Entity Fields and Columns Updated: Ennov InSight 7.1

The following tables describe fields that were modified in this release.

Product Family

Field/Option Name Field Type Description Business Rules
Product Family Indications/Intended Use Multi-select, read-only text (populated automatically) This field is renamed to Product Family Indication on the Product Family Attributes page. For Veterinary Product Family Type, this field is still Product Family Indications/Intended Use. The Assigned Indications box of the Product Family Indication field display values from the Indications field on the Indications/Intended Use PDS Attributes page.

Product

Field/Option Name Field Type Description Business Rules
Product Dosage Form Selection widget This field is renamed to Product Dose Form and updated with Dose Form Search selection widget. N/A

Pharmaceutical Product

Field/Option Name Field Type Description Business Rules
  • Product Quantity Value
  • Product Quantity Unit
  • Product Characteristics
Read-only text (populated automatically) These fields are hidden by default on the Pharmaceutical Product Attributes page. N/A
Administrable Dosage Form Selection widget This field is renamed to Administrable Dose Form and updated with Dose Form Search selection widget on the Pharmaceutical Product Attributes page. N/A
  • Pharmaceutical Product Name
  • Administrable Dose Form
  • Unit of Presentation
  • Pharmaceutical Product Description
  • Route of Administration
Read-only text (populated automatically) The Pharmaceutical Products tab now includes these columns. N/A

Component

Field/Option Name Field Type Description Business Rules
Active Ingredients and Reference Active Ingredients N/A The Active Ingredients and Reference Active Ingredients work logic is changed. These attributes are added one by one, not in bulk now. More than one Reference Active Ingredient can be added to Active Ingredient now. N/A
Component Form Selection widget This field is updated with Dose Form Search selection widget. N/A

Application

Field/Option Name Field Type Description Business Rules
Legal Status Drop-down list This field is renamed to Legal Status of Supply on the Application Attributes page. N/A

Registration

Field/Option Name Field Type Description Business Rules
EU Presentation Number Text field This field is renamed to Package Set License Code on the Registration- Package Sets > Associate Package Set page. N/A
Package Set Name Drop-down list This field is updated to select a PDS Package Set with a status of Pending Add and associate it to Registration Package Set entity while updating existing Registration. N/A

Active Ingredients and Reference Active Ingredients

Field/Option Name Field Type Description Business Rules
Active Ingredients/Reference Active Ingredients Read-only text (populated automatically) The Active Ingredients and Reference Active Ingredients tabs now include these columns for:
  • Component Attributes
  • Pharmaceutical Product Attributes
  • Pharmaceutical Product Substance
  • Pharmaceutical Product Reference Substance
  • Manufactured Item
  • Manufactured Item Substance
  • Manufactured Item Reference Substance
N/A

