its figures are above.

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