Smarteeva Automates Risk Assessment for a Leading Insulin Delivery Manufacturer

A leading manufacturer of insulin delivery systems needed its risk management file to keep pace with its complaint data. Hazards, occurrence estimates and control measures were maintained by hand, and the effort involved set how often the work could happen at all.

A risk assessment that took several weeks of manual work now generates in 8 minutes, across roughly 700 hazards and more than 320 product categories.

The Challenge

Manual risk assessment in Excel and Word, several weeks per report, roughly 30 reports a year

•  Manual by construction: complaint data was filtered and aggregated in Excel, calculations were performed there, and the final report was assembled in Word
• Scale made it slow: around 700 hazards across more than 320 product categories, each needing its occurrence estimate checked against real-world evidence
• Frequency was set by effort: several weeks per report meant roughly 30 reports a year, so cadence reflected available time rather than risk
• The denominator sits elsewhere: occurrence is a rate, and unit volumes live in ERP and sales systems rather than the quality system
• Errors are invisible at volume: the same judgment call repeated several thousand times is where quiet inconsistencies accumulate.

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How Smarteeva Solved It

Smarteeva partnered with the customer to design and deploy a purpose-built solution:

1. Hazards became records. Hazards, hazardous situations and intended use moved into the platform as objects, alongside complaints, investigations and adverse events, so a complaint can point at a specific hazard
2. IMDRF Annex codes carry the mapping. The coding already performed for regulatory reporting now assigns hazard and severity, so classification work does double duty as risk evidence
3. Exposure data comes from the source. Install base and distribution volumes are drawn from the systems that hold them, converting complaint counts into occurrence rates that can be compared against what the risk file assumed
4. Nine orchestrations run the analysis. Smarteeva Orchestra executes more than 250 configured steps against the customer's own risk file, from scoping and calculation through root cause and hazard conclusion
5. Smart Documents applies the customer's report template. AI drafts the narrative sections from the assembled evidence, and a qualified reviewer approves, edits or rejects before anything is issued.