As a result of Abbott’s recent business separation decision, Abbott EPD has established an independent pharmacovigilance (PV) unit. In order to ensure that both Abbott EPD and AbbVie are able to fully comply with all regulatory requirements related to adverse events reporting, it was necessary to implement separate PV systems and associated support functions.

The project consisted of several major steps:
1. Cloning AbbVie’s PV environment (ARISg) and subsystems (PV-Track, IRT, Oracle Empirica)
2. Configuration changes
3. User Acceptance testing
3. Business- and IT-SOP review and modification
4. Setting-up required support functions

VOEGELIN system engineering was providing the project-management for Abbott EPD and the coordination of go-live tasks with Abbott Nutrition.