Calyx RIM 6.2 Release Notes

New Fields Added: Calyx RIM 6.2 CHF 5

The following table describes fields that were added with Calyx RIM 6.2 CHF 5.


Field Name	Field Type	Entity Name	Description	Business Rules
Created By	Username	All the SPOR Maintenance values in Data Administration	Created By has been added to ensure the visibility of who added the values.	You can use the Created By field to define by whom a SPOR Maintenance value was created, either via automated updates from the EMA or manually by Data Administration users. By default, this option is read-only. It is populated automatically when updates are made to the table.
Created Date	dd-mmm-yyyy	All the SPOR Maintenance values in Data Administration	The field Created Date has been added to ensure visibility of when the values are added.	You can use the Created Date field to define when a SPOR Maintenance value was created. By default, this option is read-only. It is populated automatically when updates are made to the table.
DMS Versioning Scheme	Radio button	Import from eCTD option, on the Application page.	DMS Versioning Scheme has been added to provide functionality related to EAEU regulatory updates.	You can use DMS Versioning Scheme to import EAEU submissions. See: Calyx RIM Best Practice: EAEU Submissions.
EAEU XML with embedded PDFs	Drop-down list	Import from eCTD option, on the Application page.	EAEU XML with embedded PDFs has been added to provide the functionality related to EAEU regulatory updates.	You can use EAEU XML with embedded PDFs to import EAEU submissions. See: Calyx RIM Best Practice: EAEU Submissions.
EAEU XML Location	Browse button	Import from eCTD option, on the Application page.	EAEU XML Location has been added to provide the functionality related to EAEU regulatory updates.	You can use EAEU XML Location to import EAEU submissions. See: Calyx RIM Best Practice: EAEU Submissions.
Embed PDFs into EAEU XML?	Check box	Embed PDFs into EAEU XML? option, on the Export Published Output page.	Embed PDFs into EAEU XML? has been added to provide functionality related to EAEU regulatory updates.	You can use Embed PDFs into EAEU XML? to export EAEU submissions. See: Calyx RIM Best Practice: EAEU Submissions.
Last User Updated	Username	All the entities and grids in Data Administration.	Last User Updated has been added to identify historical audit trails.	You can use the Last User Updated field to define by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	dd-mmm-yyyy	All the entities and grids in Data Administration.	Last Changed Date has been added to identify a historical audit trail within user interface.	You can use the Last Changed Date field to define when a Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Mass Update	Action button	Indications/Intended Use	Mass Update enables you to update a MedDRA version for multiple indications/intended entities simultaneously.	You can use Mass Update to enter a MedDRA version. You can then use the option Update and Overwrite to update the new version for all selected Indications or use Update and Preserve to update the new version for only those selected Indications which have no values.
Optimize Font in Paper Output	Drop-down list	Publishing Settings Library	Optimize Font in Paper Output has been added to Publishing Settings Library.	Minimize font compatibility issues and provide stability to the process of printing the paper output. By default, the value is No. All assemblies migrated from a previous Calyx RIM version will have Optimize Fonts in Paper Output set to No.
Output Document Type	Drop-down list	Import from eCTD option, on the Application page.	Output Document Type has been added to provide the functionality related to EAEU regulatory updates.	You can use Output Document Type to import EAEU submissions. See: Calyx RIM Best Practice: EAEU Submissions
System Process Default Flag	Drop-down list	The following entities in Data Administration Application > Application Status Values Event > Event-Change Detail Status Values Product > Product Status Values Product > Product Detail Set Status Values Sequence > Sequence Status Values	If you assign several display statuses to the same Internal System Status in Data Administration, the System Process Default Flag enables you to select the display status to show for Application, Product, Event-Change Detail, or Sequence after the Event is closed manually or via the wizard.	You can use System Process Default Flag to define the display status in the Name field which will be displayed after the Event is closed manually or via the wizard, provided that the appropriate Internal System Status is mapped to that display status.
XEVMPD Submission Required?	Drop-down list	Full Product Presentations	XEVMPD Submission Required? enables you to categorize the Full Product Presentations that are ready to be submitted to XEVMPD.	When creating or copying Full Product Presentations, the value of this field is automatically set to `Yes`. This indicates that the XEVMPD data is ready to be submitted.

