Calyx RIM for Analytics

XEVMPD Audit Report Results

The filter criteria you select define the data you get for the result set of the Report.

The following columns appear in the XEVMPD Audit Report:
  • Product Family Name
  • Application Name
  • License Code
  • Authorised Product Country
  • Authorised Product EV Code
  • FPP Name
  • Message Sender
  • Calyx RIM Action
  • XEVMPD Entity
  • InSight Entity Type
  • InSight Entity Name
  • Field Name
  • Field Data
  • Previous Field Data
  • Updated Date
  • User
  • Last Submitted Date (FPP)
  • Required XEVMPD Update
The following rules apply to the report results:
  • If the EEA Country is populated for the Full Product Presentation, then this value appears in the Authorised Product Country column. Otherwise, the Registration Issue Country is displayed.
  • The EV Code of the related Full Product Presentation entity appears in the Authorised Product EV Code column.
  • All fields from all entities for the XEVMPD Entity Type > Pharmaceutical Product - Active Ingredient appear if they are populated, regardless of the business logic: Component Active Ingredient, PDS Active Ingredient, Reference Active Ingredient and Substance Detail.
  • The Concatenation of the values appears in the InSight Entity Name column for the following fields:
    • MAH: MAH/Development Sponsor/Organisation Name + Address + City + Country Code
    • ATC: ATC Name + ATC Code
    • Active Ingredient, Exipient, and Adjuvant: [Name] + PP: [Pharmaceutical Product Name]
      Note: If the Pharmaceutical Product has been deleted, concatenation appears as [Name] + PP: No PP.