AssurX CAPA Software vs pHKapa
AssurX CAPA Software
assurx.compHKapa
phkapa.netSide by side
| Figure | AssurX CAPA Software | pHKapa |
|---|---|---|
| Price from | — | €65/mo |
| Free plan | — | Yes |
| Free trial | — | Yes |
| Open source | — | — |
| Web | Yes | Yes |
| API | Yes | — |
| Self-hosted | Yes | Yes |
| Plans published | 1 | 3 |
| Spec score · Corrective and Preventive Action Software | 7.6 (#11) | 7.6 (#12) |
| Hosting | AssurX offers cloud and on-premises licensing options and says the software is identical across both implementations. | The Cloud service centrally hosts pHKapa and associated data on the maker’s servers; the Community and Full Pack listings require a web server. |
| Purpose | The CAPA solution manages corrective and preventive actions from incident capture through investigation, action, effectiveness checks, and closure. | pHKapa manages corrective and preventive actions by helping teams analyze problems, find root causes, document corrections, and prevent recurrence. |
| 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 Cloud package advertises advanced HTTPS protection and daily backups. |
| Support | Technical support is available to designated company contacts by phone, fax, or email, with same-day responses during regional business hours. | The maker lists 24/7 customer service for Cloud and Full Pack, community support for Community, and free online resources and specialized services for users. |
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.
pHKapa
pHKapa manages corrective and preventive actions for teams investigating complaints, defects, and nonconformities. It moves issues through registration, review, planning, implementation, and verification, and supports corrective, preventive, and other action types with effectiveness checks. Root-cause analysis includes the 5 Whys and another schema. Automated workflows and ticket history record who verifies, modifies, or closes tickets. Internal and email notifications are included; users can attach documents and comment, while the Community package also offers CSV export and ticket reports. pHKapa is available as self-hosted software or as a Cloud service hosted on the maker’s servers. Community and Full Pack require a web server, PHP 7, and MySQL 5 or higher. Community is free; Full Pack costs $48 once. Cloud costs €65 per month and includes 5GB storage, daily backups, advanced HTTPS protection, and a 30-day trial. The maker describes design, manufacturing, quality improvement, and engineering teams as users.