Calyx RIM 6.2 Release Notes

New in Calyx RIM 6.2

Calyx RIM 6.2 includes enhancements and also addresses prioritized hotfixes and known issues from previous versions. The following enhancements, functional changes, and updates are included with this release.

Web Browsers

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.

Single Sign On (SSO)

Calyx RIM single sign on (SSO) will enable authorized users who are authenticated by your enterprise's SSO the capability to access LIQUENT InSight without the need to login again.

Calyx RIM API

LIQUENT InSight 6.2 provides an application programming interface (API) for integration with external systems. The Calyx RIM API enables external systems to access data within LIQUENT InSight and to perform actions such as create, read, update, and delete. New platform components can integrate with the LIQUENT InSight API, and will observe authentication and authorisation rules.

New Assembly Tree

Calyx RIM 6.2 completes the transition to the new version of the assembly tree introduced in Calyx RIM 6.1 CHF 3. The legacy assembly tree option is no longer available.

This release also discontinues support of the drag-and-drop node assignments between assemblies opened in separate browser windows. The Import Assembly wizard should be used to copy content between different assemblies.

The new assembly tree enables the following functionality:

  • Drag assembly elements to in-between nodes and filter the assembly tree elements using the new assembly tree search option.
  • Set a limit to the number of assembly elements displayed on the new version of the assembly tree as a result of a search operation.
  • Set a limit to the number of nodes that can be expanded in the new version of the assembly tree.
  • Drag a TOC onto the icon corresponding to a volume.
  • Calyx RIM 6.2 enhances the TOC tree to allow selecting multiple nodes and dragging them in between the other nodes when modifying a TOC.

Cross-site Scripting (XSS) Filtering

Calyx RIM 6.2 includes Cross-site Scripting (XSS) filtering that prevents users from adding malicious script codes in the form of user input in an attempt to access data.

Performance Improvements

Calyx RIM 6.2 provides performance improvements for the following:
  • Manufacturer Report Analytics Predefined Report functionality.
  • XEVMPD Audit Report functionality.
  • DMS Synchronization functionality invoked from the Publishing View of the Assembly.
  • Updating the Publishing Settings to add or remove a DTD.
  • Expanding the nodes in the Assembly Tree and refreshing the expanded Assembly Tree.
  • Queries related to getting Events under Application, actions with the XEVMPD change history, and DTD change for an Assembly have been optimized to reduce the possibility of database locks. As part of this optimization, a new index has been added to the XEVMPD change history.

OpenText Documentum D2 Integration

Calyx RIM 6.2 enhances the capability to harmonize data between Calyx RIM and OpenText Documentum D2:
  • When a Product Family is created in Calyx RIM, both a Product Registration Form and a Project Registration Form will be created within Documentum D2.
  • When an Application is created under a Product Family in Calyx RIM, a Regulatory Application Registration Form (RARF) will be created within Documentum D2.
  • When a Sequence is created within a Product Family in Calyx RIM, a Submission Registration Form (SARF) will be created within Documentum D2.
Note: The Product Registration Form, Project Registration Form, RARF, and SARF are created only if the Product Family type is one of the following:
  • Pharmaceutical
  • Pharmaceutical-Medical Device
  • Any custom Product Family type that is mapped to the Pharmaceutical or Pharmaceutical-Medical Device internal type
  • Any Product Family type in Data Administration that is modified and mapped to any of the Pharmaceutical or Pharmaceutical-Medical Device internal type

The created Product Registration Form, Project Registration Form, Regulatory Application Registration Form, and Submission Registration Form will then be updated according to the changes made to Product Family within Calyx RIM.

Updates to D2 forms (Product Registration Form, Project Registration Form, Regulatory Application Registration Form, and Submission Registration Form) may result in updates to the PDS status. Allowed PDS Status values include:
  • Pending Add
  • Approved
  • Not Approved

The out-of-the-box configuration can be modified to match your need. To understand more about the available Documentum D2 mapping for Product Registration Forms, Project Registration Forms, Regulatory Application Registration Forms (RARF), Submission Registration Forms (SRF), please contact your Calyx RIM account representative.

