This solution improves product safety and regulatory compliance by streamlining complaint intake, tracking, and resolution. IQVIA SmartSolve Complaint Management centralizes processes, automates workflows, and ensures consistent categorization of issues. It supports compliance with FDA 21 CFR Part 11 and EU Annex 11 by maintaining secure, auditable records. Features include electronic complaint submissions, automated routing to relevant teams, integration with CAPA for escalations, and real-time dashboards to monitor status and trends. The module helps manufacturers minimize product risks, accelerate resolutions, and meet global regulatory requirements, while also providing insights into systemic quality issues for continuous improvement.

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