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IQVIA SmartSolve CAPA Management
What it is
IQVIA SmartSolve CAPA Management is a paid, AI-enabled solution for corrective and preventive actions in life sciences organizations. Medical device, pharmaceutical, and diagnostic companies can record problems, define actions, monitor progress, and review CAPA effectiveness. Records may stand alone or connect with Deviation Management, 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. Teams can capture issues through forms or automated integrations, assess risk with Risk Priority Number scoring, and use reporting, trend analysis, Pareto charts, and Microsoft Power BI-based Quality Intelligence. Notifications, escalation, and milestone tracking support closure. Security features include role-based controls, audit trails, and electronic signatures. IQVIA says SmartSolve is ISO 27001 and ISO 9001 certified, built on Microsoft Azure, and available through web and API platforms. Pricing is on request.
For and against
For
- Supports standalone and linked CAPA records
- Connects with CRM, ERP, LIMS, MES, and PLM systems
- Provides RPN risk assessment
- Includes electronic signatures and audit trails
- Offers effectiveness checks
Against
- Paid product with pricing on request
- Designed for life sciences organizations
- Requires a commercial inquiry or demo
The verdict
SmartSolve CAPA Management covers CAPA intake, risk review, action tracking, analytics, and compliance controls in one platform. Its life sciences focus and requested pricing make an inquiry necessary before selection.
Who it suits
It is intended for medical device, pharmaceutical, and diagnostic companies managing regulated quality processes. Quality teams needing CAPA workflows, integrations, risk assessment, and effectiveness checks may fit its target audience.
Plans and prices
IQVIA SmartSolve CAPA Management
Pricing not stated on the pages reviewed; IQVIA offers a contact or demo inquiry.
Read 2 Oct 2026 · iqvia.com
On the record
- AI assistance
- The fact sheet says AI can draft summaries, use precedent information, and improve consistency.iqvia.com · read 2 Oct 2026
- Analytics
- Reporting, trend analysis, and Pareto charts help identify risks; Quality Intelligence powered by Microsoft Power BI provides actionable insights.iqvia.com · read 2 Oct 2026
- Business integrations
- CAPA data can be integrated with CRM, ERP, LIMS, MES, and PLM systems through SmartSolve APIs.iqvia.com · read 2 Oct 2026
- CAPA workflow
- Teams can record problems, establish and monitor corrective and preventive actions, and review each CAPA’s effectiveness.iqvia.com · read 2 Oct 2026
- Commercial inquiry
- IQVIA’s SmartSolve eQMS page invites prospective customers to talk to a Quality Expert or request a personalized demo.iqvia.com · read 2 Oct 2026
- Hosting
- IQVIA says SmartSolve is built on Microsoft Azure.iqvia.com · read 2 Oct 2026
- Intended users
- The product page identifies medical device, pharmaceutical, and diagnostic companies as its target organizations.iqvia.com · read 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.iqvia.com · read 2 Oct 2026
- Quality integrations
- The fact sheet lists connections to Complaint, Document, Change, Event, Audit, Nonconformance, and Deviation Management.iqvia.com · read 2 Oct 2026
- Risk assessment
- Users can capture issues through forms or automated integration and assess risk using RPN (Risk Priority Number).iqvia.com · read 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.iqvia.com · read 2 Oct 2026
- Standalone or linked records
- CAPAs can be integrated with Deviation Management or created as standalone CAPAs.iqvia.com · read 2 Oct 2026
- Workflow controls
- Automated notifications, escalation, and milestone tracking support timely CAPA closure.iqvia.com · read 2 Oct 2026
