List of Enhancements: Calyx RIM 6.2

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 6.2

Calyx RIM  6.2 includes the following enhancements.

Issue Description
25698;

[00057639]

Calyx RIM 6.2 enhances the XEVMPD Submission wizard to take the prior approved PDS Detail from the previous Event into the XEVMPD Submission if the current PDS Detail has one of the following statuses:
  • Pending Modify
  • Pending Withdrawal
This enhancement is applicable to the following PDS Details:
  • Active Ingredient (including the Reference Active Ingredient logic)
  • Indication/Indented Use
  • Indication (under Veterinary Product Family)
  • Strain
  • Reference Strain
  • Substance (Excipient, Adjuvant, and Substance entities used as Active Ingredient)
The PDS Details with status set to Withdrawn are not:
  • Included into XEVMPD Submission
  • Displayed in the XEVMPD Audit Analytics report
25680;

[00056846]

Calyx RIM 6.2 updates the uniqueness rule for the Full Product Presentation entity to have the concatenation of the following fields unique within the Registration:

Full Product Name, EEA Country, Language, Package Description, Authorisation Status, Authorisation/Renewal Date, and EV Code.

25675;

[00057202, 00057471, 00057946, 00058223]

Calyx RIM 6.2 introduces support of the ICH STF Stylesheet v2.3. The following updates have been applied:
  • When you select the stf-2-2 in the XML Definitions field, the published output will contain the new version of the Stylesheet file: util\style\ich-stf-stylesheet-2-3.xsl
  • When you select the stf-2-2-3-0 in the XML Definitions field, the published output will contain the new version of the Stylesheet file: util\style\ich-stf-stylesheet-2-3.xsl
Note: The MD5 checksum of the STF stylesheet is: 92BFEB4CB358A4AF786317A0DA2309C5
25663 Calyx RIM 6.2 provides support for Australia eCTD Module 1 Specification Version 3.1 and AU NeeS v2.0 specification.
25662;

[00057090, 00057174]

Calyx RIM 6.2 supports EU eCTD Module 1 Specification Version 3.0.3. The EU eCTD Module 1 Templates have been updated.
Note: See Clarification of Behavior: Calyx RIM 6.2.
25607;

[00056665]

With Calyx RIM 6.2, it is now possible to associate a Package Set to a Registration via workflow.
25563 With Calyx RIM 6.2, a new configured field named Local Route of Administration has been added to the PDS Attributes page for tracking country Route of Administration on PDS level. This field is hidden by default and can be enabled via the overrides.

In addition, if configured to be available, the Local Route of Administration field is displayed in the XEVMPD Audit Report under the Pharmaceutical Product-Administration Route XEVMPD Entity.

25575;

[00056237]

With Calyx RIM 6.2, a new validation has been added to the XEVMPD Submission wizard invoked for the Authorised Product flow. When the MFL (Master File Location) value is not selected for a Registration being submitted, a warning message appears indicating that the MFL is required for this operation type.
Note: The MFL value is mandatory for Insert, Update and Invalidate MA operation types.

To be able to proceed with the wizard and have the MFL tag included to the submission XML file, the MFL value on the Registration Attributes page must be defined.

25533 The AssemblyImport.xsd file included in the Calyx RIM 6.2 release along with the corresponding Assembly XML Specification set topics located in the Calyx RIM Administration guide have been provided to aid in the creation of the Assembly XML file from scratch using third-party tools, or leveraging it from an exported Assembly.
25527 With Calyx RIM 6.2, the following enhancements have been introduced to support the Legal Basis field to be available for the Package Set Registration entity and be included to the XEVMPD Submission XML file:
  • A new drop-down list named Legal Basis has been added to the Registration of a Package Set type.
  • The Legal Basis Values table has been removed from the Data Administration > Application Maintenance section and is now included under the Data Administration > Other section.
  • The Registration Attributes > Entity History Query and Querying > Administration > Entity Audit Trail queries have been updated to display the correct values for the new Legal Basis field.
  • The Registration > Legal Basis value is included to the XEVMPD Submission XML file instead of the Application > Legal Basis value, if:
    • The field is populated with a value for both entities.
    • The Application > Legal Basis field is not populated with a value
25521;

[00055762]

This enhancement introduces the ability to have a workflow that allows for updating of Active Ingredient, Reference Active Ingredient, and Pharmaceutical Product entity specific data.
25435 With Calyx RIM 6.2, the Initial Report option has been hidden in the XEVMPD Submission wizard:
  • The Run Initial Report? drop-down has been hidden on the Select Sender/Receiver Information page.
  • The Initial Report Selection and Initial Report Selection Results pages that appeared when the Run Initial Report? drop-down field was set to Yes, has been hidden in the wizard.
25430;

[00054572]

With Calyx RIM 6.2, the PLANNED status has been added to the:
  • Project Pivot Status drop-down field on the Create/Modify Projest Attributes page.
  • Enter Project Pivot Values > Project Pivot Status drop-down field of the Calculate Projected Dates wizard (Global Project Plan wizard).

