IQVIA SmartSolve CAPA Management

C
C tier on Corrective and Preventive Action SoftwareScore 6.2 · #16 of 23
Android app
Not listed
Free plan
No
Runs on
api, Web
iqvia.com
The IQVIA SmartSolve CAPA Management homepage

Summary

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.

Who it is for

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.

What is 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.

What to know first

  • Pricing is available on request.
  • The listed platforms are web and API.
  • CAPA effectiveness checks require team review.

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.

IQVIA SmartSolve CAPA Management plans and pricing

All plans
IQVIA SmartSolve CAPA Management Not published Pricing not stated on the pages reviewed; IQVIA offers a contact or demo inquiry. iqvia.com · 2 Oct 2026

Compared on corrective and preventive action software

Root-cause methods
5 whys, fishbone, scatter plot diagrams, histograms, Pareto charts, brainstormingiqvia.com
Effectiveness checks
Yesiqvia.com
Electronic signatures
Yesiqvia.com
Audit trail
Yesiqvia.com
Mobile access
Yesiqvia.com

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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