PLM Vivo PRO for BioPharma Product Registrations
With global product registration a complex and constantly evolving process, product registration management is becoming increasingly difficult in the biopharma industry, with the process ranging anywhere from days to years. In order to avoid serious risks, costly delays or even fines, companies must be able to achieve and maintain regulatory compliance as quickly and efficiently as possible.
With PLM Vivo PRO for Product Registrations, biopharma companies are able to capture, access and manage accurate product lifecycle data and product registration records to meet strict regulations. PLM Vivo PRO for product registrations is an enhancement of the standard PLM Vivo for BioPharma accelerator package, providing a more comprehensive solution for companies to manage their product registration processes.
PLM Vivo PRO for Product Registrations is built on Oracle’s Agile Product Governance & Compliance application, which enables organizations to manage product, substance, and material compliance against standards and regulatory requirements.
Pre-configured based on best-in-class product registration practices, this solution includes:
- An extended data model supporting international product registrations
- Templates for commonly required documents
- Pre-configured international product registration process integrated with product release process
- Product registration templates for international submissions
- Pre-defined workows based on leading submission practices
To learn how PLM Vivo PRO for Product Registrations can help significantly reduce the complexity, time and effort of your company’s product registration process, download the brochure or contact Horst Groesser.