Ennov InSight RIM 7.1 RNs Cumulative

Query Fields and Columns Added: Ennov InSight 7.1

The following table describes fields that were updated with Ennov InSight 7.1.

Administration Queries

Table 1. Entity Audit Trail
Field/Column Name Field/Column Type Description
Entity Type Read-only text (populated automatically) The Manufactured Item value is added to the Entity Type field of the Entity Audit Trail Query to display details for the Manufactured Item entity type.
  • Manufactured Item ID
  • Manufactured Item ID
  • Manufactured Item Name
  • Manufactured Dose Form
  • Unit of Presentation
  • Manufactured Item Quantity
  • Manufactured Item Keywords
  • Manufactured Item Description
Read-only text (populated automatically) These columns are added to the Search Results page of the Entity Audit Trail Query to display details for the Manufactured Item entity type.
  • Manufacturer Operation Start Date
  • Manufacturer Operation Stop Date
Read-only text (populated automatically) The respective columns are displayed in the Search Results page of the Entity Audit Trail Query . These columns are displayed in the report from the Manufacturer Operation Start Date and Manufacturer Operation Stop Date fields of the Manufacturer page.
  • Package Set Pack Size Details Changed?
  • Package Set Pack Size Details QC Passed?
Read-only text (populated automatically) The respective fields are added to the Search Results page of the Entity Audit Trail Query to support the changes for PDS Pack Size Detail.
  • Package Item Container Quantity
  • Manufactured Item Reference
  • Packaging MI Quantity
  • Packaging MI Quantity Unit (Measurement)
  • Device Quantity
  • Medical Device Reference
Read-only text (populated automatically) The respective columns are added to the Search Results page of the Entity Audit Trail Query to display details for the Product Detail- Packaging entity type.

The values in the Manufactured Item Reference column are displayed as a concatenation of (Manufactured Item Name + Unit of Presentation + Manufactured Item Quantity + Manufactured Item Quantity Unit + Manufactured Item Dose Form + Manufactured Item Characteristics) All the values are separated with space.

The Medical Device Reference column is available for the Medical Device and PharmaMed Components only.

Combined Pharmaceutical Dose Form Read-only text (populated automatically) The Combined Pharmaceutical Dose Form column is added to Search Results page of the Product > Entity History Query.

Product Detail Management Queries

Table 2. Shelf Life Query
Field/Column Name Field Type Description
Component Name Read-only text (populated automatically) This column is now available in the Search Results page of the Shelf Life Query .
Table 3. Application QC Status History Report
Field/Column Name Field/Column Type Description
  • Packaging MI Quantity
  • Packaging MI Quantity Unit
  • Medical Device Reference
  • Device Quantity
  • Package Item Container Quantity
  • Package Material
  • Package Alternate Material
  • Package Components
  • Manufactured Item Reference
  • Intended effect
  • Comorbidity
  • Component Name
Read-only text (populated automatically) The respective columns are available on the Search Results page of the Application QC Status History Report .

The manufactured Item Reference column is available after you select the value under Package Component. There should be at least one Component with a MedDev or Pharma MedDev Type.

The values in the Manufactured Item Reference column are displayed as a concatenation of (Manufactured Item Name + Unit of Presentation + Manufactured Item Quantity + Manufactured Item Quantity Unit + Manufactured Item Dose Form + Manufactured Item Characteristics) All the values are separated with space.

The Intended Effect and Comorbidity columns are available after you select the value under Species Indications Details Changed? column for the Veterinary Product Family.

The Component Name column is available after you select the value under "Shelf Life(s)/Storage Condition(s) Changed column.

  • Package Set Pack Size Details Changed? (ASC, DESC)
  • Package Set Pack Size Details QC Passed?
Multi-select editable, Read-only text (populated automatically) The respective fields are now available in the Application QC Status History Report :
  • Display Columns multi-select field options
  • Sort Order multi-select field options
  • Search Results page
Table 4. Application History Query
Field/Column Name Field/Column Type Description
  • Packaging MI Quantity
  • Packaging MI Quantity Unit
  • Medical Device Reference
  • Device Quantity
  • Package Item Container Quantity
  • Package Material
  • Package Alternate Material
  • Package Components
  • Comorbidity
  • Intended Effect
  • Component Name
  • Manufactured Item Reference
Read-only text (populated automatically) The respective columns are available on the Search Results page of the Application History Query .

The Component Name column is available after you select the value under Shelf Life(s)/Storage Condition(s) Changed column.

The Manufactured Item Reference column is available after you select the value under Package Component. There should be at least one Component with a MedDev or Pharma MedDev Type.

The values in the Manufactured Item Reference column are displayed as a concatenation of (Manufactured Item Name + Unit of Presentation + Manufactured Item Quantity + Manufactured Item Quantity Unit + Manufactured Item Dose Form + Manufactured Item Characteristics) All the values are separated with space.

