In Part II of ARITHMOS‘ article series on pharmacovigilance best practices, we address the need of project implementation and maintenance by introducing the Consortium initiative which helps companies significantly reduce costs while receiving expert advice from cross-functional teams.
In order to facilitate the implementation, production and maintenance phases of a pharmacovigilance system migration project, ARITHMOS has introduced a consortium for the provision of Oracle Argus Safety Version 7. The fundamental idea behind the consortium is that customers take advantage of lower costs due to the sharing of set-up activities, validation documentation and deliverables. The Oracle Argus system would be released to the customer with a standard configuration which is shared among multiple end users.
The concept of sharing implementation activities guarantees at least a 20% reduction in costs for Consortium subscribers. The benefits to joining are:
- Access to experienced Project/Account Manager during set-up and production
- Get a standard configuration built on best standard practices and experience
- Have the PhV application hosted in a certified Data Center with backup/recovery processes in place
- Compliance and regulatory expertise and support during inspections
- Use of International Standards (GAMP5) and Internal QMS
- Multidisciplinary team covering all validation aspects (Business analysts, IT experts, CSV specialists)
Why is the Consortium an ideal solution for pharmacovigilance departments?
Step 1: Oracle Argus Safety Version 7 is an ideal solution for managing global workflow while providing case reports and instant safety data reports and analysis. It is an up-to-date pharmacovigilance system that meets all the requirements of computerized systems in the GVP environment. As an Oracle Business Processing Services (BPS) provider, ARITHMOS provides the Oracle Argus Safety license with payment based on cases entered in a defined time period with no annual maintenance fee.
Step 2: The Consortium initiative also covers compliance and Computer System Validation aspects of pharmacovigilance through a Quality by Design approach. As a member of the Consortium, a cross-functional team of validation experts are available to make sure the system is maintained properly through periodic review and change control.
Consortium ROI: Consortium membership guarantees cost reduction through the sharing of implementation activities and documentation. However, the real Return on Investment comes from access to validation experts, advice and feedback from other Consortium members and access to “My Oracle”, which is Oracle’s official web portal for the support of its applications – guaranteeing a smooth, compliant and risk free pharmacovigilance process.
The Consortium is a yearly initiative with limited subscriptions available. For more information on a pharmacovigilance system migration project and Consortium membership, contact ARITHMOS at firstname.lastname@example.org.