Assured Information Systems

PV-Works: Pharmacovigilance Software System

PV-Works meets all international regulatory requirements, including ICH E2B electronic submission and is scalable from PC to corporate network. At the same time PV-Works can implement your business process ensuring SOP compliance and on-time reporting.


PV247: Try PV-Works FREE for 30 days

You can evaluate the human and veterinary versions of PV-Works via our comprehensive online solution, PV247, FREE for 30 days. PV247 uses the same PV-Works or PV-Works Vet software that is shared by all our implementation models – local installation and hosted web-based solutions. You can create a fully functional account in minutes and start processing cases within an hour. Read more at →

General Software Description

The functionality of PV-Works ensures that you can capture and report safety data in full compliance with ICH Guidelines, creating PSURs, DSURs, XML e-reports as well as CIOMS and MedWatch 3500s.

Quality is built in with full FDA 21CFR Part11 compliance and a fully integrated audit trail. Similarly all data is secure in its Oracle database with access permissions set according to role.

A comprehensive query tool and reports library deliver analysis, summary and review capabilities as well as surveillance needs for smaller data volumes.

Workflow Based Pharmacovigilance

PV-Works is a process driven system. A purpose-built workflow engine, is integrated with comprehensive safety functionality in order to provide management control of pharmacovigilance processes.

Specifications →