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IQVIA SmartSolve CAPA Management
What IQVIA SmartSolve CAPA Management is
IQVIA SmartSolve CAPA Management helps life sciences organizations record problems, manage corrective and preventive actions, and assess whether those actions worked. Teams can create CAPAs on their own or connect them with Deviation Management. Risk assessment can use forms or automated issue intake and RPN scoring, while reports, trend analysis, and Pareto charts help surface risks. Quality Intelligence, powered by Microsoft Power BI, provides further insights. AI assistance can draft summaries using precedent information to support consistency. Workflow controls include notifications, escalation, and milestone tracking. The fact sheet lists connections with Complaint, Document, Change, Event, Audit, Nonconformance, and Deviation Management, along with SmartSolve API links to CRM, ERP, LIMS, MES, and PLM systems. Security features include role-based controls, audit trails, and electronic signatures. IQVIA says SmartSolve is ISO 27001 and ISO 9001 certified and built on Microsoft Azure. It is available via web and API; pricing is on request.
Who it suits
It is intended for medical device, pharmaceutical, and diagnostic companies managing CAPA processes. It may suit teams seeking CAPA links to quality and business systems, plus risk review and workflow controls.
What it does well
- CAPAs can stand alone or link to Deviation Management.
- RPN scoring supports risk assessment.
- AI can draft summaries using precedent information.
- Includes audit trails and electronic signatures.
- Offers reporting, trend analysis, and Pareto charts.
What to know first
- Pricing is available on request.
- No mobile access is listed.
Plans
| Plan | Billed and limits | Price |
|---|---|---|
| IQVIA SmartSolve CAPA Management | Pricing not stated on the pages reviewed; IQVIA offers a contact or demo inquiry. | On request |
As iqvia.com lists them, read 2 Oct 2026. The maker's own page has the final word.
Getting started
- Visit the IQVIA SmartSolve CAPA Management page.
- Contact a Quality Expert or request a personalized demo.
- Use the web or API platform.
Verdict
IQVIA SmartSolve CAPA Management combines CAPA workflows with risk assessment, analytics, and quality-system connections. Organizations interested in it need to request pricing or a personalized demo.
Questions
How is IQVIA SmartSolve CAPA Management priced?
Pricing is on request. IQVIA offers a contact or demo inquiry.
Which organizations is it intended for?
Medical device, pharmaceutical, and diagnostic companies.
Which platforms are supported?
The listed platforms are web and API.
Can CAPAs be connected to other systems?
Yes. Listed quality connections include Complaint, Document, Change, Event, Audit, Nonconformance, and Deviation Management. SmartSolve APIs can connect CAPA data with CRM, ERP, LIMS, MES, and PLM systems.
Does it support electronic signatures and audit trails?
Yes. The fact sheet lists both, along with role-based security.
What are its root-cause methods?
Listed methods include 5 whys, fishbone, scatter plot diagrams, histograms, Pareto charts, and brainstorming.
Facts from IQVIA SmartSolve CAPA Management's own pages
- 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
- Business integrations
- CAPA data can be integrated with CRM, ERP, LIMS, MES, and PLM systems through SmartSolve APIs. · 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
- 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
- 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
- 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
- Quality integrations
- The fact sheet lists connections to Complaint, Document, Change, Event, Audit, Nonconformance, and Deviation Management. · 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
- 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
- Standalone or linked records
- CAPAs can be integrated with Deviation Management or created as standalone CAPAs. · iqvia.com, 2 Oct 2026
- Workflow controls
- Automated notifications, escalation, and milestone tracking support timely CAPA closure. · iqvia.com, 2 Oct 2026