D2 Data Dictionaries

Starting with Calyx RIM 6.2, the following D2 Data Dictionaries are supported:
  • Application Status
  • Application Type
  • Geographic Regions
  • Regulatory Submission Type
  • Route of Administration List
  • Submission Country
  • Submission Status
  • Dosage Levels
  • Dosage Forms
  • Health Authority

Regulatory Updates

Australia eCTD Module 1 Specification Version 3.1

Calyx RIM 6.2 supports Australia eCTD Module 1 Specification Version 3.1. The following structural updates are provided with this Specification Version:
  • The following sections are added to the 1 Administration Information and Prescribing Information > 1.3 Medicine information and labeling folder:
    • 1.3.1.3 Product information - approved
    • 1.3.2.3 Consumer medicine information - approved
  • The following sections are updated in the 1 Administration Information and Prescribing Information > 1.3 Medicine information and labeling folder:
    • 1.3.1.3 Package Insert section now appears as 1.3.1.4 Package Insert
    • 1.3.3 Label mock-ups and specimens section is split to be 1.3.3.1 Label mock-ups and specimens - clean, 1.3.3.2 Label mock-ups and specimens - annotated, and 1.3.3.3 Label mock-ups and specimens approved
    • 1.5.2 Orphan designation section now appears as 1.5.2 Designation applications - supporting documents

Calyx RIM 6.2 also supports the AU NeeS v2.0 specification. This new NeeS version TGA (Therapeutic Goods Administration) introduces Envelope Form to provide greater validation of NeeS Submissions and automation of the uploading processes. The envelope form is an XML file with information from Envelope. The NeeS format dossier must contain tables of contents (TOC) in PDF format. The XML file should be included in the 1001-cover folder of the NeeS application and it should be referenced by the m1-toc.pdf.

Please note that the previous specifications versions will be acceptable for use until 30 June 2018.

This specification introduces the following updates to Data Administration:
  • New sequence types has been added to the Sequence Maintenance > Filing Type Values table:
    • Provisional Registration - TGA initiated variation
    • Notification
    • CN
    • Extension of Provisional Registration
    • Duplicate
  • The following sequence type has been updated in the Sequence Maintenance > Filing Type Values table:
    • Withdrawal filing type has been updated to be Product Withdrawal.
  • New Sequence Description value has been added to the Submission Maintenance > Sequence Description Values table:
    • Provisional approval - rolling data submission - {date: d}
  • New Regulatory Activity Lead value has been added to the Submission Maintenance > Regulatory Activity Lead Values table:
    • Prescription meds-biological

European Union eCTD Module 1 Specification Version 3.0.3

Calyx RIM 6.2 supports EU eCTD Module 1 Specification Version 3.0.3.

The EU eCTD Module 1 Specification has been updated to reflect clarifications of the 3.0.1 version in the 3.0.3 version. Version 3.0.3 is in force immediately and is recommended to be used as soon possible. There are no changes to the DTD in this version (version 3.0.1 is still valid) and the validation criterion has not changed as a result of this update.

The following updates are introduced:
  • For the Centralised (CP) template, in the 1.2 Application Form > 1.2 EMA folder:
    • The Application Form leaf has been renamed to be Application Form Annex (the Use Native File parameter is set to No).
    • A new leaf has been added Application Form eAF (the Use Native File parameter is set to Yes).
  • For the National (NP) and Mutual Recognition (MRP)/Decentralised (DCP) templates in the 1.2 Application Form > Country folder:
    • The Application Form leaf has been renamed to be Application Form Annex (the Use Native File parameter is set to No).
    • A new leaf has been added Application Form eAF (the Use Native File parameter is set to Yes).

STF Stylesheet v2.3 Support

Calyx RIM 6.2 introduces support for the ICH STF Stylesheet v2.3.

