CAPA Engine vs Donesafe
CAPA Engine
capaengine.comDonesafe
donesafe.comSide by side
| Figure | CAPA Engine | Donesafe |
|---|---|---|
| Price from | $149/mo | — |
| Free plan | Yes | — |
| Free trial | — | Yes |
| Open source | — | — |
| Web | Yes | Yes |
| Windows | — | Yes |
| iOS | — | Yes |
| Android | — | Yes |
| API | — | Yes |
| Plans published | 5 | 1 |
| Spec score · Corrective and Preventive Action Software | 8.1 (#4) | 7.8 (#9) |
| Integrations | The site says users can export to Word or PDF and import into Greenlight Guru, MasterControl, Qualio, ETQ, or another eQMS. | Donesafe offers integrations with major ERP, HR, and payroll systems, direct links to regulators and insurance providers, and a RESTful API. |
| 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. | The company says Donesafe meets ISO 27001 standards and uses encryption, data sovereignty controls, physical firewalls, and server hardening. |
| 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. | Support options include implementation, data reporting, training, integrations, project management, and account management. |
Plans
CAPA Engine
- FreeFree
- Pay Per CAPA$39, paid once
- Starter$149 a month
- Team$349 a month
- EnterprisePriced on request
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.