AssurX CAPA Software vs CAPA Engine
AssurX CAPA Software
assurx.com
CAPA Engine
capaengine.comSide by side
| Figure | AssurX CAPA Software | CAPA Engine |
|---|---|---|
| Price from | — | $149/mo |
| Free plan | — | Yes |
| Free trial | — | — |
| Open source | — | — |
| Web | Yes | Yes |
| API | Yes | — |
| Self-hosted | Yes | — |
| Plans published | 1 | 5 |
| Spec score · Corrective and Preventive Action Software | 7.6 (#11) | 8.1 (#4) |
| Integrations | AssurX says it integrates with ERP, PLM, MES, LIMS, CRM, and CMMS systems, and names SAP, Salesforce, Oracle, PTC/Windchill, and ServiceNow among examples. | The site says users can export to Word or PDF and import into Greenlight Guru, MasterControl, Qualio, ETQ, or another eQMS. |
| Purpose | The CAPA solution manages corrective and preventive actions from incident capture through investigation, action, effectiveness checks, and closure. | CAPA Engine structures nonconformance reviews into root cause analysis, corrective actions, effectiveness checks, and investigation intelligence formatted to a regulatory framework. |
| Root cause analysis | It supports structured root cause analysis, including 5 Whys and fishbone methods. | Root cause analysis uses Ishikawa and 5-Why methods, ranked probable causes, evidence evaluation, and an investigation plan. |
| Security | AssurX states that it is ISO/IEC 27001:2022 certified and SOC 2 compliant, and uses 256-bit encryption for data in transit and at rest. | 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. |
| Support | Technical support is available to designated company contacts by phone, fax, or email, with same-day responses during regional business hours. | 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. |
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
AssurX CAPA Software
AssurX CAPA Software manages corrective and preventive actions from incident capture through investigation, assigned work, effectiveness checks, and closure. CAPAs can begin with audits, deviations, complaints, nonconformances, incidents, or risk assessments. Structured root-cause methods include 5 Whys, fishbone diagrams, 8D, and FMEA. Configurable workflows handle ownership, due dates, reminders, escalation, and approvals. Records can connect CAPAs with related issues, risks, changes, and supporting documents while preserving controlled records and audit trails. The software includes electronic signatures and a secure, time-stamped archive of record changes. AssurX lists support for FDA requirements and alignment with ISO and GxP requirements, including 21 CFR Part 820 and Part 11, EU MDR, ISO 9001, ISO 13485, and EU IVDR. Cloud and on-premises licensing use the same software, with an open API and integrations for ERP, PLM, MES, LIMS, CRM, and CMMS systems. Pricing is available on request.
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.