PV-Works Vet: Animal Health / Veterinary Pharmacovigilance Software
PV-Works (vet) is used by the leading animal health companies to record, report and analyse adverse events. In addition a number of key regulatory authorities have implemented the software to capture and analyse report submissions from industry, the general public and other sources. Optional modules may also be used for product defect tracking and query / complaint handling.
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General Software Description
PV-Works (vet) is a flexible software system designed to support animal health / veterinary pharmacovigilance business processes and technical services case handling practices, whilst meeting the associated company safety and world-wide regulatory reporting requirements.
In addition to simple yet comprehensive data entry and reporting functions, the fully integrated workflow functionality will ensure SOP compliance and that critical reporting deadlines are met. Regulatory compliance is afforded with the adherence to key requirements such as FDA 21 CFR Part 11 and the provision of a full audit trail.
Workflow Based Pharmacovigilance
PV-Works (vet) 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.