Ennov InSight 7.1 Data Migration Documentation

Ennov InSight 7.1 PDS and PDS Template Updates

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

PDS Component Node

In Ennov InSight 7.1, the Pharmaceutical Product field is no longer available on the Component Attributes page on the PDS.

PDS Active Ingredient Detail

In Ennov InSight 7.1, the XEVMPD strength fields are view-only with the data taken from the Component Active Ingredient under the Product.

The Active Ingredient node is now created automatically within the PDS.

See Pre-Migration Scripts section for details on how to prepare your data for migration to v7.1.

PDS Substance Detail

The following strength fields to indicate IDMP strength values are added to the Component Active Ingredient 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

PDS Indications/Intended Use Detail

In Ennov InSight 7.1, Indications/Intended Use details are created one at a time and not in bulk.

To support IDMP, Ennov InSight 7.1 now includes the following updates:
  • Indications/Intended Use - This field is renamed to Indications.
  • Product Family Comorbidity - This is a new multi-select field added to the Product Family.
  • Intended Effect - This is a new multi-select field added with the values from Data Administration.

PDS Manufacturer Detail

To support IDMP, Ennov InSight 7.1 now includes the new fields:
  • Manufacturing Operation Start Date, This is a new date field under Manufacturer Status Date and has a NULL value after migration.
  • Manufacturing Operation Stop Date This is a new date field under Manufacturing Operation Start Date and has a NULL value after migration.

PDS Packaging Detail

To support IDMP, Ennov InSight 7.1 now includes the following updates:
  • Package Item Container Quantity This is a new numeric field under the Packaging Type field.
  • The Container Package Material - This field is renamed to Package Material.
  • The Container Package Alternate Material - This field is renamed to Package Alternate Material.
  • Package Components - This is a new multi-select field and added under the Unit of Presentation field
  • Manufactured Item Reference This is a new multi-select field and added under the Package Components field.
  • Packaging MI Quantity - This is a new numeric field and added under the Manufactured Item Reference.
  • Packaging MI Quantity Unit - This is, a new drop-down list added under the Packaging MI Quantity.
  • Medical Device Reference - This is a new drop-down list added under the Packaging MI Quantity Unit field. This field is, available for Medical Devices and Pharma-Med Device components.

PDS Shelf Life Detail

In Ennov InSight 7.1, one common Shelf Life Node is available - Shelf Life(s)/Storage Condition(s). If there is more than one Component for the PDS, the Shelf Life(s)/Storage Condition(s) node will be shown under each Component.

Unicity is updated to include concatenation of the following fields:
  • Shelf Life Type
  • Shelf Life
  • Shelf Life Unit
  • Shelf Life Category

Shelf Life Type is now a required field. This is available under the Product Detail Set Name field and available in the PDS Tree before the PDS Details Status.

The following migration rules apply:
  • If the Shelf Life(s)/Storage Condition(s) Node is present before migration, it will migrate to the Shelf Life(s)/Storage Condition(s) with the Shelf Life Type with Code Name in original pack.
  • If there is a Shelf Life(s)/Storage Condition(s) After Opening Node before migration, it will migrate with the Shelf Life Type with Code Name ‘After first opening’
  • If there is a Shelf Life(s)/Storage Condition(s) After Reconstitution Node before migration, it will migrate with the Shelf Life Type with Code Name ‘After transformation’.
  • If any of the nodes have a value in the Shelf Life Type before migration it will be added to the Comments field on the entity.
  • It is now possible to update the fields on the Shelf Life while the node is still in Pending Add status.
Note: Verify the Shelf Life Type field appears on the user interface. Else, contact your Business Development Representative for assistance.

PDS Flu Strain Detail

The following strength fields to indicate IDMP strength values are added to the Flu Strain detail and 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

PDS Pack Size Detail

To support IDMP, Ennov InSight 7.1 now includes a new PDS Node Pack Size as a child of Package Set Node.