Data Administration Tables Updated: Ennov InSight 7.3.3
Data Administration tables were updated for Ennov InSight 7.3.3 release.
Data Administration Section: Application Maintenance
Table 81: Medicinal Product Action/Submission Status Values
| Entity Affected | Column/Field Name | Value List Description |
|
Medicinal Product Action / Submission Status Values |
— Status Name — Last User Updated — Last Changed Date — Active Flag |
To conform to the latest IDMP requirements, the Application Maintenance DA List is updated to include the Medicinal Product Action/Submission Status Values table with respective fields/columns. Values for the Status Name field can now only be populated via Application Maintenance and not Registration Maintenance. |
Table 82: Medicinal Product Name Part Type Values
| Entity Affected | Column/Field Name | Value List Description |
|
Medicinal Product Name Part Type Values |
— Medicinal Product Name Part Type Name — RMS Term ID — RMS Modified On — RMS Status — Last User Updated — Last Changed Date |
To conform to the latest IDMP requirements, the Application Maintenance DA List is updated to include the Medicinal Product Name Part Type Values table with respective fields/columns. Values for the Medicinal Product Name Part Type Name field can now only be populated via Application Maintenance and not Registration Maintenance. |
Table 83: Medicinal Product Type Values
|
Entity Affected |
Column/Field Name | Value List Description |
|
Medicinal Product Type Values |
— Medicinal Product Type Name — Medicinal Product Type Code — RMS Term ID — RMS Modified On — RMS Status — Last User Updated — Last Changed Date — Active Flag |
To conform to the latest IDMP requirements, the Application Maintenance Data Administration List is updated to include the Medicinal Product Type Values table with respective fields/columns. Values for the fields Medicinal Product Type Name and Medicinal Product Type Code can now only be populated only via Application Maintenance and not Registration Maintenance. |
Ennov InSight RIM 7.3 Release Notes
Cumulative Data Administration Tables Updated:
Data Administration: Assembly
Table 84: Assembly DTD/Schema Types
| Entity Affected | Field Name | Value List Description |
| Assembly |
eCTD 4.0 Template Mapping |
To determine fields and settings transition while migrating to eCTD 4.0, the Assembly DTD/Schema Types table now includes this field. |
Data Administration Section: Product Detail Set Maintenance
Table 85: Manufacturer Values
| Entity Affected |
Field/Column Name |
Value List Description |
| Manufacturer |
— Function Types — Substances — Status Type — Status Date |
To conform to IDMP requirements, the Manufacturing Authorization Reference Number table now includes these these fields. |