IQVIA SmartSolve Complaint Management
- 1Runs onAndroid, iOS, Web
- 2Intake channelsweb
- 3Workflow automationYes
- 4Escalation rulesYes
- 5Investigation toolsYes
- 6Reporting depthadvanced
Overview
IQVIA SmartSolve Complaint Management is an AI-powered platform for life sciences organizations managing complaints, regulatory reporting, and post-market surveillance. Complaint data can arrive through web forms, a secure Quality intake portal, ERP or CRM integrations, web portals, and IQVIA Vigilance Detect. Configurable decision trees help distinguish complaints and adverse events from other inquiries and guide investigation and reporting. Preconfigured workflows support reportability for the FDA, EU, Health Canada, Japan, Australia, the UK, and Switzerland; the system also supports electronic reporting requirements and integration to CDRH, MedDRA, and IMDRF codes. Its AI features include language-processing extraction, generative AI assistance, automated triage, decision support, translation, and predictive analytics. Built-in reporting and trends cover recurring complaints, resolution times, and historical data, while Quality Intelligence uses Microsoft Power BI. SmartSolve connects with nonconformance, CAPA, change management, and document management modules. The fact sheet lists role-based security, password authentication, audit trails, ISO 27001 and ISO 9001 certification, and an Azure-based platform. Pricing is not published; IQVIA invites prospective customers to contact sales.
Who it is for
It is aimed at life sciences organizations handling complaint workflows and regulatory reporting. The Quality intake portal is intended for field personnel and extended demand chain partners, including healthcare professionals, clinical investigators, and customers.
What is good
- Intake supports web forms and ERP or CRM integrations
- Decision trees guide complaint evaluation and reporting
- Reporting workflows cover multiple named jurisdictions
- Connects with SmartSolve quality modules
- Built-in reports cover recurring complaints and resolution times
What to know first
- Pricing is not published
- Opened product pages did not state trial terms
Verdict
SmartSolve brings complaint intake, evaluation, reporting, and analytics into a platform with named regulatory workflows and quality-module connections. Organizations will need to contact IQVIA for pricing and trial information.
IQVIA SmartSolve Complaint Management plans and pricing
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Facts
- Purpose
- The AI-powered solution is for life sciences organizations managing global complaints, regulatory reporting, and post-market surveillance.iqvia.com · 4 Oct 2026
- AI features
- The fact sheet describes NLP extraction, generative AI assistance, automated triage, decision support, translation, and predictive analytics.iqvia.com · 4 Oct 2026
- Intake
- Complaint data can enter through web forms, a secure Quality intake portal, ERP or CRM integrations, web portals, and IQVIA Vigilance Detect.iqvia.com · 4 Oct 2026
- Complaint evaluation
- Configurable decision trees help users distinguish complaints and adverse events from other inquiries and guide consistent investigation and reporting.iqvia.com · 4 Oct 2026
- Regulatory reporting
- Preconfigured decision trees support reportability workflows for FDA, EU, Health Canada, Japan, Australia, UK, and Switzerland.iqvia.com · 4 Oct 2026
- Reporting integrations
- The fact sheet says the system supports electronic reporting requirements and integration to CDRH, MedDRA, and IMDRF codes.iqvia.com · 4 Oct 2026
- Quality modules
- Complaint Management connects with SmartSolve Nonconformance, CAPA, Change Management, and Document Management modules.iqvia.com · 4 Oct 2026
- Security and compliance
- The product fact sheet lists role-based security, password authentication, and audit trails for FDA 21 CFR Part 11 and EU Annex 11 compliance, and says SmartSolve is ISO 27001 and ISO 9001 certified.iqvia.com · 4 Oct 2026
- Hosting
- The fact sheet describes SmartSolve as an AI-enabled, Microsoft Azure-based platform.iqvia.com · 4 Oct 2026
- Analytics
- Built-in reporting and trending cover recurring complaints, resolution times, and historical data; Quality Intelligence is powered by Microsoft Power BI.iqvia.com · 4 Oct 2026
- Intended users
- The Quality intake portal is intended for field personnel and extended demand chain partners including healthcare professionals, clinical investigators, and customers.iqvia.com · 4 Oct 2026
- Sales and trial information
- IQVIA directs interested organizations to request a conversation through a contact form; the opened product pages did not state pricing or trial terms.secure.constellation.iqvia.com · 4 Oct 2026
- Company founding
- IQVIA’s company history says IQVIA emerged in 2016 from the union of IMS Health and Quintiles.jobs.iqvia.com · 4 Oct 2026
Company
- Company headquarters
- IQVIA lists its headquarters at 2400 Ellis Road, Durham, North Carolina 27703, USA.ir.iqvia.com · 4 Oct 2026
- Founded
- 2016iqvia.com · 28 Sept 2026
- Headquarters
- Durham, North Carolina, USAiqvia.com · 28 Sept 2026
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Sources
- iqvia.com/library/fact-sheets/smartsolve-complain· checked 4 Oct 2026
- iqvia.com/-/media/iqvia/pdfs/library/fact-sheets/· checked 4 Oct 2026
- secure.constellation.iqvia.com/SmartSolve· checked 4 Oct 2026
- ir.iqvia.com/resources/investor-faqs/default.aspx· checked 4 Oct 2026
- jobs.iqvia.com/en/iqvia-evolution-our-history· checked 4 Oct 2026
- iqvia.com/solutions/commercialization/quality-com· checked 28 Sept 2026