ARS PV

ARS PV - Advance reporting System is software solution that offers complex data analysis and querying of safety data sets, meeting all the global regulatory requirements, while ensuring high quality standards and compliance.

ARS PV

Features of ARS PV

▪ Innovative dashboard tool for measuring ICSR compliance and it’s expeditedness

▪ Follow up module for tracking all follow ups and sets reminders according to in-built escalation rules till case closure

Followup Module for Tracking
Managing multiple MedDRA

▪ Managing multiple MedDRA version , its upgrade and impact analysis MedDRA version upgrade impact analysis

▪ Compliant with 21 CFR part 11 of US FDA ,GDPR, Annexure 11 of EMEA ,ICH GVP guidance like E2B R2 & R3 and GAMP 5 for computer system validation.

▪ Support Medical Drug dictionary and Medical Event Dictionary like (Drug Dictionary, WHO –Drug Dictionary and MedDRA).

▪ Enabling User with safety field specifications and user friendliness

Enabling User with safety