Best Practices for Publishing

The following topics on best practices for publishing have been updated in the Online help:
  • Complying with the Study Data Technical Conformance Guide v4.1
  • Updating an AU Submission to Migrate to v3.1

Withdraw Country Updates

Calyx RIM 6.2 updates how withdrawn Application Countries are filtered in the Country fields of Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP) procedures. On application-related entities, withdrawn application countries that have a Withdraw Date value that equals today’s date or earlier can no longer be selected for the following:
  • Event > Countries field when adding an Event
  • Sequence > Concerned Member States field when adding a Sequence
  • Registration > Country field when adding a Registration
  • Product Detail Set > Label > Label Country field when adding a Label Detail
  • Product Detail Set > Country > Country field when adding a Country Detail
  • Product Detail Set > Indication/Intended Use > Countries field when adding or modifying an Indication/Intended Use Detail (non-Veterinary Product Detail Sets)
  • Product Detail Set > Species Indication > Countries field when adding or modifying an Indication Use Detail (for Veterinary Product Detail Sets)
  • Product Detail Set > Manufacturer > Countries field when adding or modifying a Manufacturer for the following parent Product Detail Set Details:
    • Active Ingredient
    • Active Ingredient Manufacturing Process Function
    • Active Ingredient Manufacturing Process Step Function
    • Active Ingredient Manufacturing Process Step Material
    • Component Function
    • Component Manufacturing Process Function
    • Component Manufacturing Process Step Function
    • Component Manufacturing Process Step Material
    • Package Set Component Packaging
    • Package Set Function
    • Package Set Packaging
    • Product Detail Set Function
    • Product Detail Set Manufacturing Process Function
    • Product Detail Set Manufacturing Process Step Function
    • Product Detail Set Manufacturing Process Step Material
    • Substance
    • Substance Manufacturing Process Function
    • Substance Manufacturing Process Step Function
    • Substance Manufacturing Process Step Material

The Countries tab on the Application Attributes page has been enhanced by adding a new column named Withdraw Date.

The logic of populating the Withdraw Date for an Application Country has changed. The following rules apply to the Application Country > Withdraw Date if this specific country is associated to the Country PDS Detail:
  • If the Country Status field of the related Country PDS Detail is modified to Approved, the Application Country > Withdraw Date field is automatically updated to be equal to Today's Date.
  • If the Event is closed as Approved, meaning it has the Associations Closed As field set to APPROVED, the Application Country > Withdrawn Date field is automatically updated to be equal to Event Closed Date value. As an additional rule, the withdrawn Country PDS Detail > Country Status field is automatically updated to Approved. See If the Event Is Closed with the Status Approved.
    Note: The Update Status and Update Event Country Status wizards, launched from the Event > Countries tab and Project > Event Country Dates tab, has been updated accordingly. The following new messages have been added:
    • Confirmation page: The Withdraw Date will be set to <Event Closed As Date> for <Country that is being withdrawn>.
    • Summary page: The Withdraw Date was set to <Event Closed As Date> for <Country that is being withdrawn>.

This enhancement updates a variety of existing queries and adds a new Product Detail Management query named List of Application Countries with PDS Country and Registration Details. See the Queries section.

See Entity Fields Updated: Calyx RIM 6.2 and Entity Fields Added: Calyx RIM 6.2.

Global Project Plan Wizard

Calyx RIM 6.2 enhances the Global Project Plan (GPP) wizard by adding new process flows:
  • Add Manufacturing Process
  • Add Manufacturing Process Step Function
  • Add Material
  • Add Substance
  • Modify Active Ingredient
  • Modify Manufacturing Process Step
  • Modify Manufacturing Process Step Function
  • Modify Material
  • Modify Packaging for Package Set
  • Modify Substance
  • Withdraw Material
  • Withdraw Substance
  • Replace Manufacturing Process Step Function
To support the enhancement to display the Manufacturer Name value as a concatenation of Manufacturer Name + Address Line 1 + Country Code values, the following Global Project Plan > Update Product Detail Sets project flows have been updated:
  • Add Active Ingredient Manufacturer
  • Add Active Ingredient Manufacturing Process Function Manufacturer
  • Add Substance Manufacturer flow
  • Add Substance Manufacturing Process Function Manufacturer
  • Add Component Function Manufacturer flow
  • Add Component Manufacturing Process Function Manufacturer
  • Add PDS Function Manufacturer flow
  • Add PDS Manufacturing Process Function Manufacturer
  • Add Package Set Function Manufacturer
  • Add Package Set Packaging Manufacturer
  • Add Package Set Component Packaging Manufacturer
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

Events

Calyx RIM 6.2 introduces new rules to enforce Event uniqueness within an Application. The Event Name and Event Code combination must be unique within an Application.

