Ennov InSight 7.3.3 Release Notes

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.
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.