PV Works (vet) - | Overview
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PV-Works (vet) Veterinary Drug Safety Software Specification
PV-Works (vet) veterinary drug safety software provides comprehensive data
entry and reporting, full audit trail, links to Microsoft Office and image
and document management.
As part of the application, Document Management functionality allows source
documents and images of regulatory reports to be stored and retrieved with
the case itself.
Process Driven Pharmacovigilance
- User defined graphical process maps
- 'To do' list drives process execution
- 'To do' list prioritised by lateness, seriousness
- Fully integrated with safety functionality / data handling
- Uses established third-party workflow engine
- Auto-completion of tasks
- Web-based
- Escalation procedures
- Process health check / performance reports
- Management functions including workload balancing
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Pharmacovigilance Functionality
- Collects and reports data to meet all common international regulations
including FDA, Fedesa / CVMP, EMEA, European states, Australian
- Coding of cases against user dictionaries
- Extensive data validation, cross-field checks and use of pick lists
- Handles animal reactions, human exposures, lack of efficacy and
product complaints
- 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 using Microsoft Word
- Open database for use of 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
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Technical
- Scalable from single PC to corporate client / server network
- Internet access
- Oracle database
- UNIX / Windows NT / 2000 server
- Windows 98 / NT / 2000/ XP clients
- Citrix Metaframe compatible
- RAD development technology
- Interface with Microsoft Office
- Interface with Crystal Reports
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Back to: PV Works (vet) Veterinary
Pharmacovigilance Software
Assured Information Systems Ltd, 5 Eaton Court Road Colmworth
Business Park Eaton Socon St Neots PE19 8ER England. Telephone +44 (0) 1480
212223 Fax: +44 (0) 1480 216495