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. The following has been updated accordingly:
  • View Event Attributes page for the closed events.
  • Modify Event Attributes page, if the Closed checkbox is selected.
  • Wizards > Update Status > Update Event Country Status page, if the Close Event? drop-down field is set to Yes.
  • Project > Event Country Dates > Update Project Event Country Status wizard, if the Close Event? drop-down field is set to Yes.

This enhancement also provides a variety of updates to existing queries. See Queries section.

See Entity Fields Updated: Calyx RIM 6.2

Projects

Calyx RIM 6.2 enables Sequences 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.

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

Product Detail Sets (PDS)

Calyx RIM 6.2 enhances the Countries field on the Add Indication/Intended Use detail page for Non-Veterinary Product Detail Set (PDS) and the Add Indication detail page for Veterinary Product Detail Set (PDS). By default, all countries of the associated Application appear in the Selected box of the Countries multi-select field. You can deselect countries, if needed.

To enforce PDS uniqueness within an application, a PDS name must now be unique.

To enforce PDS template uniqueness within a product, a Product name must now be unique.

The Specialty Number field has been renamed to be Speciality Number.

To ensure the Excipient Role field availability for all substance types in the Product Detail Set and Product Detail Set Template, Calyx RIM 6.2 renames the Excipient Role field for the Substance Detail as Substance Role. The Substance Role field appears on the Add Substance page regardless of the selected Substance Type value.

Starting with Calyx RIM 6.2, the Manufacturer Name value is 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. This update includes enhancements to the following Calyx RIM areas:
  • Data Administration > Product Detail Set Maintenance > Manufacturer Values table
  • Product Detail Management, Registration Planning and Tracking, and Administration Queries
  • A variety of Global Project Plan Wizard > Update Product Detail Sets project flows
  • Comparator > Supplier field
A new configured field named Local Route of Administration for tracking country Route of Administration at the PDS level has been added to the PDS Attributes page.
Note: This field is hidden by default and can be enabled via custom XML overrides.

See the corresponding sections in the New in Calyx RIM 6.2, Entity Fields Updated: Calyx RIM 6.2, and Data Administration Tables: Calyx RIM 6.2.

Products

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

A new entity named Country Specific Detail has been introduced for the Products of Medical Device and Pharmaceutical Medical Device types.

See Entity Fields Added: Calyx RIM 6.2

Applications

Starting with Calyx RIM 6.2, the Application Status of an Application can be set to the Application Status mapped to the internal WITHDRAWN status only when all Registrations associated to this Application have a status mapped to the internal WITHDRAWN status.

The Update Status and Update Event-Country Status wizards mapped to the internal WITHDRAWN status reflect this enhancement. If you set Associations Closed As to WITHDRAWN, the Application Status will be set to WITHDRAWN only when all Registrations associated to this Application have a status mapped to the internal WITHDRAWN status. Otherwise, the warning message appears ! Associated Registration(s) must be Withdrawn prior to the Application.

See Entity Fields Updated: Calyx RIM 6.2

Registrations

In Calyx RIM 6.2, the logic of the Copy Package Set Registration wizard has been reworked for the MRP (Mutual Recognition Procedure) and DCP (Decentralised Procedure) Application types to provide the ability to select the country to copy the Package Set Registration. A new drop-down list named Country now appears on the following wizard pages for the MRP and DCP Application types:
  • New Package Set specific Registration(s) > Select Product Detail Set page
  • New Product specific Registration(s) > Copy License Code page
A new field named Legal Basis has been added to the Package Set Registration entity. 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. This update includes enhancements to the following Calyx RIM areas:
  • Data Administration > Application Maintenance and Data Administration > Other sections
  • XEVMPD Submission Wizard data collection logic

See the corresponding sections in the topics: New in Calyx RIM 6.2, Entity Fields Added: Calyx RIM 6.2, and Data Administration Tables: Calyx RIM 6.2.

Full Product Presentations

With Calyx RIM 6.2, the MPID (Medicinal Product Identifier) field has been hidden on the Full Product Presentation View, Create, and Modify pages.

