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PV Works - Pharmacovigilance Software System

PV-Works is the first process-driven pharmacovigilance software system that meets all international regulatory requirements, including ICH E2B. Scaleable from PC to corporate network, PV-Works implements your business process ensuring SOP compliance and on-time reporting.

PV Works

General Software Description

The functionality of PV-Works ensures that you can capture and report safety data in full compliance with ICH Guidelines.

By using the fully integrated workflow functionality, you can be confident that critical reporting deadlines will be met and SOPs will be followed.

Submitting reports electronically couldn't be easier. Optionally, integrate your Inquiry and Complaint Management and/or Product Defect Tracking with your Adverse Event reporting.

Workflow Based Pharmacovigilance

PV-Works is a process driven system. A commercial workflow engine, W4, is integrated with comprehensive safety functionality in order to provide management control of pharmacovigilance processes.

PV Works Screenshot

Key Features

Flexible data entry
Data field validation at point of entry including range checks and cross-field checks
Product match function to identify other cases reported against the same batch
Submission of Regulatory Reports

Next: Specification of PV Works Drug Safety Software

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