Regulatory reporting software

Regulatory reporting software helps in collecting data from systems of companies and produces regulatory reports by industry regulations. A regulatory reporting system helps in managing and automating the regulatory reporting and compliance processes of companies. Companies are competing globally by using regulatory affairs software to standardize and streamline regulatory submissions with R&D, quality, manufacturing, and clinical research. After launching a product in the market, preparation and submission of post-marketing reporting to different regulatory authorities can be done easily and fast by using regulatory reporting software.

Vistaar, a regulatory intelligence software helps in by providing customized regulatory requirements information for multiple countries, regulatory guidance documents, product approvals, and products that are in the clinical trials phase. Vistaar tool is built with Artificial Intelligence-powered search capabilities. It stores health authority documents and provides all guidance in one search. Vistaar tool provides easy-to-read flow charts based on the requirements of users. The tool can be integrated into EDMS or RIM systems with API and can increase the mileage of those other systems. Vistaar tool serves multiple industries  by providing data and intelligence in areas of Global Regulatory, Clinical, and Compliance Requirements to all sizes of companies to help product introductions and maintain ongoing global compliance.

Different types of regulatory reporting software’s in pharma are:

Oracle Argus software: Oracle Argus Safety is a platform designed to address the pharmacovigilance requirements of life science industry.  The software helps in faster data entry.

Arisg: Arisg is most used software in pharmacovigilance. It allows from case entry to automatic generation of submission ready adverse event reports.

Oracle AERS: Oracle AERS is a single global solution with powerful automation and productivity tools to meet the challenges of managing worldwide safety information. It helps to capture, manage, report and analyse serious adverse event and product compliance cases for all medical products including drugs, medical devices, vaccines, biologics and gene therapies.

PvNET: PvNET is a leading software used in pharmacovigilance which supports to segregate Data Entry, QC and scientific assessment/medical review, validate case files for E2B compliance.

repClinical: repClinical is a secure web based service that helps to manage critical pharmacovigilance activities like capturing adverse event data, generate regulatory reports and exchange ICSRs with multiple regulatory bodies and business partners. Data in repClinical models the data in the Individual Case Safety Reports (ICSRs). Case data can be stored and tracked in cases. Administrative and identification information of the case report can be stored and tracked in Safety reports.

MAXLife365: MAXLife365 allows quality control and quality assurance systems to work with each other and available for review and reporting. It enables to monitor product quality, proactively see and adapt to manufacturing uncertainty, meet GMPs, Sarbanes Oxley and 21 CFR Part 11 and Part 820 standards, and simplify computer system validation.