Product Information Management
ProductExpert™ addresses planning and management of medicinal product data submissions throughout the submission lifecycle, post-submission, and post-approval according to the IDMP target operating model.
Benefits
Standardized Processes
Standardize product registration information, content and other meta-information
Single Source of truth
Establish a single source of truth for medicinal product data in an organization
Decision Enablement
Enable decision-making about global product portfolios
Maintain Data & Overview
Maintain medicinal product information and data sets
Process Adherence
Adhere to agency requirements on timelines and content
Compliance
Create compliant data submission outputs without any technical knowledge
Quality
Increase consistency and data quality through data inputs validation and controlled terminology
Automation
Automate the creation and update of medicinal products as part of the overall RIM process
ProductExpert™ Features
- Tracking medicinal product registrations, content and other meta-information
- IDMP data granularity and support for the target operating model
- Support for internally and externally defined controlled vocabularies with RMS interoperability
- Master data life cycle management supporting product information reuse
- Integration with data extraction tools to support data enrichment and quality control
- Rich data and business rule validations
- Advanced automation of processes as part of the end-to-end RIM
- Embedded XEVPRM creation and EMA gateway communication including acknowledgement processing
- Embedded FHIR creation and EMA PMS data submission including status tracking
- History and record tracking of medicinal product information
- Archiving of XEVPRM and FHIR messages and acknowledgments
- Interactive dashboards for actionable product information overview
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