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IQVIA SmartSolve Complaint Management

iqvia.com

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Spec score 8.2 #4 of 16 in Pharma CRM Software

What it is

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.

Spec sheet

What it does
SmartSolve Complaint Management is an AI-enabled life-sciences system for complaint intake, investigation, regulatory reporting and post-market surveillance.Read 15 Oct 2026 · iqvia.com
Purpose
The AI-powered solution is for life sciences organizations managing global complaints, regulatory reporting, and post-market surveillance.Read 4 Oct 2026 · iqvia.com
Intended users
The Quality intake portal is intended for field personnel and extended demand chain partners including healthcare professionals, clinical investigators, and customers.Read 4 Oct 2026 · iqvia.com
Deployment
IQVIA documentation describes both cloud and on-premise SmartSolve deployments.Read 15 Oct 2026 · iqvia.com
Headquarters
Durham, North Carolina, USARead 28 Sep 2026 · iqvia.com
Founded
2016Read 28 Sep 2026 · iqvia.com
AI features
The fact sheet describes NLP extraction, generative AI assistance, automated triage, decision support, translation, and predictive analytics.Read 4 Oct 2026 · iqvia.com
Analytics
Built-in trending covers recurring complaints, resolution times and historical data, with Quality Intelligence delivered through Microsoft Power BI.Read 15 Oct 2026 · iqvia.com
Authentication
The help documentation says login uses centralized Active Directory authentication and requires password re-entry for sign-offs and approvals.Read 15 Oct 2026 · bioventus.pilgrimasp.com
Automated triage
AI prioritizes incoming complaints by risk, urgency and regulatory requirements.Read 15 Oct 2026 · iqvia.com
Cloud platform
The complaint-management fact sheet identifies SmartSolve as an Azure-based platform.Read 15 Oct 2026 · iqvia.com
Company founding
IQVIA’s company history says IQVIA emerged in 2016 from the union of IMS Health and Quintiles.Read 4 Oct 2026 · jobs.iqvia.com
Company headquarters
IQVIA lists its executive headquarters in Research Triangle Park, Durham, North Carolina.Read 15 Oct 2026 · sec.gov
Company legal name
The SEC filing identifies the maker as IQVIA Holdings Inc., a publicly traded company listed on the NYSE under IQV.Read 15 Oct 2026 · sec.gov
Company origin
IQVIA’s LinkedIn company information lists 2016 as its founding year.Read 15 Oct 2026 · linkedin.com
Company size
IQVIA reports approximately 93,000 employees operating in more than 100 countries.Read 15 Oct 2026 · sec.gov
Complaint evaluation
Configurable decision trees distinguish complaints and adverse events from other inquiries and guide consistent investigations.Read 15 Oct 2026 · iqvia.com
Complaint volume
IQVIA says SmartSolve has managed more than 26 million complaints since inception.Read 15 Oct 2026 · secure.constellation.iqvia.com
Compliance controls
The platform provides two-part electronic signatures, audit trails and computer-system validation support for 21 CFR Part 11 and EU Annex 11.Read 15 Oct 2026 · iqvia.com
Configuration
Studio Designer allows forms, decision trees and process logic to be tailored without code.Read 15 Oct 2026 · iqvia.com
Decision support
Decision-support tools recommend investigation routes and regulatory actions using decision trees, historical data and current insights.Read 15 Oct 2026 · iqvia.com
Enterprise integrations
SmartSolve APIs are described for connecting CRM, ERP, LIMS, MES and PLM infrastructure.Read 15 Oct 2026 · iqvia.com
Generative AI
Generative AI finds similar records and drafts information-chase letters and investigation summaries with a human reviewer involved.Read 15 Oct 2026 · iqvia.com
Global reporting
Preconfigured reporting logic covers FDA eMDR, EU MDR and IVDR, Health Canada MDPR, Japan ARR, Australia MDIR, UK and Swiss MIR processes.Read 15 Oct 2026 · iqvia.com
Hosting
The fact sheet describes SmartSolve as an AI-enabled, Microsoft Azure-based platform.Read 4 Oct 2026 · iqvia.com
Intake
Complaint data can enter through web forms, a secure Quality intake portal, ERP or CRM integrations, web portals, and IQVIA Vigilance Detect.Read 4 Oct 2026 · iqvia.com
Intake channels
