AssurX CAPA Software vs MasterControl CAPA
AssurX CAPA Software
assurx.comMasterControl CAPA
mastercontrol.comSide by side
| Figure | AssurX CAPA Software | MasterControl CAPA |
|---|---|---|
| Price from | — | — |
| Free plan | — | — |
| Free trial | — | — |
| Open source | — | — |
| Web | Yes | Yes |
| API | Yes | — |
| Self-hosted | Yes | — |
| Plans published | 1 | 1 |
| Spec score · Corrective and Preventive Action Software | 7.6 (#11) | 6.7 (#21) |
| 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. | MasterControl describes its platform as connecting quality, manufacturing and asset management, with integrations to other critical business systems. |
| 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. | MasterControl presents CAPA as a solution for life sciences and other organisations operating in regulated environments. |
| Purpose | The CAPA solution manages corrective and preventive actions from incident capture through investigation, action, effectiveness checks, and closure. | CAPA software helps life sciences organisations identify root causes of quality issues and prevent them from recurring. |
| Support | Technical support is available to designated company contacts by phone, fax, or email, with same-day responses during regional business hours. | The UK product page provides a Customer Support link and lists UK sales contact details. |
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.
MasterControl CAPA
MasterControl CAPA has no write-up on Specifiction yet; its figures are above.