POLARIS
Polaris - Driving speed and accuracy into product submission process
Polaris benefits Life Science companies in a global market with increasing regulatory challenges
European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP). These standards specify the use of standardized definitions for the identification and description of medicinal products for human use. This facilitates the reliable exchange of medicinal product information in a robust and consistent manner, by providing a common product ’language’ for stakeholders to use in their interactions. Following the implementation of the ISO IDMP standards, the agency will replace its data-submission format in line with the ISO IDMP standards, terminology and formats.
Judit Virgula
Polaris Product Owner
To prepare product information submission, companies must gather vast amount of data across their enterprises (regulatory, R&D, supply chain,..). Gramont Polaris is the SAP Cloud Application used to consolidate structured and unstructured data to prepare electronic submission of regulatory dossier for marketing authorization. It enables the integration, aggregation and standardization of those data as well as their conversion into ISO IDMP standards, terminology and formats. It offers a flexible architecture that helps companies meet additional regulations requirements as they emerge.
What is Polaris?
Polaris is the SAP Cloud Application used to consolidate structured and unstructured data from multiple existing sources (ERP, MDG, PLM, Clinical Trial, Excel,…) to prepare electronic submission of regulatory dossier for marketing authorization.
It includes
- Management of product information (Medicinal products, Devices, FMCG products…)
- Preparation of regulatory specific content, submission and tracking of market authorization
- Management of structured and unstructured data
- Management of controlled vocabularies
- Planning, tracking, integration of changes
- Embedded data quality and data consistency checks
- A flexible framework accommodating current and future data-exchange procedures globally
It is an integrated extension of the SAP ECC and S4 products and is SAP’s standard way to manage this part of the product data submission/registration business process.
Features of GRAMONT Polaris
1) Product information Aggregation & Publication platform
- Enable collaboration and Leverage enterprise master data for both regulatory and internal business purposes via Integration with PLM, ERP, MDG,… and embedded RIM system
- Harmonize data from different source systems, SAP and non-SAP
- Integration of controlled vocabularies
- Integrated and automated data exchange with Regulatory agencies
2) Transparency supporting data quality and reporting
- Simple, intuitive UI gives user consolidated data to identify and correct inconsistencies in the most optimized way
- Integrated management of product versions and extensions over time, providing data owners with data changes identification and automatic alert in case of significant change impact
- Advanced reporting capabilities and analytics
3) Built-in Extensibility
- Ensure extensibility through a flexible framework that can accommodate current and future data-exchange procedures globally
- Integrated management of product versions and extensions over time, providing data owners with data changes identification and automatic alert in case of significant change impact
- Adaptable framework to life sciences and FMCG for regulatory submission and/or product information for e-commerce publication
Maintenance Events
Please get in contact for informations on upcoming Maintenance Events
