Entity Fields, Columns and Options Updated: Ennov InSight 7.3.4

The following tables describe fields, columns and options that were modified in this release.

Medicinal Product Name

Field/Option

Name

 Field Type Description Business Rules
Full Name Text area The field type is changed from Text to Text area for Medicinal Product. The change allows up to 4000 characters to be entered for the Medicinal Product name.
PDS Component

Field/Option

Name

 Field Type Description Business Rules
Origin of Substance Drop-down By default, these fields are hidden on the PDS Component > Active Ingredient Details and PDS Component > Substance Details pages.

 These fields are hidden as they are available now on Pharmaceutical Product and Manufactured Item.

Composition Grouping Description

 Text

Presentation Strength

The table below provides details of the changes made to the Presentation Strength fields to conform to EMA's requirements.

Existing Field Name Existing Field Type Change New Field Name New Field Type Affected Entities
Concentration Measure Type Drop-down Field name changed Strength (Presentation) Quantity Operator Drop-down (no change) These Presentation Strength fields are updated for the following entities:
  • Component Active Ingredient
  • Component Reference Active Ingredient
  • Manufactured Item Active Ingredient
  • Manufactured Item Reference Active Ingredient
  • Pharmaceutical Product Active Ingredient
  • Pharmaceutical Product Reference Active Ingredient
  • Manufactured Item Substance
  • Manufactured Item Reference Substance
  • Pharmaceutical Product Substance
  • Pharmaceutical Product Reference Substance
  • Product Detail Set Substance Details
  • Product Detail Set Flu Strain Details

Presentation Single or Low Limit Numerator Value

Text

Field name and type changed

 Presentation Single/Low Limit  Numerator Value String

Presentation Single or Low Limit Unit of Measurement

Drop-down Field name changed

Presentation Single/Low Limit Numerator Unit of Measurement

Drop-down (No change)

Presentation Single or Low Limit Unit of Presentation

Drop-down Field name changed

This field is hidden by default.

DP Presentation Single or Low Limit Unit of Presentation

Drop-down (No change)

Presentation High Limit Numerator Value

Text Field type changed

Presentation High Limit Numerator Value

String

Presentation High Limit Unit of Measurement

 Drop-down Field name changed

Presentation High Limit Numerator Unit of Measurement

Drop-down (no change)

Presentation High Limit Unit of Presentation

Drop-down Field name changed.

This field is hidden by default.

DP Presentation High Limit Unit of Presentation

Drop-down (no change)

Concentration Strength

The table below provides details of the changes made to the Concentration Strength fields to conform to EMA's requirements.

Existing Field Name Existing Field Type Change New Field Name New Field Type Entities Affected
Concentration Measure Type Drop-down Field name changed Strength (Concentration) Quantity Operator Drop-down (no change) These Concentration Strength fields are updated for the following entities:
  • Component Active Ingredient
  • Component Reference Active Ingredient
  • Manufactured Item Active Ingredient
  • Manufactured Item Reference Active Ingredient
  • Pharmaceutical Product Active Ingredient
  • Pharmaceutical Product Reference Active Ingredient
  • Manufactured Item Substance
  • Manufactured Item Reference Substance
  • Pharmaceutical Product Substance
  • Pharmaceutical Product Reference Substance
  • Product Detail Set Substance Details
  • Product Detail Set Flu Strain Details

Concentration Single or Low Limit Numerator Value

Text

Field name and type changed

 Concentration Single/Low Limit  Numerator Value String

Concentration Single or Low Limit Unit of Measurement

Drop-down Field name changed

Concentration Single/Low Limit Numerator Unit of Measurement

Drop-down (No change)
Concentration Single or Low Limit Denominator Value Numeric Field name Concentration Single/Low Limit Denominator Value Numeric

Concentration Single or Low Limit Unit of Measurement

Drop-down Field name changed.

Concentration Single/Low Limit Denominator Unit of Measurement

 Drop-down (No change)

Concentration High Limit Numerator Value

Text Field type changed

Concentration High Limit Numerator Value

String

Concentration High Limit Unit of Measurement

 Drop-down Field name changed

Concentration High Limit Numerator Unit of Measurement

Drop-down (no change)

Concentration High Limit Unit of Measurement

 Drop-down Field name changed.

 Concentration High Limit Numerator Unit of Measurement Drop-down (no change)

Concentration High Limit Unit of Measurement

 Drop-down

Field name changed.

Concentration High Limit Denominator Unit of Measurement

 Drop-down (no change)

PDS Packaging Detail

Field/Option

Name

 Field Type Description Business Rules
Package Item - MI Quantity Unit Drop-down Values from both Unit of Presentation and Unit of Measurement Data Administration are displayed for quantity unit fileds. The change is made to support IDMP data capture.
Device Quantity Unit Drop-down The field Device Quantity Unit of Presentation is now renamed to Device Quantity Unit and shows values from Unit of Presentation Values and Units of Measurement. The change is made to comply with EMA's implementation of the ISO standards for IDMP.

Manufacturer Value

The Manufacturer value now displays as a concatenation of Manufacturer Name + Address Line + Country Code + (Location ID, when associated to OMS and Location ID Status when not active) in the following locations.

Affected Area Entity/Wizard/Query Location Field name
Entities Comparator Add/Modify/View screen Supplier
PDS: Manufacturer Details Add/Modify/View screen Manufacturer
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