Ennov PV-Works (vet)
Animal Health / Veterinary Pharmacovigilance Software
PV-Works (vet) is used by the leading animal health companies worldwide to record, report and analyze adverse events. In addition a number of key regulatory authorities have implemented the software to capture and analyze report submissions from industry, the general public and other sources. Optional modules may also be used for product defect tracking and query / complaint handling.
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.
Benefits of PV-Works (vet) solution
- Industry standard – proven software used by leading animal health companies and key regulatory authorities
- Validated solution – fulfill requirements of internal and external regulatory audit
- Ensure compliance – generate regulatory compliant outputs both in paper and electronic format
- Structured data collection – (including validation at the point of entry) to improve later trending and analysis
- Integrated solution – capable of handling pharmaceutical, biological, pesticide and nutraceutical pharmacovigilance as well as managing product defects and technical enquiries
- Trending and analysis – powerful and flexible functionality built-in
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.
- Flexible user defined graphical process maps to reflect business practice
- ‘To-do’ list drives process task execution, prioritized by lateness, seriousness etc
- Workflow fully integrated with safety functionality and data handling
- Management functions including team supervision and workload balancing
Query Based Pharmacovigilance
PV-Works (vet) includes a wide range of powerful querying functionality, allowing business teams to monitor case handling, track compliance, and execute in-depth trend analysis.
- Comprehensive data querying and powerful analysis
- Direct data export to Excel
- Management reports built-in
- Available as cloud based solution – see www.pv247.com
- On-site deployment scalable from single PC to corporate solution
- Oracle database on Windows / UNIX / Linux servers
- Compatible with Citrix, 2X, Windows RDP and other thin client middleware
- Agile development methodology
- Interface with Microsoft Office
- Interface with Crystal Reports
Electronic Reporting to the EMA and FDA with PV-Works (vet)
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 automated 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.
- Query functionality: User-friendly query tools which make it easy to explore and understand your data
- Case approval concept: Straightforward case review and data approval concept, to ensure quality of regulatory output
- Flexible workflows: Easy to configure process flows that match existing business processes
- Customer support: Experienced and knowledgeable support team on-hand to help you get the best out of your implementation and configuration
- Collects and reports animal health safety data to meet all common international regulations including FDA, EPA, CVMP, EMA, European states, Canada, Australia, South Africa
- Coding of cases against current VeDDRA dictionary
- Extensive data validation, cross-field checks and use of pick lists
- Handles animal reactions, human exposures, lack of efficacy, other adverse events, technical enquiries and product complaints
- Comprehensive QA product defect investigation module also available
- Duplicate check function
- Integrated spell-checker
- FDA 21 CFR Part 11 compliance
- Case data export
- Notes may be added to any field
- Full audit trail
- Letter generation
- Tools to record product replacement and financial re-imbursements
- Database may be used with third-party query and reporting tools
- Extensive use of reference dictionaries, e.g. contacts, laboratory tests
- Integrated document management
- Built-in query tool
- Handles user time zones in a global implementation
Cloud-based or On Site
Ennov PV provides a comprehensive solution to the management and reporting of human and veterinary adverse events.
Remote safety data capture.
PDF file or dynamic browser-based web form.
Web based pharmacovigilance case data entry.
Efficient and configurable web interface. Speech to text.
Complete pharmacovigilance database with configurable workflows and reporting.
Signal detection and analysis.
Out-of-the-box use by business users.
Broad array of statistics. Powerful data cubing and visualisation.
Why Choose Ennov ?
Complete pharmacovigilance solution
- Comprehensive features
- Intuitive case entry
- Validation workflows
- Reporting to authorities
- Advanced analysis
- Manage any product type
- Human drugs
- Pharmaceutical drugs
We respect your freedom of choice
- Available as cloud or on premise. You can switch between options at any time.
- If cloud based we offer single-tenancy to minimize version upgrade risks and validation upgrades. Data are hosted locally for total flexibility, improved security and optimized performance.