SMARTVIGISCREEN is a cloud-based software solution that processes incoming ICSRs automating the analysis of company vs non-company cases and taking away manual efforts. The tool is GxP validated system according to GAMP 5 guidelines and CFR Title 21 Part 11 compliant. Moreover, SMARTVIGISCREEN is fully validated for both EVW and MLM download process and can easily be integrated with ICSR Management process, generating up to 70% efficiency increase.