In Azierta, we have developed a new version of Vigilazierta, which today is validated and fully functional in R3 thus complying with all current requirements of the EMA.
R2 software will become obsolete. Therefore, it is necessary to adapt systems, which involves migration of cases and the development of software in R3 environment, aligned with Eudravigilance.
Vigilazierta is a validated and fully functional R3 data base which complies all current requirements of the EMA.
Vigilazierta provides a migration module that imports your cases in R3 automatically for a large volume of files with duplicate search included and fullfill with the following requirements.
- 100% Operational in R3
- R2 to R3 migration module
- Signal detection
- ISO ICSR/ICH E2B R3 Compliance
- MedDRA coding integrated
- Technical support by IT and PV specialists
- Intuitive and user-friendly interface
- Automatic reports generation
- Periodical updates with no extra cost
We are 100% aligned with the current European environment in PV and have the most functional and dynamic software, compliant with all EMA requirements.