Built on Salesforce and Google Cloud
Post Market Surveillance Suite
Smarteeva believes strongly that Post Market Surveillance is one of the most underinvested areas of a Medical Device Company and it has the opportunity and the potential to make a big difference in a company’s performance both from a customer satisfaction perspective but also from a product quality and regulatory compliance perspective. See our solutions
Smarteeva’s Intake and Complaint Solution provides the next generation of complaints management by fully integrating risk management and customer self service. Utilizing embedded Artificial Intelligence, the solution lets you collect all necessary and complete initial complaint data, followed by the ability to run automated risk assessments to help determine the level of risk associated with the complaint. Furthermore, leveraging machine learning capabilities, the solution guides the users through the right investigation and assessment path to ensure a complete feedback loop and compliance with regulatory authorities such as FDA, EU, PMDA, TGA etc.
Field Notice Mgmt
Field Notification Management simplifies the process of creating and sending Safety, Quality, Recall, Service and other Notices to the customers, affiliates and distributors. By utilizing smart cloud technology, Smarteeva is able to track complete lifecycle of the Notice generation through review and approvals and smart audit trail. It then links to the Install Base and generates the list of notice receivers who are automatically notified and asked to fill out a feedback form acknowledging the notice receipt and capturing any additional info.
Adverse Event Mgmt
Adverse Event tracking and reporting is a very important function for any life science company. Smarteeva simplifies this process by integrating it with Complaint Handling and ERP. Utilizing our smart business rule configuration Smarteeva is able to automatically fill out most information so that regulatory staff can spend their efforts in crafting the right message to the agencies rather than doing data entry. Using Smart Audit Trail and Meaningful Data Change, Smarteeva is able make changes easily visible so follow up/supplemental reports can be triggered.
How many times have customers asked your clinical or account representatives about the status of a complaint? They will never have to ask again because it is available to them via the customer portal.
Increased Customer Engagement
Today’s customers have the ability to communicate with life science companies via multiple channels. Having a portal and mobile presence allows life science companies to bring the regulated processes into the digital age and give choice to their customers to better communicate with them about recalls, complaints, notifications, service contracts, troubleshooting and investigations.
Better Data Quality
Utilizing industry leading features such as client side validation checks, smart audit trail, sophisticated decision trees and machine learning, Smarteeva leads the industry in features, functionality and business support.
Built on the secure Salesforce Platform Smarteeva offers both encryption on transit and encryption at rest. This is in addition to all the detailed and granular access rights that can be provided to users.
Simplicity and Flexibility
Easy to use and flexible systems allow for better compliance. Smarteeva, from its Platform to Intake and Complaints to Recall management and Risk management is built to allow for ease of use of extreme flexibility. Business process change over time and we want to make sure that your system matches your process rather than vice versa.
Processes like Investigations, Intake, Notification Feedback and Risk Assessments require for Consistency of data collected in order for them to be effective and truly data driven and digital. Smarteeva recognizes that and was built from the ground up with the goal of consistent data collection and analysis.
POST MARKET SURVEILLANCE