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New Fields Added: Calyx RIM 6.2 CHF 5

The following table describes fields that were added with Calyx RIM 6.2 CHF 5.


Field Name	Field Type	Entity Name	Description	Business Rules
Created By	Username	All the SPOR Maintenance values in Data Administration	Created By has been added to ensure the visibility of who added the values.	You can use the Created By field to define by whom a SPOR Maintenance value was created, either via automated updates from the EMA or manually by Data Administration users. By default, this option is read-only. It is populated automatically when updates are made to the table.
Created Date	dd-mmm-yyyy	All the SPOR Maintenance values in Data Administration	The field Created Date has been added to ensure visibility of when the values are added.	You can use the Created Date field to define when a SPOR Maintenance value was created. By default, this option is read-only. It is populated automatically when updates are made to the table.
DMS Versioning Scheme	Radio button	Import from eCTD option, on the Application page.	DMS Versioning Scheme has been added to provide functionality related to EAEU regulatory updates.	You can use DMS Versioning Scheme to import EAEU submissions. See: Calyx RIM Best Practice: EAEU Submissions.
EAEU XML with embedded PDFs	Drop-down list	Import from eCTD option, on the Application page.	EAEU XML with embedded PDFs has been added to provide the functionality related to EAEU regulatory updates.	You can use EAEU XML with embedded PDFs to import EAEU submissions. See: Calyx RIM Best Practice: EAEU Submissions.
EAEU XML Location	Browse button	Import from eCTD option, on the Application page.	EAEU XML Location has been added to provide the functionality related to EAEU regulatory updates.	You can use EAEU XML Location to import EAEU submissions. See: Calyx RIM Best Practice: EAEU Submissions.
Embed PDFs into EAEU XML?	Check box	Embed PDFs into EAEU XML? option, on the Export Published Output page.	Embed PDFs into EAEU XML? has been added to provide functionality related to EAEU regulatory updates.	You can use Embed PDFs into EAEU XML? to export EAEU submissions. See: Calyx RIM Best Practice: EAEU Submissions.
Last User Updated	Username	All the entities and grids in Data Administration.	Last User Updated has been added to identify historical audit trails.	You can use the Last User Updated field to define by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	dd-mmm-yyyy	All the entities and grids in Data Administration.	Last Changed Date has been added to identify a historical audit trail within user interface.	You can use the Last Changed Date field to define when a Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Mass Update	Action button	Indications/Intended Use	Mass Update enables you to update a MedDRA version for multiple indications/intended entities simultaneously.	You can use Mass Update to enter a MedDRA version. You can then use the option Update and Overwrite to update the new version for all selected Indications or use Update and Preserve to update the new version for only those selected Indications which have no values.
Optimize Font in Paper Output	Drop-down list	Publishing Settings Library	Optimize Font in Paper Output has been added to Publishing Settings Library.	Minimize font compatibility issues and provide stability to the process of printing the paper output. By default, the value is No. All assemblies migrated from a previous Calyx RIM version will have Optimize Fonts in Paper Output set to No.
Output Document Type	Drop-down list	Import from eCTD option, on the Application page.	Output Document Type has been added to provide the functionality related to EAEU regulatory updates.	You can use Output Document Type to import EAEU submissions. See: Calyx RIM Best Practice: EAEU Submissions
System Process Default Flag	Drop-down list	The following entities in Data Administration Application > Application Status Values Event > Event-Change Detail Status Values Product > Product Status Values Product > Product Detail Set Status Values Sequence > Sequence Status Values	If you assign several display statuses to the same Internal System Status in Data Administration, the System Process Default Flag enables you to select the display status to show for Application, Product, Event-Change Detail, or Sequence after the Event is closed manually or via the wizard.	You can use System Process Default Flag to define the display status in the Name field which will be displayed after the Event is closed manually or via the wizard, provided that the appropriate Internal System Status is mapped to that display status.
XEVMPD Submission Required?	Drop-down list	Full Product Presentations	XEVMPD Submission Required? enables you to categorize the Full Product Presentations that are ready to be submitted to XEVMPD.	When creating or copying Full Product Presentations, the value of this field is automatically set to `Yes`. This indicates that the XEVMPD data is ready to be submitted.