Ennov InSight 7.3.3 Release Notes

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 1. 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 2. 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 3. 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.

Data Administration: Assembly

Table 4. 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 5. 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.