Calyx RIM 6.2 Release Notes

List of Enhancements: Calyx RIM 6.2 CHF 7

Requested new features and enhancements are included in each release. The items are listed in descending order by their tracking numbers. Customer case numbers that were recorded when the enhancements were requested are included in brackets [#####] following the tracking number.
Issue Affected Area Build Hotfix Build Description
26747 Assembly 6.2.0.7.0006 N/A Calyx RIM 6.2 now supports Taiwan eCTD Module 1 Version 1.1.
26700 Assembly 6.2.0.7.0006 N/A US 3.3 assembly templates now support eCTD specification v.2.5 and include:
  • the updated xml generation to use https instead of http in dtd reference and stylesheet.
  • two additional folders with US Forms extension:
    • 1.1.10 Form FDA 3988: Transmittal of PMR/PMC Submissions for Drugs and Biologics
    • 1.1.11 Form FDA 3938: Drug Master File
  • fdaft10 and fdaft11 Application Form Type Values
  • REMS Supplement Filing Type with NDA, BLA and ANDA application types for Grouped Submissions.
26698 Assembly 6.2.0.7.0006 6.2.0.6.0022 The EU National 3.0.3 template is now enabled in the Сreate eCTD Wizard for the Great Britain and United Kingdom regions .
26694 Assembly 6.2.0.7.0006 6.2.0.6.0025 User authentication is now introduced for permission based access to OpenText Content Server (formerly Livelink), SharePoint, Documentum, and Secure File System repositories when the following actions are performed:
  • View File on a document, leaf, or volume
  • View File in Link Inspector
  • Edit Document Links

If the user does not have sufficient permissions to access the document in the DMS, the user will not be able to access the document via the user interface.

26688 Application 6.2.0.7.0006 6.2.0.6.0022 The Application UUID is now unique within a regulatory region, instead of being unique within the system.
26686 Application 6.2.0.7.0006 N/A You can record comments for create/modify actions on Event - Country, Sequence Status Date, and Task Status Dates.
  • Event-Country Status Comments in Event- Country Attributes > Add/Modify-Country Event Status.
  • Sequence-Status Comments in View Sequence > Add/Modify Status.
  • Task Status Comments in View Task > Add/Modify Status.
Note: Comments on status are not modified/deleted by Admin.
26682 XEVMPD 6.2.0.7.0006 6.2.0.6.0022 The XEVMPD Wizard is updated to support the EMA XEVMPD requirement for BREXIT to generate 'XI' as the Authorisation country code in the EVPRM message for all United Kingdom registrations.
26681 Application 6.2.0.7.0006 6.2.0.6.0022 The UUID field is now available on View and Edit Application pages for the United Kingdom and Great Britain regions.
26674 XEVMPD 6.2.0.7.0006 6.2.0.6.0022 The United Kingdom country is now available for selection in the Country field in the Authorized Product Selection tab of the XEVMPD Submission wizard.