In addition, the PLANNED internal event status has been added. By default, the internal Event Status PLANNED is mapped to the Planned Event Status.

25416 To make the Excipient Role field available for all substance types in the Product Detail Set and Product Detail Set Template, the Data Administration > Product Detail Set Maintenance > Excipient Role Values table is renamed as Substance Role Values, and the Excipient Role field for the Substance Detail is renamed as Substance Role. The Substance Role field appears on the Add Substance page regardless of the selected Substance Type value.
25407 Using XML overrides, Calyx RIM 6.2 can be configured to disable the autopopulate function for one or more Registration Attachment fields, if the Attachment file is uploaded from a DMS Repository:
  • Attachment Name
  • File Name
  • File Type
  • Attachment Version
25387;

[00054264]

Calyx RIM 6.2 enhances the XEVMPD submission data collection features. Although the Package Set information is not included in the XEVMPD submission, the Package Set assigned to the Full Product Presentation will determine the Active Ingredient, Substance, Indication/Intended Use (non-Veterinary), or Species Indication (Veterinary) PDS Details to be included. Only those PDS Details, with Package Set from the parent PDS associated to the Full Product Presentation, are included in the XEVMPD submission.
25373;

[00053960]

Starting with Calyx RIM 6.2, the Application Status of an Application can be set to Withdrawn only when all Registrations associated to the Application have a status mapped to internal WITHDRAWN status.
25372 With Calyx RIM 6.2, the Attachment Name field on the Create Registration FPP Attachment page has been reworked to be a Registration Attachment Selection list. The selected Registration Attachment is displayed in the Attachment Name > Selected box in the concatenation of four fields: Internal Name, Attachment Language, Attachment Name, Attachment Version.
25367 Calyx RIM 6.2 enhances the Entity Audit Trail Administration Query to add support for the CT Shared Data. The CT Shared Data option is added to the Entity Type multi-select list.
25341;

[00053767]

Calyx RIM 6.2 provides updates to the Indication/Intended Use detail in the Non-Veterinary Product Details Set (PDS) and Species Indication detail in the Veterinary Product Detail Set (PDS). All countries of the associated Application by default appear in the Selected box of the Countries field on the Add Indication/Intended Use detail (Non-Veterinary PDS) and Add Indication detail (Veterinary PDS) pages. You can deselect countries, if needed.
25340;

[00053739]

With Calyx RIM 6.2, the mrpnumber generated by the XEVMPD Submission wizard is displayed without a space between Procedure Identifier/Application Code and Speciality Number. For example: [Procedure Identifier/Application Code][Speciality Number1]. As an addition to this enhancement, the Specialty Number field has been renamed to be Speciality Number.
25335;

[00053740]

To enable the Previous EV Code value for the Full Product Presentation entity to be added manually, Calyx RIM 6.2 provides the following enhancements:
  • The Authorised Product option has been hidden from the Data Administration > Other > Previous EV Code Values > Code Type drop-down list.
  • The Full Product Presentation > Previous EV Code drop-down list has been reworked to be the FPP Previous EV Codes tab on the Full Product Presentation Attributes page. If there are several Previous EV Code values, in the XEVMPD XML file that results in several <previousevcode> tags.
25329, 24993;

[00053680, 00049980]

Calyx RIM 6.2 enhances Data Exchange by adding the User Authentication, Authorisation, and Auditing support.
  • Data Exchange can be configured to enforce user authentication for each incoming request.
  • Data Exchange can be configured to enforce authorisation to specific user accounts.
  • Authentication and authorisation logging has been added in the following categories:
    • com.liquent.insight.dataexchanger
    • com.liquent.insight.messaging.jms

The Data Exchange XML schema contains the additional attributes named user and password on the root <dataexchange> tag. This is used to pass the credentials of the user to authenticate and use during the Data Exchange transaction.

For example: <dataexchange user=”de_user” password=”de_password”>

Important: These attributes are only required if Data Exchange authentication is configured to be used.
25284; Calyx RIM 6.2 provides support for the following Ricoh Pro Printers:
  • Ricoh Pro C5200s/C5210s
  • Ricoh Pro C5200s/C5210s, US Punch*
  • Ricoh Pro C5200s/C5210s, ISO Punch*
25280;

[00052554; 00054120]

Calyx RIM 6.2 enhances the logic for determining the Confirmed Sequence Code value in the Change Submittal Status wizard. The Confirmed Sequence Code value is determined based on the number of sequences that have been submitted to this application lifecycle, and now considers all previously submitted sequences, even if the current Sequence Status is set to Approved.
25273;