  • Package Set Pack Size Details Changed? (ASC, DESC)
  • Package Set Pack Size Details QC Passed?
Multi-select editable, Read-only text (populated automatically) The respective fields are now available in the Application History Query :
  • Display Columns multi-select field options
  • Sort Order multi-select field options
  • Search Results page
Table 5. List of Package Set Manufacturers
Field/Column Name Field/Column Type Description
  • Manufacturer Operation Start Date
  • Manufacturer Operation Stop Date
Multi-select editable, Read-only text (populated automatically) The respective fields are now available in the List of Package Set Manufacturers query:
  • Display Columns multi-select field options
  • Sort Order multi-select field options
  • Search Results page
Table 6. List of Component Manufacturers
Field/Column Name Field/Column Type Description
  • Manufacturer Operation Start Date
  • Manufacturer Operation Stop Date
Multi-select editable, Read-only text (populated automatically) The respective fields are now available in the List of Component Manufacturers query:
  • Display Columns multi-select field options
  • Sort Order multi-select field options
  • Search Results page
Table 7. List of PDS Manufacturers
Field/Column Name Field/Column Type Description
  • Manufacturer Operation Start Date
  • Manufacturer Operation Stop Date
Multi-select editable, Read-only text (populated automatically) This respective fields are now available in the List of PDS Manufacturers query:
  • Display Columns multi-select field options
  • Sort Order multi-select field options
  • Search Results page
Table 8. List of Excipient Manufacturers
Field/Column Name Field/Column Type Description
  • Manufacturer Operation Start Date
  • Manufacturer Operation Stop Date
Multi-select editable, Read-only text (populated automatically) The respective fields are now available in the List of Excipient Manufacturers query:
  • Display Columns multi-select field options
  • Sort Order multi-select field options
  • Search Results page
Table 9. List of Active Ingredient Material Manufacturers
Field/Column Name Field/Column Type Description
  • Manufacturer Operation Start Date
  • Manufacturer Operation Stop Date
Multi-select editable, Read-only text (populated automatically) The respective fields are now available in the List of Active Ingredient Material Manufacturers query:
  • Display Columns multi-select field options
  • Sort Order multi-select field options
  • Search Results page
Table 10. List of Active Ingredient Function Manufacturers
Field/Column Name Field/Column Type Description
  • Manufacturer Operation Start Date
  • Manufacturer Operation Stop Date
Multi-select editable, Read-only text (populated automatically) The respective fields are now available in the List of Active Ingredient Function Manufacturers query:
  • Display Columns multi-select field options
  • Sort Order multi-select field options
  • Search Results page
Table 11. List of Active Ingredient Manufacturers
Field/Column Name Field/Column Type Description
  • Manufacturer Operation Start Date
  • Manufacturer Operation Stop Date
Multi-select editable, Read-only text (populated automatically) The respective fields are now available in the List of Active Ingredient Manufacturers query:
  • Display Columns multi-select field options
  • Sort Order multi-select field options
  • Search Results page

