Calyx RIM for Analytics

XEVMPD Audit

The XEVMPD Audit report provides a mechanism for Calyx RIM users to view the XEVMPD entities fields action information that has been added, updated, or deleted to be able to send their updates to the agency in time based on the provided data.

  • The report results are displayed based on the entered filter criteria.
  • All Data Administration values, regardless of the Active or Inactive state, are displayed and available for selection.
  • If the Calyx RIM system is unable to return any results based on the selected filter criteria, an appropriate message appears.
  • The selected filters that do not contain any data, for example due to the associated dependencies or due to nonexistent in the database data, are available but appear blank.
  • The fields that do not contain any data appear without content in the report output.
  • The report captures the Insert, Update, and Delete actions performed on the XEVMPD-related entities and its subsequent attributes.
  • The filters XEVMPD Entity Type and InSight Entity Type are multi-select fields.
  • The PDS-related entities are displayed in the report output only if the PDS Detail has the Approved status.
  • Values for the fields with NULL in both Field Data and Previous Field Data fields do not appear in the report layout.
  • The hyperlinks to Calyx RIM entities are provided by clicking on the InSight Entity Name column value and selecting Entity Details option from the pop-up list. The link leads you to the entity for which the link is initiated.
    Note: The exceptions are:
    • PDS Details, where the link leads to the PDS itself.
    • Active Ingredient entity does not have the hyperlink.
The InSight Entity Name is displayed as a concatenation of values for the following entities:
  • MAH
    • MAH/Development Sponsor/Organisation Name + Address + City + Country Code
  • ATC
    • ATC Name + ATC Code
  • Active Ingredient, Excipient, and Adjuvant
    • [Name] + PP: [Pharmaceutical Product Name]
      Note: If the Pharmaceutical Product has been deleted, concatenation is shown as [Name] + PP: No PP.
The XEVMPD Audit report captures the following for all actions on subsequent fields for the XEVMPD-related entities:
  • The user that makes the changes
  • The date the changes were made
  • The content of changes
  • The changed entity
  • The XEVMPD entity name
  • The related entity type and name
The filters that can be used for the XEVMPD Audit report:
Filter Field Description
User Multi-select field that is defaulted to ALL value. You can select as many users as needed.
Last Updated Date The date of last update. The default value is set to 6 months from today's date.
XEVMPD Submission required? The Yes and No values are available for selection. The field is empty by default. The values are calculated using the formula:
  • Yes value means that the Last Updated Date is greater than the Date Submitted to EMA.
  • No value means that the Last Updated Date is less than the Date Submitted to EMA.

The field default is to display ALL (all listed values).

XEVMPD Entity Type Multi-select field with the following values available for selection:
  • Authorised Product - ATC
  • Authorised Product - Authorisation
  • Authorised Product - Authorised Pharmaforms
  • Authorised Product - Medicinal Product Type
  • Authorised Product - Presentation Name
  • Authorised Product - Previous EV Code
  • Authorised Product - Printed Product Information
  • Authorised Product - Product Indications
  • Authorised Products
  • Pharmaceutical Product
  • Pharmaceutical Product - Active Ingredient
  • Pharmaceutical Product - Adjuvant
  • Pharmaceutical Product - Administration Route
  • Pharmaceutical Product - Excipient
  • Pharmaceutical Product - Medical Devices

Only values with the selected data are displayed in the search results table. The field default is to display ALL (all listed sections).

InSight Entity Type Multi-select field with the following values available for selection:
  • Adjuvant
  • Application
  • Component
  • Component Active Ingredient
  • Excipient
  • Full Product Presentation
  • Indications/Intended Use
  • Package Set Registration
  • PDS
  • PDS Active Ingredient
  • PDS Substance
  • Pharmaceutical Product
  • Product
  • Reference Active Ingredient
  • Registration FPP Attachment

The field default is to display ALL (all listed sections).

InSight Entity Name Text field that is defaulted to be empty. Leaving the field without specifying any filtering criteria will display all available entities on the results page.
Product Family Name Text field that is defaulted to be empty. Leaving the field without specifying any filtering criteria will display all available entities on the results page.
Message Sender Text field that is defaulted to be empty. Leaving the field without specifying any filtering criteria will display all available entities on the results page.
Calyx RIM Action Type Multi-select field with the following values available for selection:
  • Insert
  • Update
  • Delete

The field default is to display ALL (all listed sections).

The selection rules that are applicable to the XEVMPD Entity Type and InSight Entity Type:
XEVMPD Entity Type InSight Entity Type
Authorised Product - ATC Package Set Registration
Authorised Product - Authorisation Application
Authorised Product - Authorisation Full Product Presentation
Authorised Product - Authorisation Package Set Registration
Authorised Product - Authorisation PDS
Authorised Product - Authorised Pharmaforms Full Product Presentation
Authorised Product - Medicinal Product Type Package Set Registration
Authorised Product - Presentation Name Full Product Presentation
Authorised Product - Previous EV Code Full Product Presentation
Authorised Product - Printed Product Information Registration FPP Attachment
Authorised Product - Product Indications Indications/Intended Use
Authorised Products Full Product Presentation
Authorised Products Package Set Registration
Pharmaceutical Product Pharmaceutical Product
Pharmaceutical Product - Active Ingredient Component Active Ingredient
Pharmaceutical Product - Active Ingredient PDS Active Ingredient
Pharmaceutical Product - Active Ingredient PDS Substance
Pharmaceutical Product - Active Ingredient Reference Active Ingredient
Pharmaceutical Product - Adjuvant Adjuvant
Pharmaceutical Product - Administration Route Component
Pharmaceutical Product - Administration Route Product
Pharmaceutical Product - Excipient Excipient
Pharmaceutical Product - Medical Devices Pharmaceutical Product
Entities from the following list are displayed in the XEVMPD Audit analytics report only if the appropriate Package Set is associated to the corresponding Full Product Presentation:
XEVMPD Entity Type InSight Entity Type
Authorised Product - Authorisation PDS
Authorised Product - Product Indications Indications/Intended Use
Pharmaceutical Product Pharmaceutical Product
Pharmaceutical Product - Active Ingredient Component Active Ingredient
Pharmaceutical Product - Active Ingredient PDS Active Ingredient
Pharmaceutical Product - Active Ingredient PDS Substance
Pharmaceutical Product - Active Ingredient Reference Active Ingredient
Pharmaceutical Product - Adjuvant Adjuvant
Pharmaceutical Product - Administration Route Component
Pharmaceutical Product - Administration Route Product
Pharmaceutical Product - Excipient Excipient
Pharmaceutical Product - Medical Devices Pharmaceutical Product