Calyx RIM Release Notes

List of Enhancements: Calyx RIM 7.0

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.

Calyx RIM: Common

Issue CHF/Hotfix Build Description
26698 6.2.0.6.0022 This change enables the selection of the EU National 3.0.3 template for the Great Britain and United Kingdom regulatory regions when using the Create eCTD Wizard.
26688 6.2.0.6.0022 The Application UUID is now unique within a regulatory region, instead of being unique within the system.
26682 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 6.2.0.6.0022 The UUID field is now visible on the application page for the countries of Great Britain and United Kingdom regions.
26674 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.
26644 6.2.0.6.0007 It is now possible to withdraw a country from Centralized Procedure (CP) applications via the Product Details Set. The withdrawn country is not available to associate with a subsequent Event (Countries list) created for the same Application.
26542 6.2.0.5.0055 For EAEU submissions, you can now auto-populate the Output Folder with metadata values from Solvent and Drug Substance extensions.
26541 6.2.0.5.0055 You can now include Solvent metadata for EAEU submission XML.
26519;

[PRB0040530]

6.2.0.5.0055 When diagnosing issues that required a restart, the data_exchanger.log and server.log files were cleared out after the restart. The configuration has been modified to prevent the log files from being cleared out after restart, and messages are continually added to the existing log files.
26512 6.2.0.5.0055 Mass Update Properties was available for Calyx RIM with the Submission Planning and Tracking (SPT) license, but not with the Electronic Lifecycle Publishing (ELP) license. Mass Update Properties functionality is now available for clients with ELP licenses.
26496;

[INC0025048]

6.2.0.5.0055 When creating a new working assembly using the Create eCTD wizard in an EU MRP application, the country metadata for the subsequent countries is copied as the default country metadata from the first country page except for the Agency name, Applicant, and Invented Name values even if a new country was added to the application.
26480;

[INC0023770]

6.2.0.5.0055 In Data Administration > Other Maintenance > Indications/Intended Use Values, you can use the Mass Update feature to update a MedDRA Version for multiple Indication/Intended Use values.
26450;

[CS0092205]

6.2.0.5.0055 Memory usage is optimized when publishing very large submissions in Calyx RIM.
26437 6.2.0.4.0079 To prevent instances when Calyx RIM could freeze due to an unstable connection to the Veeva DMS, the following timeout values have been added to the insight.var file for connections to the Veeva DMS:
  • veeva.api.connect.timeout - The maximum number of milliseconds the application will wait when attempting to establish a connection to a Veeva vault.
  • veeva.api.read.timeout - The maximum number of milliseconds the application will wait for a response from Veeva after a connection has been established to a Veeva vault.
If these parameter values are not included in the insight.var file, the respective timeouts will be equal to 30 seconds (veeva.api.connect.timeout) and 60 seconds (veeva.api.read.timeout).
26421 6.2.0.4.0079 The updated 510k and PMA assembly templates are included in this release.
26416 6.2.0.5.0055 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.
26387 6.2.0.5.0055 The uniqueness constraint for the EudraCT Number on a protocol is removed. A study or the clinical trial shared data can now include a redundant EudraCT Number.
26380 6.2.0.4.0079 Job Request messages include these updates:
  • The Job Message text is formatted with line breaks.
  • Errors displayed in the Job Message column are presented in bold text.
  • The descriptions of rendering errors are presented in bold text.
  • The Backbone Generator text that starts with ERROR: is presented in bold text, starting from ERROR: up to the line break.
26360 6.2.0.4.0079 On the home page, you can choose to show or hide specific product families from the Product Family navigation tree.
26359 6.2.0.5.0055 You can automate the inactivation of registration attachments once the corresponding acknowledgment is received via the XEVMPD Acknowledgement wizard. This option can be configured through application setup. By default, the option is disabled. These updates will not appear in the XEVMPD Audit Report.
26356 6.2.0.5.0055 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.
26355 6.2.0.4.0079 On the Entity Audit Trail of the Administration tab, you can now query the following entities:
  • Change
  • Change Details
  • Event Change Details
26354 6.2.0.5.0055 The new System Process Default Flag provides the ability to assign multiple display statuses to the same Internal System Status in Data Administration for Application, Event-Change Detail, Product, Product Detail Set, and Sequence. You can now see the assigned status after running the wizard or when the Event is closed manually.
26353 6.2.0.4.0079 The Event-Change Detail associations logic is changed. Now, the logic is based on the individual Event-Change Detail Status. If there are multiple Change Details associated with one Event and one of the Change Details has a status of Not Approved or Withdrawn, it will be available for selection even if the overall Event is closed as Approved.
26348 6.2.0.4.0079 The number of Veeva API calls has been significantly reduced for Expand Tree, Assign Binder, and Assign Document actions in DMS Browse/Search.
26345;

[INC0014459]

6.2.0.4.0079 The performance of the XEVMPD Submission wizard is improved.
26321;

[INC0013546]

6.2.0.5.0055 It is now possible to create a folder or a leaf with an extension other than Default and extended attributes populated using a single API call.
26315, 24020, 22557;

[00063191, 00041781, 00053012]

6.2.0.4.0079 When assigning documents from DMS, the leaf name and the output file name used for documents required revisions. It is now possible to define customized leaf and document attributes in the propertyMappings.xml file and use them when documents are assigned from DMS or File Share.
26314;

[00064910]

6.2.0.4.0079 The ability to create, update, activate, or deactivate Package Category and Package Type values in Data Administration using the API is added.
26289;