Registration Planning and Tracking

Table 12. List of Pharmaceutical Products
Field/Column Name Field Type Description
  • Combined Pharmaceutical Dose Form
  • Product Category
  • EURD ID
  • IDMP Concentration Measure Type
IDMP Presentation Strength
  • Presentation Single or Low Limit Numerator Value
  • Presentation Single or Low Limit Unit of Measurement
  • Presentation Single or Low Limit Unit of Presentation
  • Presentation High Limit Numerator Value
  • Presentation High Limit Unit of Measurement
  • Presentation High Limit Unit of Presentation
IDMP Concentration Strength
  • Concentration Single or Low Limit Numerator Value
  • Concentration Single or Low Limit Unit of Measurement
  • Concentration Single or Low Limit Denominator Value
  • Concentration Single or Low Limit Unit of Measurement
  • Concentration High Limit Numerator Value
  • Concentration High Limit Unit of Measurement
  • Concentration High Limit Denominator Value
  • Concentration High Limit Unit of Measurement
Drop-down list, Multi-select editable, Text field, editable The respective fields/columns are now available in the List of Pharmaceutical Products query:
  • Display Columns multi-select field options
  • Sort Order multi-select field options
  • Search Results page
Table 13. List of Veterinary Products
Field/Column Name Field Type Description
  • IDMP Concentration Measure Type
IDMP Presentation Strength
  • Presentation Single or Low Limit Numerator Value
  • Presentation Single or Low Limit Unit of Measurement
  • Presentation Single or Low Limit Unit of Presentation
  • Presentation High Limit Numerator Value
  • Presentation High Limit Unit of Measurement
  • Presentation High Limit Unit of Presentation
IDMP Concentration Strength
  • Concentration Single or Low Limit Numerator Value
  • Concentration Single or Low Limit Unit of Measurement
  • Concentration Single or Low Limit Denominator Value
  • Concentration Single or Low Limit Unit of Measurement
  • Concentration High Limit Numerator Value
  • Concentration High Limit Unit of Measurement
  • Concentration High Limit Denominator Value
  • Concentration High Limit Unit of Measurement
Drop-down list, Text field, editable The respective fields/columns are now available in the List of Veterinary Products query:
  • Display Columns multi-select field options
  • Sort Order multi-select field options
  • Search Results page
Table 14. List of Pharmaceutical and Medical Device Products
Field/Column Name Field Type Description
  • Combined Pharmaceutical Dose Form
  • Product Category
  • EURD ID
  • IDMP Concentration Measure Type
IDMP Presentation Strength
  • Presentation Single or Low Limit Numerator Value
  • Presentation Single or Low Limit Unit of Measurement
  • Presentation Single or Low Limit Unit of Presentation
  • Presentation High Limit Numerator Value
  • Presentation High Limit Unit of Measurement
  • Presentation High Limit Unit of Presentation
IDMP Concentration Strength
  • Concentration Single or Low Limit Numerator Value
  • Concentration Single or Low Limit Unit of Measurement
  • Concentration Single or Low Limit Denominator Value
  • Concentration Single or Low Limit Unit of Measurement
  • Concentration High Limit Numerator Value
  • Concentration High Limit Unit of Measurement
  • Concentration High Limit Denominator Value
  • Concentration High Limit Unit of Measurement
Drop-down list, Multi-select editable, Text field, editable The respective fields/columns are now available in the List of Pharmaceutical and Medical Device Products query:
  • Display Columns multi-select field options
  • Sort Order multi-select field options
  • Search Results page
Table 15. List of Pharmaceutical Products and Components
Field/Column Name Field Type Description
  • Combined Pharmaceutical Dose Form
  • Product Category
  • EURD ID
  • IDMP Concentration Measure Type
IDMP Presentation Strength
  • Presentation Single or Low Limit Numerator Value
  • Presentation Single or Low Limit Unit of Measurement
  • Presentation Single or Low Limit Unit of Presentation
  • Presentation High Limit Numerator Value
  • Presentation High Limit Unit of Measurement
  • Presentation High Limit Unit of Presentation
IDMP Concentration Strength
  • Concentration Single or Low Limit Numerator Value
  • Concentration Single or Low Limit Unit of Measurement
  • Concentration Single or Low Limit Denominator Value
  • Concentration Single or Low Limit Unit of Measurement
  • Concentration High Limit Numerator Value
  • Concentration High Limit Unit of Measurement
  • Concentration High Limit Denominator Value
  • Concentration High Limit Unit of Measurement
Drop-down list,Text field, editable The respective fields/columns are now available in the List of Pharmaceutical Products and Components query:
  • Display Columns multi-select field options
  • Sort Order multi-select field options
  • Search Results page
Table 16. List of Veterinary Products and Components
Field/Column Name Field Type Description
  • IDMP Concentration Measure Type
IDMP Presentation Strength
  • Presentation Single or Low Limit Numerator Value
  • Presentation Single or Low Limit Unit of Measurement
  • Presentation Single or Low Limit Unit of Presentation
  • Presentation High Limit Numerator Value
  • Presentation High Limit Unit of Measurement
  • Presentation High Limit Unit of Presentation
IDMP Concentration Strength
  • Concentration Single or Low Limit Numerator Value
  • Concentration Single or Low Limit Unit of Measurement
  • Concentration Single or Low Limit Denominator Value
  • Concentration Single or Low Limit Unit of Measurement
  • Concentration High Limit Numerator Value
  • Concentration High Limit Unit of Measurement
  • Concentration High Limit Denominator Value
  • Concentration High Limit Unit of Measurement
Drop-down list, Text field, editable The respective fields/columns are now available in the List of Veterinary Products and Components query:
  • Display Columns multi-select field options
  • Sort Order multi-select field options
  • Search Results page
Table 17. List of Pharmaceutical and Medical Device Products and Components
Field/Column Name Field Type Description
  • Combined Pharmaceutical Dose Form
  • Product Category
  • EURD ID
  • IDMP Concentration Measure Type
IDMP Presentation Strength
  • Presentation Single or Low Limit Numerator Value
  • Presentation Single or Low Limit Unit of Measurement
  • Presentation Single or Low Limit Unit of Presentation
  • Presentation High Limit Numerator Value
  • Presentation High Limit Unit of Measurement
  • Presentation High Limit Unit of Presentation
IDMP Concentration Strength
  • Concentration Single or Low Limit Numerator Value
  • Concentration Single or Low Limit Unit of Measurement
  • Concentration Single or Low Limit Denominator Value
  • Concentration Single or Low Limit Unit of Measurement
  • Concentration High Limit Numerator Value
  • Concentration High Limit Unit of Measurement
  • Concentration High Limit Denominator Value
  • Concentration High Limit Unit of Measurement
Drop-down list, Multi-select editable, Text field, editable The respective fields/columns are now available in the List of Pharmaceutical and Medical Device Products and Components query:
  • Display Columns multi-select field options
  • Sort Order multi-select field options
  • Search Results page