[00051853]

Calyx RIM 6.2 provides support for the following Web browsers:
  • Microsoft Internet Explorer (IE) 11 (set Compatibility View Settings to Off)
  • Microsoft Edge (supported on Windows 10 only)
  • Google Chrome
Note: Please note that Calyx RIM for Analytics module is not compatible with the Microsoft Edge browser.
25242 Calyx RIM 6.2 enables you to copy a Registration entity using the Copy Package Set Registration wizard. The wizard can be invoked for a Package Set Registration only. Two flows are available for selection in the Copy Package Set Registration wizard:
  • New Package Set specific Registration(s). This flow also allows you to copy the Full Product Presentations and Registration FPP Attachments, if any are assigned to the Registration you selected to copy, and the minimum required security settings are met.
  • New Product specific Registration(s).
25239;

[00055798]

Calyx RIM 6.2 enables you to copy a Full Product Presentation entity using the Copy Full Product Presentation wizard. Two flows are available for selection in the Copy Full Product Presentation wizard:
  • Full Product Presentation under different Registration(s)
  • Full Product Presentation under the same Registration
25218;

[00052214]

Calyx RIM 6.2 provides the ability to edit the Reference Leaf elements in the Unlocked Submitted View of a Sequence Assembly, if the following rules are met:
  • To modify a Reference Leaf element in the unlocked submitted assembly plan view, in Security Administration you must have the Entity Security > Submission Plans set to at least WRITE and Entity Security > Sequence Assemblies set to ADMIN.
  • To modify a Reference Leaf element in the unlocked submitted assembly view, in Security Administration you must have the Application Country Rights set to at least WRITE and Entity Security > Sequence Assemblies set to ADMIN.
25179 Calyx RIM 6.2 enhances the XEVMPD Audit Analytics Predefined Report to include an additional filter named Message Sender. An additional column named Message Sender has been added to the XEVMPD Audit Analytics Predefined Report results page.
25169;

[00051802]

Calyx RIM 6.2 enhances the Create Submission Wizard > Initial Application flow. The Event Type field on the Complete Submission Properties (event/sequence) page is now available for modifications. The drop-down field displays all Active values from Data Administration > Event Maintenance > Event Type Values.
25163;

[00047861]

The maximum number of users that can access Calyx RIM for Analytics Reports has been increased from 1280 to 5000.
25159;

[00051747]

Calyx RIM 6.2 enhances the List of Applications with Products query, in the Registrations Planning and Tracking section, to provide the ability to search for all application types available in the system. All application types are now displayed and available for selection in the Application Type multi-select list.
25083;

[00050940]

To provide the ability to identify the association between the parent Task and its Sub-Task, Calyx RIM 6.2 enhances the Task entity by adding a new field named Related Task Name. When a Task has an associated Sub-Task entity, the Related Task Name field for the Sub-Task will be populated automatically with the parent Task Name value. This field will always be empty for the parent Task entity.
To support this enhancement, the following Registration Planning and Tracking reports have been updated with a new filter field named Related Task Name (enter parent Task/Sub-Task name if any):
  • List of Tasks
  • List of Tasks - Rollup by Product Family
  • List of Tasks - Rollup by Application
  • List of Tasks - Rollup by Project
The following changes are introduced to support this enhancement:
  • The listed Registration Planning and Tracking reports have been updated to add a new column named Related Task Name to the Search Results page. The value in the column is hyperlinked. When selected, this displays the appropriate Task Attributes page.
  • The Related Task Name column has been added to the Querying > Administration > Entity Audit Trail > Query table when querying for the Task entity. The value is not hyperlinked.
  • The Related Task Name column has been added to the Search Results page of the SEARCH functionality when invoked for the Tasks/Sub-tasks option. The value in the column is hyperlinked. When selected, this displays the appropriate Task Attributes page.
25055 Calyx RIM Data Exchange now provides the ability to import Region Values records into the Calyx RIM database.
24743;

[00047073]

Calyx RIM 6.2 enhances the Global Project Plan wizard by adding the multi-select field Application Type as an additional filter criterion for the following project types:
  • Create New Events Package Set Registration > Search by Product, Country and Application Status page
  • Update Product Detail Sets > Input Query Filter Criteria page, when searching by:
    • Active Ingredient
    • PDS Code/PDS Name
    • Product and Country
    • Substance
    • Trade Name
  • Create New Events Product Registration > Search Country and Application Status page
  • Withdraw Product Package Set Registration > Search by Product, Country Application and PDS Statuses page
24742;

[00047074]

Calyx RIM 6.2 enables a Sequence to be updated in bulk within a project. The Project Attributes page has been enhanced by adding the Bulk Update Sequences icon that launches the Bulk Update Sequences wizard.
24711;

[00046629]

