New in Ennov InSight 7.3.3: Common Functionality
This table shows new features and enhancements of Ennov InSight 7.3 functionality.
eCTD 4.0
To support eCTD 4.0, the following features are added:
| Affected Area | Update | Benefit |
| Data Administration |
The following updates have been made to Data Administration: — eCTD 4.0 Template Mapping in Assembly DTD/Schema Types. See Data Administration Tables Updated: Ennov InSight 7.3.3 |
To provide flexible configuration while updating submissions from eCTD 3.2 to eCTD 4.0, new attributes are added to Data Administration. |
IDMP
To capture additional data elements for European Medicine Agency (EMA) implementation of IDMP.
| Affected Area | Update | Benefit |
| Entities/Entity tabs |
To confirm to the latest IDMP specification, the following tab has been updated: — Attached Documents. See Entity Fields, Columns and Options Added: Ennov InSight 7.3.3 |
The ability to view/add countries associated with the selected medicinal product on the Attached Documents page. The ability to create attached documents in accordance with the latest European Medicine Agency (EMA) IDMP requirements. |
Ennov InSight RIM 7.3 Release Notes
Cumulative
New in Ennov InSight 7.3.3: Common Functionality
| Affected Area | Update | Benefit |
|
Data Administration |
To conform to the latest IDMP specification, the following changes have been made to Data Administration: — New fields added to Product Detail Set Maintenance > Manufacturer Values > Manufacturing Authorization Reference Number — New Data Carrier Identifier Source Values table added to Data Administration > Other — New Data Carrier Identifier Source value added to Registration Maintenance > Data Carrier Type — Medicinal Product Action/Submission Statues Values table moved from Registration Maintenance to Application Maintenance — Medicinal Product Name Part Type Values table moved from Registration Maintenance to Application Maintenance — Medicinal Product Type Values table moved from Registration Maintenance to Application Maintenance See Data Administration Tables Added: Ennov InSight 7.3.3, Data Administration Table Updated: Ennov InSight 7.3.3, Data Administration Table Removed:Ennov InSight 7.3.3 |
The ability to populate Data Administration values in accordance with the latest European Medicine Agency (EMA) IDMP requirements. |