Data Administration Sections Updated: Ennov InSight 7.3
Data Administration tables, sections, options, widgets, filters or fields updated in Ennov InSight 7.3 release.
Data Administration Section: Other
Table 45: Attached Document Content Type Values
| Entity Affected | Column/Field Name | Value List Description |
|
Attached Document Content Type Values |
— Term ID — Term Name — Short Name — Mapping Source — Source Term ID — xEVMPD Code — ISO Code |
To capture and maintain correct SPOR controlled vocabulary lists for submitting data to EMA, the Attached Document Content Type Values is updated to allow RMS data association only from following SPOR Master Lists: — Product Information Document Type — eCTD EU Context of Use — Regulating Authority Submission Unit Type |
Table 46: Certificate Master File Values
| Entity Affected | Column/Field Name | Value List Description |
| Substance | Substance Reference | This field is updated with improved Substance Search selection widget. |
Data Administration Section: Product Detail Set Maintenance
Table 47: Component Type Values
| Entity Affected | Column/Field Name | Value List Description |
| N/A |
— RMS Term ID — RMS Modified On — RMS Status |
To conform to IDMP requirements to capture additional RMS data, the Сomponent Type Values grid now includes the respective columns. The RMS tab is updated to allow data association from SPOR Master Lists > Container Category . |
| Entity Affected | Column/Field Name | Value List Description |
| Substance | Substance Name |
This field is updated with improved Substance Search selection widget on the Manufacturer > Global Product Details > Global Detail Sets page (Detail Type > Substance). |
Table 48: Device -Type of Combination Values
| Entity Affected | Column/Field Name | Value List Description |
| N/A |
— RMS Term ID — RMS Modified On — RMS Status |
To conform to IDMP requirements to capture additional RMS data, the Device -Type of Combination Values grid now includes the respective columns. The RMS tab on the Device -Type of Combination Values page is enabled and updated to allow data association from SPOR Master Lists > Medical Device Legislative Category. |
Table 49: Intended Effect Values
| Entity Affected | Column/Field Name | Value List Description |
| N/A |
— Term ID — Term Name — Description — Last User Updated — Last Changed Date — Active Flag — RMS Term ID — RMS Modified On — RMS Status |
The Intended Effect Values attributes page is updated with RMS tab, including the columns to associate and display the data from SPOR Master Lists > Medicine Profile . |
Table 50: Manufacturer Values
Table 51: Substance Type Values
| Entity Affected | Column/Field Name | Value List Description |
| Substance |
— Term ID — Term Name — Description — Last User Updated — Last Changed Date — Active — RMS Term ID — RMS Modified On — RMS Status |
The Substance Type Values page is updated with RMS tab, including the columns to associate and display the data from SPOR Master Lists > Ingredient Role. |
Data Administration Section: Registration Maintenance
Table 52: Data Carrier Type Values
| Entity Affected | Column/Field Name | Value List Description |
| N/A |
— Term ID — Term Name — Description — Last User Updated — Last Changed Date — Active Flag — RMS Term ID — RMS Modified On — RMS Status |
To conform to IDMP requirements to capture additional RMS data, the Data Carrier Type Values attributes page is updated with RMS tab, including the columns to associate and display the data from SPOR Master Lists > Source of Information. |
Table 53: Registration Status Values
| Entity Affected | Column/Field Name | Value List Description |
| Registration Status Values |
— Term ID — Term Name — Description — Last User Updated — Last Changed Date — Active Flag — RMS Term ID — RMS Modified On — RMS Status |
To conform to IDMP requirements to capture additional RMS data, the Registration Status Values attributes page is updated to associate and display the data from SPOR Master List > Regulatory Entitlement Status. |
Data Administration Section: Submission Maintenance
Table 54: Applicant Contact Values
| Entity Affected |
Field/Column Name |
Value List Description |
| Applicant Contact |
— UUID — Prefix — First Name — Middle Name — Last Name — Suffix — Initials — Delimiter — Represented Company Name |
To support 4.0 and 3.2 specification updates, you can now create an applicant contact with specific attributes. The Applicant Contact Values table is now updated with these fields. |