Product Detail Sets

Field/Option Name Field Type Description Business Rules
Indications/Intended Use Multi-select This field is renamed to Indications on the Indication/Intended Use (Add/Modify/Delete/View) pages. N/A
Indications/Intended Use Read-only text (populated automatically) This field is renamed to Indication on the Indication/Intended Use Detail Attributes Add/Modify/Delete/View) pages. N/A
Shelf Life Type Drop-down list The field value is modified to display details for the Shelf life(s)/storage condition(s) grouping node only. The options for this field are displayed from the Shelf Life Type Data Administration table. This field does not indicate the details for Shelf life(s)/storage condition(s) After Opening and Shelf life(s)/storage condition(s) After Reconstitution grouping nodes.
Shelf Life Grouping Drop-down list This field is renamed to Shelf Life Type on the Shelf Life/Storage Condition(s) (Add/Edit/View) pages. N/A
Concentration Measure Type Drop-down list This field type is updated to Read-only text (populated automatically) on the Product Detail Set > Add/Edit Active Ingredient pages. You can modify only the PDS attributes. You cannot modify the values populating from the Product Component Active Ingredient.
Low Amount Numerator Value Text field This field type is updated to Read-only text (populated automatically) on the Product Detail Set > Add/Edit Active Ingredient pages. You can modify only the PDS attributes. You cannot modify the values populating from the Product Component Active Ingredient.
Low Amount Numerator Prefix Drop-down list This field type is updated to Read-only text (populated automatically) on the Product Detail Set > Add/Edit Active Ingredient pages. You can modify only the PDS attributes. You cannot modify the values populating from the Product Component Active Ingredient.
Low Amount Numerator Unit Drop-down list This field type is updated to Read-only text (populated automatically) on the Product Detail Set > Add/Edit Active Ingredient pages. You can modify only the PDS attributes. You cannot modify the values populating from the Product Component Active Ingredient.
Low Amount Denominator Value Text fiedl This field type is updated to Read-only text (populated automatically) on the Product Detail Set > Add/Edit Active Ingredient pages. You can modify only the PDS attributes. You cannot modify the values populating from the Product Component Active Ingredient.
Low Amount Denominator Prefix Drop-down list This field type is updated to Read-only text (populated automatically) on the Product Detail Set > Add/Edit Active Ingredient pages. You can modify only the PDS attributes. You cannot modify the values populating from the Product Component Active Ingredient.
Low Amount Denominator Unit Drop-down list This field type is updated to Read-only text (populated automatically) on the Product Detail Set > Add/Edit Active Ingredient pages. You can modify only the PDS attributes. You cannot modify the values populating from the Product Component Active Ingredient.
High Amount Numerator Value Text field This field type is updated to Read-only text (populated automatically) on the Product Detail Set > Add/Edit Active Ingredient pages. You can modify only the PDS attributes. You cannot modify the values populating from the Product Component Active Ingredient.
High Amount Numerator Prefix Drop-down list This field type is updated to Read-only text (populated automatically) on the Product Detail Set > Add/Edit Active Ingredient pages. You can modify only the PDS attributes. You cannot modify the values populating from the Product Component Active Ingredient.
High Amount Numerator Unit Drop-down list This field type is updated to Read-only text (populated automatically) on the Product Detail Set > Add/Edit Active Ingredient pages. You can modify only the PDS attributes. You cannot modify the values populating from the Product Component Active Ingredient.
High Amount Denominator Value Text field This field type is updated to Read-only text (populated automatically) on the Product Detail Set > Add/Edit Active Ingredient pages. You can modify only the PDS attributes. You cannot modify the values populating from the Product Component Active Ingredient.
High Amount Denominator Prefix Drop-down list This field type is updated to Read-only text (populated automatically) on the Product Detail Set > Add/Edit Active Ingredient pages. You can modify only the PDS attributes. You cannot modify the values populating from the Product Component Active Ingredient.
High Amount Denominator Unit Drop-down list This field type is updated to Read-only text (populated automatically) on the Product Detail Set > Add/Edit Active Ingredient pages. You can modify only the PDS attributes. You cannot modify the values populating from the Product Component Active Ingredient.
Measurement Point Text field This field type is updated to Read-only text (populated automatically) on the Product Detail Set > Add/Edit Active Ingredient pages. You can modify only the PDS attributes. You cannot modify the values populating from the Product Component Active Ingredient.
Container Material Multi-select editable This field is renamed to Package Material on the Package Detail (Add/Edit) pages. N/A
Container Alternate Material Multi-select editable This field is renamed to Package Alternate Material on the Package Detail (Add/Edit) pages. N/A

Full Product Presentations

Field/Option Name Field Type Description Business Rules
Authorized Pharmaceutical Form Selection widget This field is updated with Dose Form Search selection widget. N/A

Wizards

Table 1. Create Application Wizard
Field Name Field Type Description Business Rules
Legal Status Drop-down list This field is renamed to Legal Status of Supply on the Enter values for a new application > Create Application page. N/A
Table 2. Update Applications Wizard
Field Name Field Type Description Business Rules
Legal Status Multi-select This field is renamed to Legal Status of Supply on the Enter Applications Search Criteria > Select values to refine search page. N/A
Table 3. Create Notification Wizard
Field Name Field Type Description Business Rules
  • Product Characteristics
  • Product Quantity Unit
  • Product Quantity Value
Drop-down list These fields are hidden by default on the Available Options drop-down list in Create Notification > Select Rule Settings and Delivery Destionation invoked from the Notifications tab on Pharmaceutical Product Attributes page. N/A
Administrable Dosage Form Drop-down list This field is renamed to Administrable Dose Form in the Available Options drop-down list in Create Notification > Select Rule Settings and Delivery Destionation invoked from the Notifications tab on Pharmaceutical Product Attributes page. N/A
Table 4. Global Project Plan Wizard
Field Name Field Type Description Business Rules
Indications/Intended Use Multi-select This field is renamed to Indications in the Select Indications/Intended Use > Select the indication/intended use tab of the Update Product Detail Set Project Type option. N/A