One Link, Infinite Ease: Smarteeva's One-Link Complaint Management

The company, known globally for its cutting-edge orthobiologics and active healing solutions, struggled to overcome quality process complexities caused by manual operations and an outdated, non-GenAI-enabled eQMS system for Post-Market Surveillance.

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Smarteeva replaced three disconnected software solutions with one integrated system, simplifying complaints management.

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The Challenge

Three disconnected systems, manual complaint filing, no scalable intake process

• Tracking and analyzing information changes made it harder to make informed regulatory decisions
• Prior QMS system required multiple steps to navigate the complaint lifecycle
• Using CRM cases to manually file complaints was impractical in cost and scalability
• Users outside the Salesforce system had no way to submit complaints directly

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How Smarteeva Solved It

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

1. Dedicated URL for complaint submission: no login required, accessible from anywhere
2. One-click redirect to a no-login web interface that captures all required complaint information
3. LLM-powered auto-completion of complaint forms from URL-submitted user input
4. Unlimited file upload capability (unlike the CRM which had size limits)
5. Fully automated MDR reporting: creation, completion, and FDA submission in minutes
6. AI-driven Decision Trees and notification alerts for incomplete information
7. Similar Complaints tool using AI to locate records with shared issues and products