ReALM® Registrations module allows for the management of product registration information for various markets, both new and ongoing lifecycle activities, specifically around any pre-registration and site registration activities. The module comes with web services, such as document management and submission publishing, that allow integration to enterprise and cloud applications.
Features:
- Compatible with DIA RIM Reference Model and IDMP-ready product master definition and inclusion of controlled vocabularies for most data elements.
- Ability to manage product registration information and approval letters and approved labels.
- Ability to search for various characteristics of product registrations.
- Ability to manage life cycle activities including variations, amendments, etc.
- Dashboard of product registrations by country, product and status, etc.
- Integration with upstream document management and submission publishing applications.
- Integrate with ReALM® Interactions module to track health authority interactions (correspondences, requests, and commitments) by product and country.
Benefits:
- Distribute ownership of product registrations and approvals at the country, regional, and headquarters levels.
- Provide visibility to updated product life cycle information and approval status.
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