Entity Fields, Columns and Options Updated: Ennov InSight 7.3

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 and eCTD 4.0 publishing standards.

Product Family


Field/Option Name	Field Type	Description	Business Rules
Active Ingredients	Selection widget	This field is updated with improved Substance Search selection widget.	Users have an ability to search for a value using a modern Selection Widget with a wider and more advanced search capabilities and configure columns display and the number of values per page.

Сomparator

Product Detail Set

Table 19: Substance


Field/Option Name	Field Type	Description	Business Rules
Substance Name	Selection widget	This field is updated with improved Substance Search selection widget on the Product Detail Set Attributes > Substances Properties > Add Substance and on the Product Detail Set Template Attributes > Substances Properties > Add Substance pages.	Users have an ability to search for a value using a modern Selection Widget with a wider and more advanced search capabilities and configure columns display and the number of values per page.

Table 20: Flu Strain


Field/Option Name	Field Type	Description	Business Rules
Reference Strain Name	Selection widget	This field is updated with improved Substance Search selection widget on the Product Detail Set Attributes > Active Ingredients > Active Ingredient Detail Attributes > Flu Strain Attributes > Add Reference Strain and on the Product Detail Set Template Attributes > Active Ingredients > Active Ingredient Detail Attributes > Flu Strain Attributes > Add Reference Strain pages.	Users have an ability to search for a value using a modern Selection Widget with a wider and more advanced search capabilities and configure columns display and the number of values per page.

Component

Table 21: Reference Active Ingredient


Field/Option Name	Field Type	Description	Business Rules
Reference Active Ingredient Name	Selection widget	This field is updated with improved Substance Search selection widget on the Component Attributes > Active Ingredients > Reference Active Ingredient > Create Reference Active Ingredient page.	Users have an ability to search for a value using a modern Selection Widget with a wider and more advanced search capabilities and configure columns display and the number of values per page.

Table 22: Manufactured Item


Field/Option Name	Field Type	Description	Business Rules
Substance Name	Selection widget	This field is updated with improved Substance Search selection widget on the Manufactured Item Attributes > Substances > Create Substance page.	Users have an ability to search for a value using a modern Selection Widget with a wider and more advanced search capabilities and configure columns display and the number of values per page.

Table 23: Reference Substances


Field/Option Name	Field Type	Description	Business Rules
Reference Substance Name	Selection widget	This field is updated with improved Substance Search selection widget on the Manufactured Item Attributes > Substances > Reference Substances > Create Reference Substance page.	Users have an ability to search for a value using a modern Selection Widget with a wider and more advanced search capabilities and configure columns display and the number of values per page.

Pharmaceutical Product

Table 24: Substances


Field/Option Name	Field Type	Description	Business Rules
Substance Name	Selection widget	This field is updated with improved w Substance Search selection widget on the Pharmaceutical Product Attributes > Substances > Create Substance page.	Users have an ability to search for a value using a modern Selection Widget with a wider and more advanced search capabilities and configure columns display and the number of values per page.

Table 25: Reference Substances


Field/Option Name	Field Type	Description	Business Rules
Reference Substance Name	Selection widget	This field is updated with improved Substance Search selection widget on the Pharmaceutical Product Attributes > Substances > Reference Substances > Create Reference Substance page.	Users have an ability to search for a value using a modern Selection Widget with a wider and more advanced search capabilities and configure columns display and the number of values per page.

Attached Document

Table 26: Attached Document


Field/Column/ Option Name	Field Type	Description	Business Rules
N/A	N/A	The Attached Document entity is now available for all the Application Procedure Types.	To conform to the latest IDMP specification, the entity has been updated.

Table 27: Attached Document Attributes


Field/ Column/ Option Name	Field Type	Description	Business Rules
Content Type	Dropdown list	On the Attached Document Attributes page, these fields are renamed to:	To conform to the latest IDMP specification released, the
Effective Date	Date	— Attached Document Type — Attached Document Effective Date	existing attributes have been updated for the entity.
Language	Dropdown list	— Attached Document Language

Assembly: eCTD 4.0

Table 28: Assembly Attributes


Field/Column/ Option Name	Field Type	Description	Business Rules
Create an Assembly > Existing Template, Assembly or View	Option	The Create an Assembly > Existing Template, Assembly or View option is updated on the Create Assembly page to track the creation process of an assembly from another assembly in Job Requests if the number of folder child nodes exceeds the value set in the configuration.	Users can track the creation process of an assembly from another assembly in Job Requests. When creating an assembly from another assembly if the number of folder child nodes exceeds the value set in a configuration, the message is displayed asking to check the Job Requests for a status.

Table 29: Folder Attributes


Field/ Column/ Option Name	Field Type	Description	Business Rules
Duplicate	Option	The Duplicate option is updated on the Folder Attributes page to track the duplicate folder process in Job Requests if the number of folder child nodes exceeds the value set in the configuration.	Users can track the duplicate folder process in Job Requests. After clicking the Duplicate on the folder, if the number of folder child nodes exceeds the limit, the message is displayed asking to check the Job Requests for a status.

Assembly

Table 30: Document Attributes


Field/ Column/ Option Name	Field Type	Description	Business Rules
View File	Option	The View File option is updated on the Document Attributes page to track the download process in Job Requests for the files that are equal or bigger than the file size value set in the configuration.	Users can track the download process in Job Requests. After clicking the View File if the file size exceeds the limit, the message is displayed asking to check the Job Requests for a status.

Product Detail Set

Table 31: Package Set


Field/Column/ Option Name	Field Type	Description	Business Rules
Package Type	Dropdown list	On the Package Set > Packaging > Package Detail Attributes page, these fields are renamed to:	To conform to the latest IDMP specification released, the existing
Package Item Container Quantity	Text field	— Package Item Type — Package Item Quantity — Package Item Material	attributes have been updated for the entity.
Package Material	Multiselect	— Package Item Alternate Material — Package Item Component(s)
Package Alternate Material	Multiselect	— Package Item - MI Quantity — Package Item - MI Quantity Unit
Package Components	Select
Packaging MI Quantity	Text field
Packaging MI Quantity Unit	Dropdown list

Table 32: Indication/ Intended Use


Field/ Column/ Option Name	Field Type	Description	Business Rules
Countries	Multiselect	This field is updated to optional from required on the Add Indication/Intended Use window.	Multiple sub-nodes can be created for the same Indication but Country values will not be available for selection. Country values are available only when you create a new sub-node for another Indication. If all values for the Country field are selected, it will not be possible to create a new sub-node unless you modify or delete the existing one.

Wizards

Table 33: Global Project Plan


Field/Option Name	Field Type	Description	Business Rules
— Active Ingredient — Substance	Selection widget	These fields are updated with improved Substance Search selection widget for the following pages: — Global Project Plan > Update Product Detail Sets > Active Ingredient > Input Query Filter Criteria — Global Project Plan > Update Product Detail Sets > Substance > Input Query Filter Criteria	Users have an ability to search for a value using a modern Selection Widget with a wider and more advanced search capabilities and configure columns display and the number of values per page.