From 100+ Hours to 8 Hours: How Smarteeva Automated PMS Report Generation for a Global Diagnostics Leader

A global biotech leader and one of the world's largest in-vitro diagnostics providers was spending over 100 hours on every post-market surveillance report. Planning and risk assessment cycles stretched to six months. Sales data, incident records, and complaint information sat in separate systems with no centralized view. Teams tracked report assignments in Excel, managed reviews through email chains, and dealt with conflicting document versions across departments.

The legacy reporting platform could only pull from FDA databases, forcing manual searches for competitor device data and international regulatory intelligence. Every organizational change triggered a cascade of manual reassignments. Report generation was not just slow. It was structurally broken.

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Where manual processes once consumed 100+ hours across disjointed emails, conflicting versions, and error-prone spreadsheets, Smarteeva now delivers identical outcomes in just 8 hours with 95% automation and complete digital audit trails.

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How Smarteeva Solved It

• Smarteeva automated the complete PMS report generation lifecycle for PSUR, PMSR, SCSR, and PMPFR reports.
• The platform built a single-view map showing all product approvals across the UK, Canada, and Europe using real regulatory data. An intelligent classification engine matches products to EU risk categories (A, B, C, D) based on predefined regulatory rules and calculates reporting frequency automatically.
• Project plans are auto-generated seven days before they are needed, giving teams structured review time without manual scheduling. Critical metrics are extracted directly from the company's Snowflake data warehouse: sales volume, serious incident reports, CAPA records, and complaint data. No manual data collection required.
• Empty report sections are auto-filled with compliant default text and auto-closed, reducing effort for content creators. Executive summaries, key findings, and conclusions are dynamically generated through rule-based automation. A two-step approval process with digital signatures, rejection workflows, and section-level corrections replaced the email-based review chain.
• PMPFRs are auto-generated 13 days before the project start date, with smart sync that keeps reports updated as projects evolve.

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