Calyx RIM 6.2 enhances the Full Product Presentation Attributes entity by adding the following new fields:
  • Formulation Part
  • Intended Use Part
  • Target Population Part
  • Container or Pack Part
  • Device Part
  • Time Period Part
  • Flavour Part
  • Countries
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, this will result in several <previousevcode> tags being added to the XEVMPD XML file.

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.

See Entity Fields Added: Calyx RIM 6.2, and Data Administration Tables: Calyx RIM 6.2.

Registration FPP Attachments

With Calyx RIM 6.2, the Attachment Name field has been reworked to be a Registration Attachment Selection list on the Create Registration FPP Attachment page. Once selected, the search results page displays all Active Registration Attachments that are available in the system and are not associated to the current Full Product Presentation.

See Entity Fields Updated: Calyx RIM 6.2.

Registration Attachments

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

For details, please contact your Business Development Representative to consult with our Client Enablement team.

References

To enforce Reference uniqueness within its parent entity, a Reference name must be unique.

Tasks

To enforce Task uniqueness within its parent entity, a Task name must be unique.

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 automatically populated with the parent Task Name value. This field will always be empty for the parent Task entity.

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

See Entity Fields Added: Calyx RIM 6.2 and Query Fields Added: Calyx RIM 6.2.

Workflows

Calyx RIM 6.2 includes the following enhancements in the optional Calyx RIM Workflow Integration module to provide support for the XEVMPD entities:
  • This release provides the ability to configure a workflow XML file to create and update the following entities:
    • Active Ingredient
    • Component
    • FPP Previous EV Code
    • Full Product Presentation
    • PDS Details: Active Ingredient
    • PDS Details: Flu Strain
    • PDS Details: Indication
    • PDS Details: Indication/Intended Use
    • PDS Details: Package Set
    • PDS Details: Reference Strain
    • PDS Details: Substance
    • Pharmaceutical Product
    • Product
    • Product Family
    • Reference Active Ingredient
    • Registration Attachment
    • Registration FPP Attachment
  • The following additional tabs are added to the Full Product Presentation Attributes page:
    • Activities
    • Workflows

With Calyx RIM 6.2, it is now possible to associate a Package Set to a Registration via workflow.

Find

The Find > Activities functionality, available on the Calyx RIM home page, has been enhanced with a new Workflow-related report and now enables you to find the activities associated with the XEVMPD-related entities. The Entity Type drop-down list available on the View Activities List page is updated with a new entity type named XEVMPD.

SPOR Integration

To support the integration with EMA OMS and RMS API, to enable adding the controlled vocabulary for organisations and referentials data from the external system, and to enable the authentication between Calyx RIM system and SPOR API client, Calyx RIM 6.2 provides the ability to enable and configure the SPOR services through the appropriate options in the insightConfig.bat or insight.var files:
  • In the insightConfig.bat file, in the newly introduced SPOR API Settings section, values for the Enable SPOR API for RMS, Enable SPOR API for OMS, Defined Interval (minutes), User Name, and Password options must be set.

OR

  • In the insight.var file, in the newly introduced SPOR API SETTINGS section, values for the spor.api.enable.rms, spor.api.enable.oms, spor.api.update.interval.minutes, spor.api.user, and spor.api.password options must be set.

XEVMPD Submission Wizard

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].

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.
Important: If any Package Set is associated to the Registration, but is not associated to the Full Product Presentation under the Registration, then the Active Ingredient, Substance, Indication/Intended Use (non-Veterinary), or Species Indication (Veterinary) Details of the parent Product Details Set are not included in the XEVMPD submission.
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.
Calyx RIM 6.2 enhances the Package Set Registration entity by adding the new field named Legal Basis. The Registration > Legal Basis value is included in 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.

Calyx RIM 6.2 provides an additional enhancement to the XEVMPD submission data collection features and now allows the Route of Administration value to be taken into an XEVMPD submission from the PDS level. A new configured field named Local Route of Administration for tracking country Route of Administration on the PDS level has been added to the PDS Attributes page. This field is hidden by default and can be enabled via the overrides.

