IQVIA SmartSolve Complaint Management
Ranked in Quality Management Software ·No free plan on record
About
IQVIA SmartSolve Complaint Management is a cloud-based, AI-enabled platform for life sciences organizations handling 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 consistent investigation and reporting. Preconfigured workflows support reportability decisions for the FDA, EU, Health Canada, Japan, Australia, UK, and Switzerland, with electronic reporting requirements and integration to CDRH, MedDRA, and IMDRF codes. The described AI capabilities include language-processing extraction, generative assistance, automated triage, decision support, translation, and predictive analytics. Built-in reports and trends cover recurring complaints, resolution times, and historical data; Quality Intelligence uses Microsoft Power BI. SmartSolve can connect with nonconformance, CAPA, change management, and document management modules. Listed controls include role-based security, password authentication, and audit trails; the fact sheet also states ISO 27001 and ISO 9001 certification. Pricing is on request.
Who it is for
It suits life sciences quality teams responsible for complaint intake, investigation, regulatory reporting, and post-market surveillance. The intake portal is intended for field personnel and extended demand-chain partners, including healthcare professionals, clinical investigators, and customers.
What is good
- Multiple complaint intake channels are supported.
- Decision trees guide evaluation and reporting workflows.
- Reporting workflows cover seven listed markets.
- Connects with CAPA and other SmartSolve quality modules.
- Includes built-in complaint reporting and trending.
What to know first
- Pricing is available on request.
- No trial terms are stated.
- The listed product platforms are Android, iOS, and web.
Verdict
SmartSolve brings complaint intake, investigation workflows, reporting, and analytics into a connected quality platform. Organizations considering it need to request pricing and assess its fit with their reporting and module requirements.
Compared on quality management software
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