The registration and product portofolio life cycle management in a global market place is one of the most important tasks of the regulatory affairs department. To perform this job in an accurate and efficient manner for several products and variations in different countries accurate information has to be provided on the fly.
EXTEDO’s DRAmanager is a configurable all-in-one product portfolio management and registration tracking system. It provides an overview of managing product related information and the numerious activities and ressources associated with national and global submissions procedures (e.g. EU CP, MRP & DCP, NP, FDA NDA) and submission types (initial marketing authorisation, variation, amendment, information after questions, prolongation, PSUR, etc.)
Important features include:
• Business excellence and product control
• Intuitive and ergonomic user interface
• Advanced features for task management, reporting and information retrieval
• Compliance with 21 CFR Part 11
• Extensive Reporting Capabilities
• Integrated Workflow Engine and Task View Management of medicinal product and submission data from a global perspective:
• Powerful and configurable data management capabilities.
• Standard management reports as well as configurable reporting functionality
• Imbedded workflow engine for the automated management of registration tasks
• Export and Import functionalities for data based on overall accepted regulatory data exchange formats (e.g. EVMPD)
• Configurable dashboard overview to provide managers information on the right level of abstraction.
DRAmanager provides globally distributed workgroups to simultaneously access and maintain product data. DRAmanager can be easily integrated into document management systems such as:
• EMC Documentum Content Manager
• FCG First Doc, FCG First Point
• IBM Score
• Microsoft Sharepoint
• OpenText Livelink
• QUMAS DocCompliance
• and others to share data sources or link to certain content objects.