Calyx RIM 6.2 Release Notes

Calyx RIM 6.2 CHF 5 Release Notes

This document describes a certified hotfix (CHF) provided to improve Calyx RIM 6.2.

In addition to enhanced features and functionality, Calyx RIM 6.2 CHF 5 resolves issues that were reported to Technical Support. Our hotfixes are cumulative packages applied to a named version of our software.

As a certified hotfix, these updates have undergone Quality Control regression testing, certifying the system works as expected. These changes will not create a new code branch, but will be identified by the updated build number on the existing codeline of each version affected, not a new release number.

Overrides Updates

Calyx RIM 6.2 CHF 5 requires overrides updates. Please allow 6 to 8 weeks for XML overrides review and updates. For details, please contact your Business Development Representative to consult with our Client Enablement team.

Browser Support Update

Calyx RIM 6.2 CHF 5 adds support of Microsoft Edge based on Chromium. See Calyx RIM 6.2 System Support Document (SSD) for more details.

Database Server Specification Update

Calyx RIM 6.2 CHF 5 requires one of these Oracle versions:
  • Oracle 19c (12.2.0.3) - 12.2.0.3.0 Standard Edition 2
  • Oracle 19c (12.2.0.3) - 12.2.0.3.0 Enterprise Edition

Regulatory Updates

Calyx RIM 6.2 CHF 5 introduces functionality related to the following regulatory updates:
  • CH eCTD Module 1 Version 1.5
  • EAEU 1.0:
    • Embed PDF content into submission XML
    • eCTD import for submissions with embedded PDF content and submissions with PDF file references from the submission XML
    • Solvent metadata for the submission XML
    • Create separate folders based on the Substance and Solvent metadata
    • Auto-populate the Output Folder with the metadata values from Solvent and Drug Substance extensions
    • Bulk eCTD Import is not supported
    • Create Study Reports Wizard is not supported

Data Administration

Calyx RIM 6.2 CHF 5 provides:
  • The ability to identify – and then export the results to .xls - historical audit trail data for any value in Data Administration, including when and by whom values were added. For SPOR Maintenance values, the audit trail will reflect in addition whether the values were updated from the EMA or manually by a Data Administration user.
  • The ability to use filter functionality for Data Administration Values. See: Filters for Data Administration Values
  • The ability to see the full field value when you create or modify the pick list.
  • The ability to simultaneously update a MedDRA Version for multiple indications/intended use values.
  • The new System Process Default Flag supports the ability to assign several display statuses to the same Internal System Status in Data Administration for:
    • Application Status Values
    • Event-Change Detail Status Values
    • Product Status Values
    • Product Detail Set Status Values
    • Sequence Status Values
    When the status of an Application, Product, Product Detail Set, Event-Change Detail, and Sequence is updated as a result of running a status wizard or manually closing an event, the status set as the System Process Default is used. Prior to this update, the system would randomly pick a display status to show as the status when multiple display statuses were set to the same internal system status.

Global Project Plan Wizard

Extra fields can be updated in bulk on the Event Change Detail when the Details are associated to the Event via the Project > Associate Change Detail(s) to Events wizard. For details, please contact your Business Development Representative to consult with our Client Enablement team.

XEVMPD Acknowledgement Wizard

Calyx RIM 6.2 CHF 5 enables you to automate the inactivation of registration attachments when the corresponding acknowledgment is received via the XEVMPD Acknowledgement wizard. This option can be configured through application setup. By default, this option is disabled. These updates do not appear in the XEVMPD Audit Report.

XEVMPD Audit Report

To make the XEVMPD Audit Report more concise and efficient, the following inconsequential results are removed from the report:
  • Automated updates when an EV Code or the Validity Declaration is assigned
  • MedDRA Code and MedDRA Version when changes are made to them
  • Rows added for each country when an indication is added or modified for EU CP
  • Updates performed by SYSMAINT user

CT Shared Data

In prior versions of Calyx RIM for Registrations, on the Product Family > CT Shared window, the Protocol Number and EudraCT Number field had to be a unique combination. In Calyx RIM 6.2 CHF 5, the uniqueness rule is modified and only the Protocol Number must be unique within the Product Family.

Full Product Presentation

In Calyx RIM for Registrations, the Full Product Presentation (FPP) window displays a new field, XEVMPD Submission Required?, which enables you to categorize the FPPs ready for XEVMPD submission. You can trigger a system notification when the value of the new field changes.

Queries

The new List of Events with Change Details query enables you to view events that are associated with change, change details, and event change details.

Assemblies

In an assembly, you can now update the Folder or Leaf extension value from the Change Type > Extension without switching to Default value.

eCTD Import

Calyx RIM now retains the site folders in M5 after importing the study reports as node extensions.

Mass Update Properties

Clients with Electronic Lifecycle Publishing (ELP) licenses can use Mass Update Properties functionality.

Job Requests

In the Calyx RIM Publisher, new job statuses are introduced in the Job Request screen:
  • Completed with Errors
  • Completed with Warnings

Font Optimization in Paper Output

The new option Optimize Fonts in Paper Output minimizes font compatibility issues and provides stability to the process of printing paper output.

Optimized Memory Usage

Memory usage is optimized when publishing very large submissions in Calyx RIM 6.2 CHF 5.

Performance Improvements

Performance is improved for:

  • Add Submission to Lifecycle and Remove Submission from Lifecycle functionality.
  • Prepare to Publish with the options Remove Empty Assembly Folders and Remove Empty Assembly Leafs.
  • Updating Folder or Leaf extended attributes using Mass Update Properties functionality.