IQVIA SmartSolve CAPA Management
Ranked in Corrective and Preventive Action Software ·No free plan on record
About
IQVIA SmartSolve CAPA Management is an AI-enabled system for life sciences teams managing corrective and preventive actions. Teams can log problems, define and track actions, and assess whether a CAPA was effective. A CAPA may stand alone or link to Deviation Management; other listed quality connections include Complaint, Document, Change, Event, Audit, and Nonconformance Management. SmartSolve APIs can connect CAPA data with CRM, ERP, LIMS, MES, and PLM systems. AI assistance can draft summaries based on precedent information. Teams can capture issues through forms or automated integration, assess risk with RPN, and use reports, trend analysis, and Pareto charts to spot risks. Quality Intelligence uses Microsoft Power BI. Notifications, escalation, and milestone tracking support workflow management. Security features include role-based access, 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.
Who it is for
It suits medical device, pharmaceutical, and diagnostic organizations that need to manage CAPA workflows and connect quality records with other systems. Teams seeking CAPA risk assessment, effectiveness reviews, or related analytics may also find the listed capabilities relevant.
What is good
- CAPAs can be standalone or linked to Deviation Management.
- SmartSolve APIs connect CAPA data with business systems.
- AI can draft summaries using precedent information.
- Includes RPN risk assessment and effectiveness checks.
- Lists audit trails and electronic signatures.
What to know first
- Pricing is available on request.
- No mobile platform is listed.
Verdict
SmartSolve brings CAPA tracking, risk assessment, integrations, and effectiveness review into a quality management workflow. Its listed connections and controls are relevant to regulated life sciences teams, but pricing requires an inquiry.
Compared on corrective and preventive action software
Facts
- 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 · 2 Oct 2026
- CAPA workflow
- Teams can record problems, establish and monitor corrective and preventive actions, and review each CAPA’s effectiveness.iqvia.com · 2 Oct 2026
- Standalone or linked records
- CAPAs can be integrated with Deviation Management or created as standalone CAPAs.iqvia.com · 2 Oct 2026
- Quality integrations
- The fact sheet lists connections to Complaint, Document, Change, Event, Audit, Nonconformance, and Deviation Management.iqvia.com · 2 Oct 2026
- Business integrations
- CAPA data can be integrated with CRM, ERP, LIMS, MES, and PLM systems through SmartSolve APIs.iqvia.com · 2 Oct 2026
- AI assistance
- The fact sheet says AI can draft summaries, use precedent information, and improve consistency.iqvia.com · 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 · 2 Oct 2026
- Risk assessment
- Users can capture issues through forms or automated integration and assess risk using RPN (Risk Priority Number).iqvia.com · 2 Oct 2026
- Workflow controls
- Automated notifications, escalation, and milestone tracking support timely CAPA closure.iqvia.com · 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 · 2 Oct 2026
- Hosting
- IQVIA says SmartSolve is built on Microsoft Azure.iqvia.com · 2 Oct 2026
- Intended users
- The product page identifies medical device, pharmaceutical, and diagnostic companies as its target organizations.iqvia.com · 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 · 2 Oct 2026
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Where it ranks on Inferse
Sources
- iqvia.com/library/fact-sheets/smartsolve-capa-man· checked 2 Oct 2026
- iqvia.com/-/media/iqvia/pdfs/library/fact-sheets/· checked 2 Oct 2026
- iqvia.com/solutions/safety-regulatory-compliance/· checked 2 Oct 2026