Intake supports web forms, a secure quality portal, ERP or CRM feeds, customer web portals and IQVIA Vigilance Detect social-media monitoring.Read 15 Oct 2026 · iqvia.com
Limit: implementation
A Gartner review reports programming bugs and implementation teams that sometimes introduced additional bugs while fixing earlier ones.Read 15 Oct 2026 · gartner.com
Limit: notifications
Gartner reviewers say NCR notifications and document-training emails may be difficult to manage, with links not always opening the intended document.Read 15 Oct 2026 · gartner.com
Limit: performance and support
G2 reviewers mention slow speed, cumbersome asset management and customer support that is basic or slow to resolve issues.Read 15 Oct 2026 · g2.com
Limit: usability
Reviewers report that workflows can be complex, unintuitive and difficult for employees to learn.Read 15 Oct 2026 · capterra.com
Module integration
Complaint Management connects with SmartSolve Nonconformance, CAPA, Change Management and Document Management modules.Read 15 Oct 2026 · iqvia.com
Natural-language processing
NLP extracts information from free-text complaints, social-media content and third-party sources to speed case creation.Read 15 Oct 2026 · iqvia.com
Praise: configurability
Reviewers describe SmartSolve as flexible to configure and adaptable to organizational requirements.Read 15 Oct 2026 · gartner.com
Praise: document control
Reviewers praise centralized document storage, easy searching, version traceability and training or SOP management.Read 15 Oct 2026 · gartner.com
Praise: integrations
A G2 reviewer highlights integrations with other platforms, customization, dashboards, role management and single sign-on.Read 15 Oct 2026 · g2.com
Predictive analytics
Machine-learning models detect complaint patterns and trends so organizations can address recurring quality problems.Read 15 Oct 2026 · iqvia.com
Quality modules
Complaint Management connects with SmartSolve Nonconformance, CAPA, Change Management, and Document Management modules.Read 4 Oct 2026 · iqvia.com
Rating on Capterra
4.2 out of 5 from 11 reviewsRead 15 Oct 2026 · capterra.com
Rating on Gartner Peer Insights
4.1 out of 5 from 9 reviewsRead 15 Oct 2026 · gartner.com
Rating on GetApp
4.2 out of 5 from 11 reviewsRead 15 Oct 2026 · getapp.com
Rating on Software Advice
4.2 out of 5 from 11 reviewsRead 15 Oct 2026 · softwareadvice.com
Regulatory code integration
The product supports electronic-reporting connections to CDRH and coding standards including MedDRA and IMDRF.Read 15 Oct 2026 · iqvia.com
Regulatory reporting
Preconfigured decision trees support reportability workflows for FDA, EU, Health Canada, Japan, Australia, UK, and Switzerland.Read 4 Oct 2026 · iqvia.com
Reporting integrations
The fact sheet says the system supports electronic reporting requirements and integration to CDRH, MedDRA, and IMDRF codes.Read 4 Oct 2026 · iqvia.com
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.Read 4 Oct 2026 · secure.constellation.iqvia.com
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.Read 4 Oct 2026 · iqvia.com
Security certification
IQVIA states that SmartSolve is ISO 27001 certified and that its quality platform also holds ISO 9001 certification.Read 15 Oct 2026 · iqvia.com
Translation
Translation assistance lets users read quality records and complaint information in their local language.Read 15 Oct 2026 · iqvia.com

Plans and prices

Custom quote Priced on request Subscription pricing available on request Enterprise QMS, complaint management, regulatory, supplier and risk modules · implementation and integrations quoted separately Read 15 Oct 2026 · capterra.com
SmartSolve Complaint Management Priced on request Pricing not published; IQVIA invites prospective customers to contact sales Read 4 Oct 2026 · secure.constellation.iqvia.com

Every IQVIA SmartSolve Complaint Management plan and price →

Strong points and limits

Strong points

  • 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

Limits

  • Pricing is not published
  • Opened product pages did not state trial terms

Who it suits

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.

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.

Where Specifiction places it

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