Ennov pharmacovigilance suite
Veterinary Pharmacovigilance Software
- VICH complaint PV database
- Simplified VeDDRA coding
- Paper and electronic reporting formats
- Workflow driven
- Powerful querying and analysis tools
- Used by leading animal health companies and key regulatory authorities
The Pharmacovigilance Challenge
Developing or implementing a system to collect, manage, report and evaluate patient safety data can be time consuming and expensive. Companies of all sizes need a system that is compliant with global regulations, easy to access and use, fast to implement, and simple to maintain. The system must be affordable, allowing companies of all sizes to bring on board a high-quality solution that is cost effective for managing their current caseloads, while also capable of growing with their business.
An ideal system would be flexible, could integrate with other databases, and is designed to manage not only adverse events from clinical trials or occurring spontaneously in the field but could also manage medical inquiries and product quality complaints for all medical products, including traditional pharmaceuticals, biomedical products, medical devices.
A Comprehensive Veterinary PV Data Management Solution
PV-Works Vet is a flexible software system designed to support animal health/veterinary pharmacovigilance business processes and technical services case handling practices, while 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 ensures 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.
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.
- Flexible user defined graphical process maps to reflect business practice
- ‘To-do’ list drives process task execution, prioritized by lateness, seriousness, etc.
- Workflow is fully integrated with safety functionality and data handling
- Management functions including team supervision and workload balancing
Advanced Capabilities Ensure Compliance
PV-Works Vet submits electronic reports of animal health data to the EMA and all EU Competent Authorities using the EUVeterinary XML format, as well as the HL7 compliant XML schema that is required by FDA CVM and is defined by VICH.
PV-Works Vet is easily integrated with standard AS2 gateway software to manage electronic submissions. Acknowledgement messages and batch submissions are comprehensively handled.
The import of compliant XML formats is also fully supported, allowing receipt of cases submitted to industry directly from European Competent Authorities. The import function is also implemented by Regulatory agencies using PV-Works Vet upon receipt of electronic submissions from industry.
The PV-Works Vet electronic reporting function is updated in line with regulatory changes. In addition to working closely with the FDA CVM, Ennov also participates in the EMA E-reporting Implementation Group.