Ennov InSight 7.3.3 Release Notes

Entity Fields, Columns and Options Updated: Ennov InSight 7.3.3

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

Applications

Field/Column/Option Name Field Type Description Business Rules
Associated Products Selection widget For the following pages, this field is updated with improved Product Search selection widget:
  • Applications > Create Application
  • Application Attributes > Associate/Dissociate Products
The improved Product Search selection widget allows to filter search results using the following criteria:
  • All Products Family
  • Family Code
  • Family Name
  • Family Type
  • Product Code
  • Product Name
  • Product Status

The Family Name filter remains blank if an application is associated with multiple product families.

By default, only 20 products are displayed per page. However, this number can be increased via overrides. To configure overrides, please contact your Business Support Representative.

Events

Field/Column/Option Name Field Type Description Business Rules
Products Selection widget The improved Product Search selection widget is added to the following pages:
  • Events > Create Application
  • Event Attributes > Associate/Dissociate Products
With the improved Product Search selection widget, you can filter search results using the following criteria:
  • All Products Family
  • Family Code
  • Family Name
  • Family Type
  • Product Code
  • Product Name
  • Product Status

The Family Name filter remains blank if an application is associated with multiple product families.

By default, only 20 products are displayed per page. However, this number can be increased via overrides. To configure overrides, please contact your Business Support Representative.

Product Registration

Field/Column/Option Name Field Type Description Business Rules
Products Selection widget The improved Product Search selection widget is added to the following pages:
  • Application Attributes > Create Registration
  • Registration Attributes > Associate/Dissociate Products
With the improved Product Search selection widget, you can filter search results using the following criteria:
  • All Products Family
  • Family Code
  • Family Name
  • Family Type
  • Product Code
  • Product Name
  • Product Status

The Family Name filter remains blank if an application is associated with multiple product families.

By default, only 20 products are displayed per page. However, this number can be increased via overrides. To configure overrides, please contact your Business Support Representative.

Registrations

Table 1. Registration-Package Set
Field/Column/Option Name Field Type Description Business Rules
PDS Package Status Date Read-only text The respective field is renamed to PDS Package Set Status Date on the following pages:
  • Modify Registration Package Set Association
  • Registration-Package Set Attributes
  • Entity Audit Trail
To conform to the latest standards set by International Organization for Standardization (ISO) and also improve the user experience, the field name is also renamed on the Registration-Package Set tab.
Table 2. Package Descriptions
Field/Column/Option Name Field Type Description Business Rules
Package Description Box The respective field is renamed to PMP Package Description on the following pages:
  • Create Package Description page
  • Modify Package Description
  • Package Set-Package Description Attributes
  • Entity Audit Trail
Also, the renamed field is now displayed in the Search Results table when using the Registration Package Set > Entity History Query option. 		To conform to the latest standards set by International Organization for Standardization (ISO) and also improve the user experience, the existing fields have also been renamed on the Package Descriptions tab.
Language Select The respective field is renamed to PMP Package Description Language on the following pages:
  • Create Package Description
  • Modify Package Description
  • Package Set-Package Description Attributes
  • Entity Audit Trail
Also, the renamed field is now displayed in the Search Results table when using the Registration Package Set > Entity History Query option. 		To conform to the latest standards set by International Organization for Standardization (ISO) and also improve the user experience, the existing fields have also been renamed on the Package Descriptions tab.
Table 3. PDS-Manufacturer Details
Field/Column/Option Name Field Type Description Business Rules
  • Manufacturer Operation Start Date
  • Manufacturer Operation Stop Date
Date The fields are renamed to the Manufacturing Operation Start Date and Manufacturing Operation End Date respectively on the following pages:
  • Add Manufacturer
  • Edit Manufacturer
  • Manufacturer Detail Attributes
  • Entity Audit Trail
To conform to the latest standards set by International Organization for Standardization (ISO) and also improve the user experience, the existing fields have been updated on the PDS-Manufacturer Details page.

Pharmaceutical Product

Table 4. Active Ingredient
Field/Column/Option Name Field Type Description Business Rules
Active Ingredient Name Drop-down On the Create Active Ingredient page, the field allows users to select the same substance value multiple times even if it was previously used to create Active Ingredient. This functionality is only available if the Alternate IDMP Active Ingredient Name field is configured via overrides and contains a unique value.

Manufactured Items

Field/Column/Option Name Filed Type Description Business Rules
Manufactured Item Characteristics/Description Text On the following pages, the field length is increased to allow entering/displaying of up to 4000 characters when using single-byte character sets (one byte per character):
  • Create Manufactured Item
  • Modify Manufactured Item
  • Manufactured Item Attributes
  • Entity Audit Trail
To conform to the latest standards set by International Organization for Standardization (ISO) and also improve the user experience, the maximum field length is increased. New rule is only applicable for single-byte character sets.
Active Ingredient Name Drop-down On the Create Active Ingredient page, the field allows to select the same substance value multiple times even if it was previously used to create Active Ingredient. This functionality is only available if the Alternate IDMP Active Ingredient Name field is configured via overrides and contains a unique value.

PDS Details

Table 5. PDS Packaging Detail
Field/Option/Column Name Field Type Description Business Rules
Device Quantity Unit Drop-down The respective field is now renamed to the Device Quantity Unit of Presentation.

To conform to the latest standards set by International Organization for Standardization (ISO) and also improve the user experience, the Device Quantity Unit field is renamed. Also, the values for the Device Quantity Unit field will not be populated if the Device Quantity Unit of Measurement 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 displayed.

Wizards

Table 6. Create Application
Field/Column/Option Name Field Type Description Business Rules
Associated Products Selection widget For the following pages, this field is updated with improved Product Search selection widget:
  • Events > Create Event
  • Event Attributes > Associate/Dissociate Products
New Product Search selection widget allows to filter search results using the following criteria:
  • All Products Family
  • Family Code
  • Family Name
  • Family Type
  • Product Code
  • Product Name
  • Product Status

The Family Name filter remains blank if an application is associated with several product families.

By default, only 20 products are displayed per page. However, this number can be increased via overrides.

Table 7. Create eCTD
Field/Column/Option Name Field Type Description Business Rules
Copy TOCs and Special Sheets Check box This field is not available in the Create eCTD wizard, when the submissions are created from the sequence which has the eCTD 4.0 value selected in the Sequence Standard Type. To expand the eCTD 4.0 functionality and maintain the functionality of the existing submission elements, the wizards and features are updated accordingly.
Template Selection Drop-down list This field is updated to load the corresponding eCTD 3.2 or eCTD 4.0 templates based on the region, values selected in the Sequence Standard Type and defined configuration.