To enable the Manufacturer Name value to be displayed as a concatenation of Manufacturer Name + Address Line 1 + Country Code values in the Manufacturer field for each Product Detail Set > Manufacturer Detail instance, Calyx RIM 6.2 introduces the following enhancements to the Data Administration > Product Detail Set Maintenance > Manufacturer Values > Manufacturer value attributes page:
  • The Country text field has been reworked to be a drop-down list with all active Country values from the Data Administration > Country Values table available for selection.
  • The Country Code drop-down list is no longer presented on the Create/Modify Manufacturer attributes page.
In addition to all instances of Manufacturer Detail in the Product Detail Set, to support this enhancement the Manufacturer Name value concatenation is now displayed for the following areas:
  • Queries > Product Detail Management:
    • Application History Query
    • Application QC Status History Report
    • List of Active Ingredient Manufacturers
    • List of Active Ingredient Function Manufacturers
    • List of Active Ingredient Material Manufacturers
    • List of Excipient Manufacturers
    • List of PDS Manufacturers
    • List of Component Manufacturers
    • List of Package Set Manufacturers
  • Queries > Administration:
    • Entity Audit Trail
  • Global Project Plan wizard:
    • Add Active Ingredient Manufacturer flow
    • Add Active Ingredient Manufacturing Process Function Manufacturer flow
    • Add Substance Manufacturer flow
    • Add Substance Manufacturing Process Function Manufacturer flow
    • Add Component Function Manufacturer flow
    • Add Component Manufacturing Process Function Manufacturer flow
    • Add PDS Function Manufacturer flow
    • Add PDS Manufacturing Process Function Manufacturer flow
    • Add Package Set Function Manufacturer flow
    • Add Package Set Packaging Manufacturer flow
    • Add Package Set Component Packaging Manufacturer flow
  • Comparator > Suppliers multi-select list
23671;

[00038325]

The Analytics schema has been updated to include the audit trail information stored within Calyx RIM, enabling users to create reports and metrics against the audit information, using Calyx RIM for Analytics.
23634;

[00038044]

With Calyx RIM 6.2 you are now able to:
  • Select a bunch of different Assembly Tree nodes using the Ctrl or Shift keys, invoke the context menu and delete the selected items in a bulk;
  • Select several different Assembly Tree nodes the Ctrl or Shift keys and drag-and-drop them on the valid node.
23580;

[00037237]

Calyx RIM 6.2 enhances the following Product Strength-related fields to display a leading zero value for the decimal numbers that are less than 1 in the Product Strength field on the View Product Attributes page:
  • Product Strength Measure 1
  • Product Strength Measure 2
Calyx RIM 6.2 enhances the business rules for the Product Strength Measure 1 and Product Strength Measure 2 fields. The entered value must not exceed 5 decimal numbers before the decimal point and 5 decimal numbers after the decimal point.
Note: The value cannot be larger than 99999.99999.
23432, 22641, 20705;

[00028353, 00029094]

When modifying a TOC tree, it is now possible to select multiple nodes and drag them in between the other nodes.
22788, 15649;

[00029856, 75107FW, 115454FW]

With the New Version of the Assembly Tree introduced in Calyx RIM 6.2, it is now possible to select and delete multiple Assembly Tree nodes simultaneously using the Ctrl or Shift keys.
22207;

[00209161, 00042932]

Delete (Withdraw) lifecycle operation is now available in the right-click menu for multiple selected leafs.
21791;

[00038699]

Calyx RIM 6.2 enhances the Event entity by renaming the Event Closed As field as Associations Closed As and the Event Closed Date field as Closed Date.
21788;

[000175882]

The performance of the List of Sequences with Application and Event Properties query has been improved in Calyx RIM 6.2.
20557;

[000139077]

With Calyx RIM 6.2 release, using the Assembly Tree Filter functionality you can now search for a specific study folder in Module 4 and Module 5 using the value of the Report Number attribute.
16620;

[00076590FW, 00083511FW, 000133431FW, 000142150FW, 00039250]

With Calyx RIM 6.2, it is possible to delete the first and last elements in either locked or unlocked volumes. After the element is deleted from the volume range, the Volume structure will be adjusted automatically.
14129;

[00036861]

With Calyx RIM 6.2 release, the inactive or disabled users are omitted from the lists of available values (username, or username (email address) combination) for the following Task entity fields:
  • Assigner drop-down list
  • Premier Assignee drop-down list
  • Task Concerned Parties popup window
10376 Using the Search function on the menu bar, it is now possible to find sequences quickly.

See New in Calyx RIM 6.2, Entity Fields Added: Calyx RIM 6.2, Entity Fields Updated: Calyx RIM 6.2, Query Fields Added: Calyx RIM 6.2, Query Fields Updated: Calyx RIM 6.2, and Data Administration Tables: Calyx RIM 6.2.