How Smarteeva Unified PSUR, PMSR, HSCR, and UK Reports on a Single Platform for a Global Diabetes Leader
A global leader in diabetes management devices needed a single platform for post-market surveillance reporting. Their product portfolio was large, and the manual reporting process had grown unmanageable. Each PMS report required nearly 50 manual steps. Report completion timelines stretched to almost a year. Product registration data, sales figures, and complaint records lived in separate systems with no connection between them.
Content creators had to plan and build each report from scratch. Data had to be collected manually from multiple sources, compiled into spreadsheets, and then formatted into report templates one section at a time. There was no way to work on multiple reports simultaneously.
Content users can now complete report reviews and submissions in minutes, replacing a 50-step manual process that previously took up to a year.
How Smarteeva Solved It
Smarteeva deployed its Unified PMSR Solution, integrating PSUR, PMSR, HSCR, and UK regulatory reports onto one platform.
Data flows automatically from Snowflake, SAP, and the company's RIMS server through direct API integration. No more manual data collection across systems. Content creators can now select and work on multiple reports at the same time, collapsing what used to be a year of sequential work.
Automated components handle the executive summary, footnotes, cover page, and conclusion with a single click. Timestamps and rich-text editing tools allow mid-report review and adjustment without breaking the workflow. IMDRF adverse event terminology is built in, with standardized, configurable templates across all report types.
Error messages alert users to missing information before submission, catching gaps that previously went unnoticed until regulatory review. Generated reports integrate with other software platforms for centralized document access. Following integration, content users complete report reviews and submissions in minutes.
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