Ennov InSight 7.3.3 Release Notes

Entity Fields, Columns and Options Added: Ennov InSight 7.3.3

The following tables describe fields and columns that were added in this release. These include the fields and column that were added to support IDMP data capture and eCTD 4.0 publishing standards.

Medicinal Product Action

Table 1. IDMP Data Visualization
Field/Column/Option Name Field Type Description Business Rules
N/A N/A The IDMP Data Visualization page now includes the validation messages from Job Requests. To conform to the latest IDMP specification released and to improve the user experience, the validation messages from Job Requests are also available from the IDMP Data Visualization page.
Table 2. Attached Documents
Field/Column/Option Name Field Type Description Business Rules
Attached Document Country Drop-down The Attached Documents page now includes the respective field. New Attached Document Field is displayed under the Attached Document Effective Date. Values for the new field are taken from the Application Maintenance > Countries Values DA List.

The new field can be populated on the Create Attached Document page and modified on the Edit Attached Document page.

Manufactured Item

Table 3. Reference Active Ingredient
Field/Column/Option Name Field Type Description Business Rules
Alternate IDMP Reference Active Ingredient Selection widget, drop-down The following pages are updated to include this field:
  • Create Reference Active Ingredient
  • Reference Active Ingredient Attributes
  • Modify Reference Active Ingredient Attributes
The Alternate IDMP Reference Active Ingredient field is hidden OTB and only available if unhidden using overrides.

This field can be configured as a substance selection widget with all active values from Data Administration > Substance Values, or as drop-down list with the values from the Component > Reference Active Ingredient.

Only one value can be selected for the Alternate IDMP Reference Active Ingredient field and it can not be updated.

Pharmaceutical Product

Table 4. Reference Active Ingredient
Field/Column/Option Name Field Type Description Business Rules
Alternate IDMP Reference Active Ingredient Selection widget, drop-down The following pages are updated to include this field:
  • Create Reference Active Ingredient
  • Reference Active Ingredient Attributes
  • Modify Reference Active Ingredient Attributes
The Alternate IDMP Reference Active Ingredient field is hidden OTB and only available if unhidden using overrides.

This field can be configured as a substance selection widget with all active values from Data Administration > Substance Values, or as drop-down list with the values from the Component > Reference Active Ingredient.

Only one value can be selected for the Alternate IDMP Reference Active Ingredient field and it can not be updated.

PDS Details

Table 5. Packaging Details
Field/Column/Option Name Field Type Description Business Rules
Device Quantity Unit of Measurement Drop-down The following pages now include the respective field:
  • PDS Packaging > Add Packaging
  • PDS Packaging > Edit Packaging
  • PDS Packaging > Package Detail Attributes
Values for the Device Quantity Unit of Measurement field are taken from the Other > Units of Measurement Values Data Administration list.

The Device Quantity Unit of Measurement field can not be populated if the Device Quantity Unit of Presentation field is already populated. Trying to populate the field in this case results in the You can set only one Device Quantity Unit type warning message.