[INC0012144]

6.2.0.4.0079 Assigning Veeva sections caused the API burst limit to be exceeded. The number of Veeva API calls for assigning the Veeva document sections has been significantly reduced.
26265 6.2.0.5.0055 You can identify when any SPOR Maintenance value was created and by whom. These fields are added:
  • Created By
  • Created Date
26264 6.2.0.5.0055 You can identify when any Data Administration value was created/last modified and by whom. These fields are added:
  • Last User Updated
  • Last Changed Date
26204;

[00064468]

6.2.0.5.0055 The full field value can be viewed in Data Administration when you create or modify the pick list.
26200;

[00064469]

6.2.0.4.0079 The RMS Term Name field now appears as a column in the grid view for these Data Administration tables:
  • ATC Values .
  • Compendial Designation/Source Values.
  • Concentration Measure Type Values.
  • Country Values.
  • Denominator Unit Values.
  • Numerator Unit Values.
  • Dosage/Pharmaceutical Form Values.
  • EMA Authorisation Status Values.
  • Language Values.
  • Legal Basis  Values.
  • Medical Device Values.
  • Medicinal Product Type Values .
  • Procedure Type Values
  • Route of Administration Values
  • Unit of Measure Prefix Values
26181;

[00063727]

6.2.0.4.0079 Calyx RIM 7.0 enables you to configure a field of comma-separated values for use as search criteria in DMS Search, for Documentum only. This configuration can be applied to most of the text-like document attributes for Documentum. Please contact your Business Development Representative to consult with our Client Enablement team.
26158;

[00064073]

6.2.0.4.0079 The Calyx RIM API authentication process is enhanced to incorporate the LDAP configuration parameters defined in the insight.var file.
26136;

[00063706]

N/A The List of Events with Change Details report is introduced to support querying of Change/Change Detail/Event Change Detail entities with extra fields. Also, the Entity Audit Trail report now supports querying of Change/Change Detail/Event Change Detail.
26099;

[00063341]

6.2.0.4.0079 When a new working assembly is created under an application that includes unlifecycled assemblies, the warning message: "An unlifecycled working Assembly already exists for this Application under the following sequences:" shows the sequence codes for the working assemblies (with hyperlinks).
26081;

[00063116]

6.2.0.4.0079 Calyx RIM 7.0 supports the International Medical Device Regulators Forum (IMDRF) assembly templates for Health Canada.
25991, 24795, 23817;

[00060791, 00060643, 00047556, 00039935]

6.2.0.4.0079 When working with Study Tagging Files (STF), generic updates to extensions and extension attributes had to be made for each STF individually. It is now possible to update extensions or extension attributes for STFs in bulk using the Mass Update Properties feature.
25963

[00060633, 00054727]

7.0.0.0.0100 The Calyx RIM error messages are revised to make them accurate and easy to follow.

When Calyx RIM displays an error, you can go to the server.log file to get more details.

25954;

[00060145]

6.2.0.4.0079 In the XEVMPD Submission wizard, the Authorised Product section error messages have been revised for clarity. See: XEVMPD Error Messages for Authorised Product in the online help.
25795;

[00058695]

6.2.0.4.0079 To improve the user experience, the XML Definitions field is added to the Publish Request window.
24532, 20873;

[00044627, 00037898]

6.2.0.5.0055 New job statuses are introduced for Job Requests:
  • Completed with Errors
  • Completed with Warnings
24325 6.2.0.5.0055 Calyx RIM now retains the site folders in M5 after importing the study reports as node extensions.
24222

[00041913]

7.0.0.0.0100 In the Publish Request window, the Selected Leaf Elements option is now selected by default for the Publish eCTD/Electronic section.
23946, 23842;

[00039378, 00039725]

6.2.0.4.0079 When modifying the metadata (for example, 2.3.S, 2.3.P, Node Extension) in an assembly, each node had to be revised and updated individually. With the Mass Update Properties feature you can revise and update the metadata revisions in bulk.
23632;

[00038044]

N/A The option Update the sub-folder structure for 5.3.5 Reports of Efficacy and Safety Studies is now included in the Create Study Report wizard, to add study reports to specific Indication folders.
23803

[00039687]

6.2.0.5.0055 In an assembly, you can now update the Folder or Leaf extension value from the Change Type > Extension without switching to the Default value.
22824; [00030514, 00043876, INC0013821] 6.2.0.4.0079 When assigning multiple documents from DMS or a File Share, leafs were created with the name of the file along with the file extensions. It is now possible to define leaf and document attributes without extensions in the propertyMappings.xml file and use them when documents are assigned from DMS or a File Share.
22581;

[00026219]

6.2.0.4.0079 When assigning documents, if the leaf title field was blank, the value for it was not retrieved from a DMS. It is now possible to define a leaf title value that is taken from a source document in the propertyMappings.xml file.
20209

[131037FW, 00041581]

7.0.0.0.0100 You can now delete more than one Volume at a time from an Assembly using the Ctrl or Shift key.
20108;

[129625FW]

7.0.0.0.0100 To improve the user experience, the Publish Request window now shows only the required fields that are related to the selected Publishing Output Channel. You can now view/select all the Publishing Output Channel settings without scrolling.

Rendering

Issue CHF/Hotfix build Description
4977 4.4 CHF 2 A new method of Retrieve request and two new methods of backbone-generator request are introduced with this release to support:
  • eCTD import of EAEU submissions with PDFs embedded into XML
  • the process of EAEU submissions generation with PDFs embedded into XML