IQVIA SmartSolve CAPA Management
IQVIA SmartSolve CAPA Management is a corrective and preventive action solution for life sciences organizations seeking to manage quality issues and regulato…
What IQVIA SmartSolve CAPA Management is
IQVIA SmartSolve CAPA Management is a corrective and preventive action solution for life sciences organizations seeking to manage quality issues and regulatory risk. Teams can record problems, define and monitor corrective and preventive actions, and assess whether each CAPA was effective. CAPAs may be standalone or linked to Deviation Management, with connections also listed for Complaint, Document, Change, Event, Audit, and Nonconformance Management. Forms or automated integration can capture issues, which users can assess with RPN scoring. AI assistance can draft summaries using precedent information. Reporting, trend analysis, Pareto charts, and Quality Intelligence powered by Microsoft Power BI support risk review. Automated notifications, escalation, and milestone tracking support the workflow. SmartSolve APIs can connect CAPA information with CRM, ERP, LIMS, MES, and PLM systems. Role-based security, audit trails, and electronic signatures are listed controls. IQVIA says SmartSolve is ISO 27001 and ISO 9001 certified and built on Microsoft Azure. It is available through web and API platforms. Pricing is on request; prospective customers can contact IQVIA or request a demo.
Good
- CAPAs can be standalone or linked to Deviation Management.
- RPN scoring supports risk assessment.
- AI can draft summaries using precedent information.
- Workflow includes escalation and milestone tracking.
- Electronic signatures and audit trails are listed.
Watch out
- Pricing is available on request.
- The listed platforms are web and API.
- CAPA effectiveness checks require team review.
Who it suits
This product suits medical device, pharmaceutical, and diagnostic companies managing corrective and preventive actions. It is intended for teams that need CAPA workflows connected to quality or business systems.
Verdict
SmartSolve CAPA Management combines action tracking, risk review, and connections to quality and business systems. Organizations considering it should request a demo and confirm how its integrations fit their workflows.
Plans and prices
From IQVIA SmartSolve CAPA Management's own pricing page, checked 2 Oct 2026.
| Plan | Price | What it gives you |
|---|---|---|
| IQVIA SmartSolve CAPA Management | Priced on request | Pricing not stated on the pages reviewed; IQVIA offers a contact or demo inquiry. |
The facts
Each one read from IQVIA SmartSolve CAPA Management's own pages, with the date it was checked.
What it does
- AI assistance
- The fact sheet says AI can draft summaries, use precedent information, and improve consistency.checked 2 Oct 2026
- Analytics
- Reporting, trend analysis, and Pareto charts help identify risks; Quality Intelligence powered by Microsoft Power BI provides actionable insights.checked 2 Oct 2026
- Business integrations
- CAPA data can be integrated with CRM, ERP, LIMS, MES, and PLM systems through SmartSolve APIs.checked 2 Oct 2026
- CAPA workflow
- Teams can record problems, establish and monitor corrective and preventive actions, and review each CAPA’s effectiveness.checked 2 Oct 2026
- Commercial inquiry
- IQVIA’s SmartSolve eQMS page invites prospective customers to talk to a Quality Expert or request a personalized demo.checked 2 Oct 2026
- Hosting
- IQVIA says SmartSolve is built on Microsoft Azure.checked 2 Oct 2026
- Intended users
- The product page identifies medical device, pharmaceutical, and diagnostic companies as its target organizations.checked 2 Oct 2026
- Purpose
- An AI-enabled, risk-based solution for life sciences organizations to manage corrective and preventive actions, reduce regulatory risk, and support compliance.checked 2 Oct 2026
- Quality integrations
- The fact sheet lists connections to Complaint, Document, Change, Event, Audit, Nonconformance, and Deviation Management.checked 2 Oct 2026
- Risk assessment
- Users can capture issues through forms or automated integration and assess risk using RPN (Risk Priority Number).checked 2 Oct 2026
- Security and compliance
- The fact sheet lists role-based security, audit trails, and electronic signatures, and says SmartSolve is ISO 27001 and ISO 9001 certified.checked 2 Oct 2026
- Standalone or linked records
- CAPAs can be integrated with Deviation Management or created as standalone CAPAs.checked 2 Oct 2026
- Workflow controls
- Automated notifications, escalation, and milestone tracking support timely CAPA closure.checked 2 Oct 2026
Alternatives to IQVIA SmartSolve CAPA Management
- 1
Adaptive FRACAS
Free planAndroidiOSWebAPI7.3From $199.45 a month - 2
ComplianceQuest
AndroidiOSWebAPI7.3From $30 a month - 3
Intelex Inspection Management
AndroidiOSWebAPI7.0From $44 a year - 4
ForgeSOP CAPA
AndroidiOSWeb6.8From $7 a month - 5
CAPA Engine
Free planWeb6.7From $149 a month - 6
Donesafe
AndroidiOSWebAPI6.5