PV Works - | Overview | >
Specification |
PV Works - Drug Safety Software Specification
PV-Works drug safety software provides comprehensive data entry and reporting,
full audit trail, links to Microsoft Office and image and document management.
The pharmacovigilance database has been designed around the ICH E2B guideline such that every
E2B data field maps to a specific database field. An electronic reporting
function is included and coding to MedDRA is simple.
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
- Workflow fully integrated with safety functionality and data handling
- Uses established third-party workflow engine
- Follow-ups controlled via workflow
- Escalation procedures
- Process health check / performance reports
- Management functions including workload balancing
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Pharmacovigilance Functionality
- ICH compliance by design including E2B reporting
- Collect and report safety data to meet all common international regulations
including FDA, CIOMS, EMEA, MHRA, AFM, BfArM
- Code against standard dictionaries including current MedDRA
- Extensive data validation, cross-field validation checks and use
of pick lists
- Duplicate check
- Integrated document management
- FDA 21 CFR Part 11 compliance
- Health Canada report and CERFA
- Medical Devices
- Built-in query tool
- Data export function
- Easy to use screens
- Integrated spell-checker
- Notes may be added to any case
- Full audit trail
- Mandatory fields
- Letter generation
- Case Distribution system to send case to local offices
- Open database for use of third-party query and reporting tools
- Extensive use of reference dictionaries, eg contacts, lab tests
- 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 servers
- 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 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
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