Minimize the hassle and improve compliance with effortless adverse event management
Our easy access from any device, smart audit trail, and e-signatures
have been designed with you in mind
have been designed with you in mind
Streamline Adverse Events with Smart AI
Handling adverse events is seamless with Smarteeva. Our logic-based AI decision trees evaluate case severity and suggest next steps quickly. Use our complaint templates to address recurring issues promptly, and rely on Smarteeva’s AI for accurate MDR reports that meet global compliance standards.
Are you looking for an Adverse Event Management solution that not only ensures compliance with regulatory authorities but also streamlines your processes? Look no further than Smarteeva. Our best-in-class solution features industry-leading smart audit trails and meaningful data change features, making follow-up reporting a breeze. With pre-populated FDA and EUMDR codes and single-sign on e-signatures, you can approve on the go with ease.
Smart decision trees
Our advanced decision trees provide an intelligent and systematic approach to identify reportable events with precision and accuracy. This provides an effective method to determine the type of event and its corresponding due date, leaving no room for error.
Pre-populating common data
Pre-populating data such as manufacturer information, and leveraging pre-set and widely-used language is a game-changer. Our focus is on empowering our users to produce well-crafted responses to agencies instead of wasting precious time on tedious data entry.
Cutting-edge data management system
Now you can be confident that you are meeting the deadlines for adverse event management. Our smart audit trail simplifies the process of submitting supplemental or follow-up reports, freeing up valuable time and resources for more crucial tasks.
Access all relevant information in one place
We integrate our adverse event management and reporting system with the complaints management system, allowing you to spend less time searching for data, and more time focused on taking action.
Track all changes in adverse event records with ease and efficiency
Our system tracks all the meaningful data changes across related adverse event records. You'll be able to easily see what information has changed during investigations or complaints directly from the complaints screen.
Generate regulatory reports effortlessly with custom reports
We offer the ability to create XML and PDF reports for regulatory agencies, including EUMDR, MDR, Canada, and more. And if you need additional reports, we can create them for you.
Stay up-to-date with crucial regulatory codes
All MDR and EUMDR codes are included in our system, and we update them every time the regulatory agencies send changes or additions.
Streamline data entry and focus on crafting the perfect message
Our system allows you to manage reusable data such as manufacturer information, reporter information, or importer information separately. This means less time spent on data entry, and more time spent crafting the perfect message to regulators.
Optimize data entry with smart decision trees
Our sophisticated decision trees make it easy to manage decisions about report type, due date, and other critical information. This leads to more efficient data entry and a more streamlined process overall.
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Any device access
Use Smarteeva from anywhere, on any device
Industry leading
Advanced features including machine learning and smart audit trail
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Optimize your adverse event management process
Tired of spending hours on manual data entry and paperwork for adverse event reporting? We’re here to help!
