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 is for
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 is good
- 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.
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.
Get started with IQVIA SmartSolve CAPA Management
- Visit the IQVIA SmartSolve CAPA Management page.
- Contact a Quality Expert or request a personalized demo.
- Use the web or API platform.
Questions about IQVIA SmartSolve CAPA Management
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.
IQVIA SmartSolve CAPA Management plans and pricing
All plansCompared on corrective and preventive action software
- Root-cause methods
- 5 whys, fishbone, scatter plot diagrams, histograms, Pareto charts, brainstorming
- Effectiveness checks
- Yes
- Electronic signatures
- Yes
- Audit trail
- Yes
- Mobile access
- Yes
