AssurX CAPA Software vs Qualityze CAPA Management
AssurX CAPA Software
assurx.com
Qualityze CAPA Management
qualityze.comSide by side
| Figure | AssurX CAPA Software | Qualityze CAPA Management |
|---|---|---|
| Price from | — | — |
| Free plan | — | — |
| Free trial | — | — |
| Open source | — | — |
| Web | Yes | Yes |
| API | Yes | Yes |
| Self-hosted | Yes | — |
| Plans published | 1 | 1 |
| Spec score · Corrective and Preventive Action Software | 7.6 (#11) | 6.8 (#19) |
| 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 pricing page says subscriptions include native ERP, LIMS, and third-party integrations. |
| Intended users | AssurX describes its platform as built for organizations in highly regulated environments and names industries including medical devices, pharma, biotech, food, electronics, aerospace, energy, and manufacturing. | The product page identifies quality leaders, manufacturing operations, QA/QC and inspection teams, CAPA coordinators and investigators, compliance teams, and supplier quality managers. |
| Purpose | The CAPA solution manages corrective and preventive actions from incident capture through investigation, action, effectiveness checks, and closure. | Manages corrective and preventive actions from initiation through closure, including investigation, action assignment, and effectiveness checks. |
| Root cause analysis | It supports structured root cause analysis, including 5 Whys and fishbone methods. | The product supports structured investigations with root cause tools such as the 5Why method. |
| 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 page describes SSO, MFA, and role-based access on its Salesforce-native architecture. |
| Support | Technical support is available to designated company contacts by phone, fax, or email, with same-day responses during regional business hours. | Every subscription includes dedicated support, software updates, validation packages, user guides, and onboarding. |
Plans
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.
Qualityze CAPA Management
Qualityze CAPA Management has no write-up on Specifiction yet; its figures are above.