AssurX CAPA Software vs IQVIA SmartSolve CAPA Management
AssurX CAPA Software
assurx.comIQVIA SmartSolve CAPA Management
iqvia.comSide by side
| Figure | AssurX CAPA Software | IQVIA SmartSolve 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) | 6.9 (#16) |
| Hosting | AssurX offers cloud and on-premises licensing options and says the software is identical across both implementations. | IQVIA says SmartSolve is built on Microsoft Azure. |
| 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 medical device, pharmaceutical, and diagnostic companies as its target organizations. |
| Purpose | The CAPA solution manages corrective and preventive actions from incident capture through investigation, action, effectiveness checks, and closure. | An AI-enabled, risk-based solution for life sciences organizations to manage corrective and preventive actions, reduce regulatory risk, and support compliance. |
| Workflow controls | Users can assign and track actions with ownership, due dates, escalation, approval controls, reminders, and configurable workflows. | Automated notifications, escalation, and milestone tracking support timely CAPA closure. |
Plans
IQVIA SmartSolve CAPA Management
- IQVIA SmartSolve CAPA ManagementPriced 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.
IQVIA SmartSolve CAPA Management
IQVIA SmartSolve CAPA Management is a paid, risk-based system for corrective and preventive action in life sciences organizations. Teams can record problems, define and monitor corrective and preventive actions, and review each CAPA’s effectiveness. CAPAs may stand alone or connect with Deviation Management, while listed quality connections include Complaint, Document, Change, Event, Audit, and Nonconformance Management. SmartSolve APIs connect CAPA data with CRM, ERP, LIMS, MES, and PLM systems. AI assistance can draft summaries using precedent information. Issues can enter through forms or automated integration and be assessed with RPN scoring. Reporting, trend analysis, Pareto charts, and Microsoft Power BI-based Quality Intelligence support risk review. Automated notifications, escalation, and milestone tracking support closure. Listed controls include role-based security, audit trails, and electronic signatures. IQVIA says SmartSolve is ISO 27001 and ISO 9001 certified and built on Microsoft Azure. It is available through web and API platforms, with pricing on request.