Ennov InSight 7.1 Component Active Ingredients Updates

New features and fields are included in Ennov InSight 7.1 to conform to the regulatory requirements.

Component Active Ingredient

In Ennov InSight 7.1, the Component Active Ingredient is created one-by-one and not in bulk. This is because of the change in cardinality between the Component Active Ingredient and the Reference Active Ingredient.

The following strength fields to indicate IDMP strength values are added to the Component Active Ingredient, placed under the XEVMPD strength fields divided by the UI separator:
  • 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

In Ennov InSight 7.1 , the grid view for this entity is updated.

Component Reference Active Ingredient

In Ennov InSight 7.1, multiple Reference Active Ingredients can be created for one Component Active Ingredient as required. The Reference Active Ingredients tab is available on the Active Ingredient Attributes window.

The following strength fields are added to the Component Active Ingredient to indicate IDMP strength values. The strength fields are placed under the XEVMPD and divided by the UI separator:
  • 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