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IQVIA SmartSolve CAPA Management

iqvia.com

WebAPI
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Spec score 6.9 #16 of 23 in Corrective and Preventive Action Software

What it is

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.

Spec sheet

Purpose
An AI-enabled, risk-based solution for life sciences organizations to manage corrective and preventive actions, reduce regulatory risk, and support compliance.Read 2 Oct 2026 · iqvia.com
Intended users
The product page identifies medical device, pharmaceutical, and diagnostic companies as its target organizations.Read 2 Oct 2026 · iqvia.com
AI assistance
The fact sheet says AI can draft summaries, use precedent information, and improve consistency.Read 2 Oct 2026 · iqvia.com
Analytics
Reporting, trend analysis, and Pareto charts help identify risks; Quality Intelligence powered by Microsoft Power BI provides actionable insights.Read 2 Oct 2026 · iqvia.com
Business integrations
CAPA data can be integrated with CRM, ERP, LIMS, MES, and PLM systems through SmartSolve APIs.Read 2 Oct 2026 · iqvia.com
CAPA workflow
Teams can record problems, establish and monitor corrective and preventive actions, and review each CAPA’s effectiveness.Read 2 Oct 2026 · iqvia.com
Commercial inquiry
IQVIA’s SmartSolve eQMS page invites prospective customers to talk to a Quality Expert or request a personalized demo.Read 2 Oct 2026 · iqvia.com
Hosting
IQVIA says SmartSolve is built on Microsoft Azure.Read 2 Oct 2026 · iqvia.com
Quality integrations
The fact sheet lists connections to Complaint, Document, Change, Event, Audit, Nonconformance, and Deviation Management.Read 2 Oct 2026 · iqvia.com
Risk assessment
Users can capture issues through forms or automated integration and assess risk using RPN (Risk Priority Number).Read 2 Oct 2026 · iqvia.com
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.Read 2 Oct 2026 · iqvia.com
Standalone or linked records
CAPAs can be integrated with Deviation Management or created as standalone CAPAs.Read 2 Oct 2026 · iqvia.com
Workflow controls
Automated notifications, escalation, and milestone tracking support timely CAPA closure.Read 2 Oct 2026 · iqvia.com

Plans and prices

IQVIA SmartSolve CAPA Management Priced on request Pricing not stated on the pages reviewed; IQVIA offers a contact or demo inquiry. Read 2 Oct 2026 · iqvia.com

Every IQVIA SmartSolve CAPA Management plan and price →

Strong points and limits

Strong points

  • CAPAs can stand alone or link with Deviation Management
  • Integrates with quality, business, and laboratory systems
  • AI can draft summaries using precedent information
  • RPN risk assessment and Pareto analysis
  • Electronic signatures and audit trails

Limits

  • Pricing is available only on request
  • Designed for life sciences organizations
  • Implementation depends on listed integrations and workflows

Who it suits

It is aimed at medical device, pharmaceutical, and diagnostic companies managing regulated CAPA processes.

Verdict

SmartSolve CAPA Management covers CAPA records, risk assessment, analytics, integrations, and controlled workflow steps. Its paid, web-and-API offering is focused on regulated life sciences teams seeking connected quality processes.

Where Specifiction places it

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