AssurX CAPA Software vs Donesafe
AssurX CAPA Software
assurx.comDonesafe
donesafe.comSide by side
| Figure | AssurX CAPA Software | Donesafe |
|---|---|---|
| Price from | — | — |
| Free plan | — | — |
| Free trial | — | Yes |
| Open source | — | — |
| Web | Yes | Yes |
| Windows | — | Yes |
| iOS | — | Yes |
| Android | — | Yes |
| API | Yes | Yes |
| Self-hosted | Yes | — |
| Plans published | 1 | 1 |
| Spec score · Corrective and Preventive Action Software | 7.6 (#11) | 7.8 (#9) |
| 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. | Donesafe offers integrations with major ERP, HR, and payroll systems, direct links to regulators and insurance providers, and a RESTful API. |
| 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 company describes Donesafe as serving organizations across industries, including construction, manufacturing, healthcare, and government. |
| 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 company says Donesafe meets ISO 27001 standards and uses encryption, data sovereignty controls, physical firewalls, and server hardening. |
| Support | Technical support is available to designated company contacts by phone, fax, or email, with same-day responses during regional business hours. | Support options include implementation, data reporting, training, integrations, project management, and account management. |
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.