Fully automated eMDR transmission
Our software solution revolutionizes the eMDR process through complete automation from the first step of data collection to the final FDA confirmation. Companies do not need HL7 know-how, XML knowledge or the FDA eSubmitter tool.
The first step of our solution replaces complex XML creation with a user-friendly Excel template. This prefabricated, FDA-compliant ICSR template enables specialist departments such as Regulatory Affairs, Quality Assurance, Vigilance or Medical-Scientific Affairs to enter their case information in a structured and intuitive manner without having to deal with the technical complexity of the HL7 format. And that regardless of whether it is an “Advers Event Reporting” and / or “Product Problem” .
Automatic conversion and shipping is the second step of our solution. Our application reads the completed Excel template and generates a valid HL7 ICSR XML file that exactly meets the FDA XSDschema requirements. The transmission takes place fully automatically via an M2M (Machine-to-Machine)connection via ESG Submission Gateway, making manual uploads a thing of the past.
Automatic ACK management is the third component of our solution. The confirmations returned by the FDA (ACK1 to ACK4) are automatically received, evaluated and interpreted. The system automatically detects whether these are success, error or warning messages. This information is clearly forwarded by e-mail to the responsible employees – in the desired form – ensuring a timely response to any problems.
Advantages of automation
The result is a 100 percent digital and FDA-compliant workflow that offers significant advantages over the manual process . The drastic time savings from originally 30-45 minutes per case to just a few minutes allows companies to use their resources more efficiently. The minimized risk of error through automatic validation significantly reduces the likelihood of report rejections. The scalability of the solution makes it particularly valuable for companies with growing reporting volumes, as the degree of automation remains constant, regardless of the number of cases to be processed.In addition, full compliance with FDA requirements ensures that all regulatory requirements are met, while auditable documentation of all processes ensures the traceability and transparency essential for regulated industries. This combination of efficiency, security, and compliance makes automated eMDR delivery a strategically important investment for medical device manufacturers operating in the U.S. market.
Tags: FDA Forms 3500A, FDA Forms 3500B, eMDR, HL7, M2M, ESG WebTrader, MedWatch, ACK, Advers Event Reporting, ICSR, eSubmitter, Acknowledgment