New in Ennov InSight 7.3: Common Functionality
This table shows new features and enhancements of Ennov InSight 7.3 functionality.
eCTD 4.0
To maintain a new eCTD 4.0 standard.
| Affected Area | Update | Benefit |
| Entities/Entity tabs |
Changes for eCTD 4.0 now include: — Entity updates:
Application > Application Attributes and Registrations > Application > Sender-defined Keywords.
|
The ability to separate different submission standards and use the functionality defined by the selected standard. |
| Affected Area | Update | Benefit |
| Data Administration |
To conform to eCTD 4.0 requirements, the following updates have been made to Data Administration: — New CV Profile Values table in Data Administration > eCTD 4.0 Submission Maintenance. — New Sender-defined Keyword Values table in Data Administration > eCTD 4.0 Submission Maintenance. — Updated Applicant Contact Type Values table in Data Administration > Submission Maintenance — Updated Applicant Contact Values table in Data Administration > Submission Maintenance |
To conform to eCTD 4.0 requirements, new attributes are added to Data Administration. |
IDMP To maintain IDMP updates:
| Affected Area | Update | Benefit |
| Entities/Entity tabs |
IDMP updates include: — Attached Document updates. See Entity Fields and Columns Added: Ennov InSight 7.3, Entity Fields and Columns Updated: Ennov InSight 7.3 — Manufactured Item updates. See: Entity Fields and Columns Added: Ennov InSight 7.3 |
To conform to the latest IDMP specification, new attributes are added to the entities and some existing attributes are updated. |
| Affected Area | Update | Benefit |
| Data Administration |
IDMP updates include: — New Data Administration Tables. See: Data Administration Tables Added: Ennov InSight 7.3:
Values table in Application Maintenance.
■ eCTD EU Context of Use ■ Medical Device Classification ■ Medical Device Legislative Category ■ Medicinal Product Type ■ Medicine Profile ■ Regulating Authority Submission Unit Type ■ Source of Information — Updated Data Administration Tables. See: Data Administration Tables Updated: Ennov InSight 7.3:
Device -Type of Combination Values
— Removed Data Administration Tables. See: Data Administration Tables Removed: Ennov InSight 7.3 |
To conform to the latest IDMP specification, new attributes are added to the Data Administration. |
| ©Ennov 2024 |
• Application Maintenance > Product Information Document7 Enno Type Values |
v InSight RIM 7.3 Release Notes Cumulative |
| Ennov | Ennov InSight 7.3 Release Notes |
| Affected Area | Update | Benefit |
| Security Administration | Updated Security Administration Tables. See: Security Administration Tables Updated: Ennov InSight 7.3. | To support user's business flow of usage xEVMPD and IDMP. |
Entity Updates To conform the application updates to simplify data creation:
| Affected Area | Update | Benefit |
| Entities/Entity tabs |
Entity updates include the improved Substance Search selection widget implemented. See: Entity Fields, Columns and Options Updated: Ennov InSight 7.3 — Product Family Attributes — Comparator Attributes — Product Detail Set Attributes > Substances Properties > Add Substance — Product Detail Set Template Attributes > Substances Properties > Add Substance — Product Detail Set Attributes > Active Ingredients > Active Ingredient Detail Attributes > Flu Strain Attributes > Add Reference Strain — Product Detail Set Template Attributes > Active Ingredients > Active Ingredient Detail Attributes > Flu Strain Attributes > Add Reference Strain — Component Attributes > Active Ingredients > Reference Active Ingredient > Create Reference Active Ingredient — Сomponent Attributes > Manufactured Items > Substances > Create Substance — Сomponent Attributes > Manufactured Items > Substances > Reference Substances > Create Reference Substance — Pharmaceutical Product Attributes > Substances > Create Substance — Pharmaceutical Product Attributes > Substances > Reference Substances > Create Reference Substance |
Improved selection widget capabilities with the updated data model enables simplified data creation. |
| Affected Area | Update | Benefit |
| Data Administration |
Updates include the Substance Search selection widget implemented. See: Data Administration Tables Updated: Ennov InSight 7.3 — Manufacturer Values > Global Product Details — Other > Certificate Master File Values |
Improved selection widget capabilities with the updated data model enables simplified data creation. |
| Affected Area | Update | Benefit |
|
Create Application Wizard |
The Create Application wizard is updated with the new fields when creating a sequence. See: Entity Fields and Columns Added: Ennov InSight 7.3 | To maintain a new controlled vocabularies for quick and easy eCTD 4.0 specification updates in future, the sequence and other related submission options updates are introduced. |
Product Detail Set
| Affected Area | Update | Benefit |
| Entities/Entity tabs |
IDMP updates include: — Entity updates: • Product Details Set. See: Entity Fields and Columns Added: Ennov InSight 7.3, Entity Fields and Columns Updated: Ennov InSight 7.3, Entity Fields and Columns Deleted: Ennov InSight 7.3, Ennov InSight 7.3 Registrations > PDS > Product Details in PDS > Intended Effect / Comorbidity sub-node |
The ability to track intended effects/ comorbidities for the specific Indication and countries that are listed on the Indication/ Intended Use Attributes page. |