FILTRYX - Triage Solution for ICSR Cases

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Peter Muss

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Filtryx in Day to Day Practice

Filtryx offers a solution for reliable, validated, and efficient Triage based on the customisation of your own Marketing Authorisations and Marketing Status of your Products in all concerned EU countries while at the same time providing full documentation of your search itself and the Triage Results:

· Processing of the entire batch of downloaded ICSR in one single step within less than 1 minute

· Displaying the Worldwide unique case identification number together with the EV Human number identifying the ICSR

· Automated assessment based on the customised Marketing Authorisations and Marketing Status of your Products:

· Displaying all ICSRs for which case ownership cannot be excluded and requiring to be processed in the MAH's Safety Database and the concerned suspected product substance

· Displaying the applicable exclusion criterion for all ICSRs that can be excluded and the product

· Displays Trade names and Lot/Batch numbers detailed in the potential ICSR

· Allows for adjustment of the automated assessment for specific reasons and the documentation within one step

· Real time One Click access to the HUMAN READABLE (HTML) view for each ICSR for assessment of more details, if required

· Serves as audit-proof documentation through export function as PDF document and/or in Excel format to be archived according to your business policies

· Allows for direct import of the ICSR selected for further processing into your Safety Database Application

· As it represents a validated automated process, double verification is no more necessary

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