Ennov InSight 7.2 Release Notes (Cumulative)

New in Ennov InSight 7.2: Common Functionality

This table shows new features and enhancements of Ennov InSight 7.2 functionality.

Identification of Medicinal Products (IDMP)

To capture additional data elements for European Medicine Agency (EMA) implementation of IDMP.

Affected Area Update Benefit
Entities/Entity tabs Changes for IDMP now include:
  • Entity updates:
    • Product Family updates. See: Entity Fields and Columns Updated: Ennov InSight 7.2, Entity Fields and Columns Removed: Ennov InSight 7.2 and Registrations > Product Family Attributes .
    • СT Shared Data updates. See: Registrations > Product Family > CT Shared Data Attributes and Entity Fields and Columns Added: Ennov InSight 7.2
    • Application updates. See: Entity Fields and Columns Added: Ennov InSight 7.2, Entity Fields and Columns Removed: Ennov InSight 7.2
    • Medicinal Product Name. See: Entity Fields and Columns Added: Ennov InSight 7.2, Entity Fields and Columns Updated: Ennov InSight 7.2, Registrations > Medicinal Product Name.
    • Manufactured Item fields and columns updates. See: Entity Fields and Columns Added: Ennov InSight 7.2 and Entity Fields and Columns Updated: Ennov InSight 7.2 and Registrations > Manufactured Item.
    • Pharmaceutical Product Updates (PhPIDs). Entity Fields and Columns Added: Ennov InSight 7.2 and and Registrations > PhPID Attributes
    • Registration-Package Sets fields updates. See: Entity Fields and Columns Added: Ennov InSight 7.2, Entity Fields and Columns Updated: Ennov InSight 7.2 and Registrations > Registration Package Set Attributes.
    • Registration-Package Set-Country fields updates. See: Entity Fields and Columns Updated: Ennov InSight 7.2 and Registrations > Registration -Package Set - Country Attributes.
    • Registration-Package Set-Package Description fields updates. See: Entity Fields and Columns Updated: Ennov InSight 7.2 and Registrations > Registration -Package Set - Package Description Attributes.
    • PDS Package Detail fields updates. See: Entity Fields and Columns Added: Ennov InSight 7.2 and Entity Fields and Columns Updated: Ennov InSight 7.2 and Registrations > PDS Package Detail Attributes.
    • Event updates. See: Entity Fields and Columns Added: Ennov InSight 7.2 and Registrations > Events > Pending Changes.
    • Medicinal Product updates. See: Entity Fields and Columns Added: Ennov InSight 7.2, Entity Fields and Columns Updated: Ennov InSight 7.2,Entity Fields and Columns Removed: Ennov InSight 7.2,Registrations > Medicinal Product Attributes and Registrations > Events > Pending Changes.
    • Medicinal Product Action updates. See: Entity Fields and Columns Added: Ennov InSight 7.2, Entity Fields and Columns Updated: Ennov InSight 7.2, Entity Fields and Columns Removed: Ennov InSight 7.2.
    • Active Ingredients and Reference Active Ingredients for Component, Pharmaceutical Product, Manufactured Item, PDS Details (Active Ingredients, Substance​​​​, Flu Strain, Packaging). See: Entity Fields and Columns Added: Ennov InSight 7.2, Entity Fields and Columns Updated: Ennov InSight 7.2 and Registrations > Active Ingredients Attributes , Registrations > Reference Active Ingredients Attributes, ,Registrations > Flu Strain Attributes, Registrations > Substance PDS Attributes.
    • Substances and Reference Substances for Pharmaceutical Product, Manufactured Item. See: Entity Fields and Columns Added: Ennov InSight 7.2, Entity Fields and Columns Updated: Ennov InSight 7.2 and Registrations > Substance Attributes , Registrations > Reference Substance Attributes
  • Tab updates:
    • My Home. See:Entity Fields and Columns Added: Ennov InSight 7.2
Data Administration To conform to latest IDMP standards, the following updates have been made to Data Administration:
  • The Packaging Category Values table in Data Administration > Product Detail Set Maintenance is updated with new fields. See: Data Administration Tables Updated: Ennov InSight 7.2.
  • New SMS tab for SPOR SMS Substance mapping in Data Administration > Product Family Maintenance > Substance Values
  • New Term Search selection widget to associate SPOR SMS Substance to Substance Values.
  • New RMS tab for SPOR Regulatory Entitlement Status mapping in Data Administration > Registration Maintenance > Registration Status Values.
  • New RMS tab for Units of Measurement RMS list mapping in Data Administration > Product Detail Set Maintenance > Time Unit Values.
  • New Certificate Master File Values table in Data Administration > Other .
  • New File Identifier Type Values table in Data Administration > Other .
  • New Origin of Substance Values table in Data Administration > Product Detail Set Maintenance .
  • Product Detail Set Maintenance > Manufacturer Values > Global Product Details updates. See: Data Administration Tables Updated: Ennov InSight 7.2
  • Product Detail Set Maintenance > Manufacturer Values > Manufacturing Authorization Reference Number updates. See: Data Administration Tables Updated: Ennov InSight 7.2
  • OMS Term widget fields updates. See: Data Administration Tables Updated: Ennov InSight 7.2.
  • The Data Administration values are updated to include the RMS Term ID, RMS Modified On, and RMS Status columns. The Data Administration columns will display values only if the RMS Term is associated. The values for these columns are displayed from the SPOR Master List as listed below. See: Data Administration Tables Updated
    • For RMS Term ID: The term id is displayed from the SPOR Master List.
    • For RMS Modified On: The modified date is displayed from the operational attributes of the SPOR Master List.
    • For RMS Status: The status of the term is displayed from the SPOR Master List.

You can associate or disassociate RMS Terms for Registration Maintenance > Risk of Shortage of Supply Reason Values with SPOR Master List > Reason of Marketing Unavailability List value.

Data Administration now includes a new Medical Device Maintenance section. Filter option is available for all the Medical Device Values. See Data Administration > Medical Device Maintenance: Medical Device Values

Security Administration To conform to the latest IDMP standards, the following updates have been made to Security Administration:
  • Fields renamed: See: Security Administration Tables Updated
  • For a user to have access to Medicinal Product and Medicinal Product Actions, an administrator can now grant user access for RPT and PDM users to: Entity Security:
    • Medicinal Product
    • Medicinal Product Actions
    • Home Page Access:
      • Medicinal Product
      • Medicinal Product Actions
Security Administration functionality is updated to align with the updated data model for IDMP.
Querying To conform to IDMP standards, Queries now include updated list of IDMP Presentation Strength and IDMP Concentration Strength fields for Registration Planning and Tracking. See: Query Fields and Columns Added: Ennov InSight 7.2, Query Fields and Columns Updated: Ennov InSight 7.2.