Enabling Safety of Drugs, Vaccines, Devices and Cosmetics
Global medical device leaders have been adopting 3Analytics for IMDRF coding for upstream needs followed by downstream signal detection to comply with the EU MDR regulations. The algorithm codes both device complaints and MedDRA codes for associated adverse events in addition to Annexure E of IMDRF coding. This is now being integrated into multiple QMS systems in the industry namely Catsweb (AssurX) and Trackwise (Sparta Systems-Honeywell).
The AI Platform automates this data conversion process and integrates with an algorithm driven Signal Detection and Management application, meeting new guidelines- reliably and cost effectively.
This integrated solution offers an easier pathway, reducing the noncompliance risks. It becomes even more critical for big manufacturers who may have a large legacy data set and hence manual conversion may not be an option.
© 2023 I&I Software. All Rights Reserved.