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. To be able to proceed with the wizard and have the MFL tag included in the submission XML file, the MFL value on the Registration Attributes page must be defined.
Note: The MFL value is mandatory for Insert, Update and Invalidate MA operation types.
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

See Entity Fields Added: Calyx RIM 6.2, Entity Fields Updated: Calyx RIM 6.2 and Data Administration Tables: Calyx RIM 6.2

Create Submission Wizard

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

See Entity Fields Updated: Calyx RIM 6.2

Change Submittal Status Wizard

Calyx RIM 6.2 enhances the logic of 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.

See Entity Fields Updated: Calyx RIM 6.2

Submitted Views

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.

Assemblies

The following Assembly enhancements have been introduced in Calyx RIM 6.2:

  • Search for the folder and leaf assembly elements by the values of the extended attributes.
  • Search for leafs that are operated in parallel sequences.
  • When filtering an assembly tree, you can now select a node type as a criterion to narrow the search results.
  • Ability to select and delete multiple assembly nodes simultaneously.
  • The delete (Withdraw) lifecycle operation is now available in the right-click menu for multiple selected leafs.

Volumes

Calyx RIM 6.2 provides the ability to delete the first and the last elements in a Volume:
  • Assembly tree elements can be deleted from the Locked Volume
  • Assembly tree elements can be deleted from the Unlocked Volume

After the element is deleted, the volume structure will be adjusted automatically to start, finish, or continue from the next or previous assembly tree element within the volume range.

Queries

Calyx RIM 6.2 provides the following enhancements to the List of Applications with Products Registration Planning and Tracking query:
  • You can now search for all application types available in the system. All application types are displayed and available for selection in the Application Type multi-select list.
  • The Application Name field has been renamed to be Application Name/Study Number. The Application Name/Study Number field is displayed on the List of Applications with Products Query search criteria selection page and appears as a column on the Search Results page.
Calyx RIM 6.2 enhances the Entity Audit Trail Administration Query for the Full Product Presentation entity to include the newly introduced fields:
  • Formulation Part
  • Intended Use Part
  • Target Population Part
  • Container or Pack Part
  • Device Part
  • Time Period Part
  • Flavour Part

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.

To reflect renaming of the Excipient Role field for the Substance Detail as Substance Role and the Excipient Name to a Substance Name, the following Administration and Product Details Management queries have been updated to display Substance Role and Substance Name column names:
  • Application History Query > Substance Details Changed? subquery
  • Application QC Status History Report > Substance Details QC Passed? subquery
  • Entity Audit Trial > Product Detail-Substances entity type
  • List of Excipient Manufacturers
  • List of Registrations with Excipients
To support the enhancement to display the Manufacturer Name value as a concatenation of Manufacturer Name + Address Line 1 + Country Code values, the following queries have been updated:
  • Queries > Registration Planning and Tracking:
    • List of Manufacturers From Data Administration
  • 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
To support the Withdraw Country enhancement, Calyx RIM 6.2 introduces a new Product Detail Management query named List of Application Countries with PDS Country and Registration Details. This is designed to query for countries based on the Application Country information as well as the related PDS Country information: Registration, Registration Package Set, and Registration Package Set Country information. The hyperlinked attributes on the report Search Results page will navigate you to the related entity attributes page. The following queries have been updated with a new drop-down list named Applications with Withdrawn Country:
  • Registration Planning and Tracking > List of Application Countries with Registration Details
  • Product Detail Management > List of Application Countries with Registration and Product Details
  • Submission Planning and Tracking > List of Application Countries
The following reports have been updated to support the renaming of the Event Closed As field to Associations Closed As and the Event Closed Date field to Closed Date on the Event attributes page:
  • Querying > Registration Planning and Tracking queries:
    • List of Products with Event and Product Registration Details
    • List of Events with Application Properties
    • List of Sequences with Application and Event Properties
  • Querying > Product Detail Management queries:
    • Application History Query
    • Application QC Status History Report
    • List of Product Detail Sets
  • Querying > Registered Document Analysis > Registered Document Query.
  • Event Attributes > Entity History Query
To support the enhancement of providing the ability to identify the association between the parent Task and its Sub-Task, the following Registration Planning and Tracking queries 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 also introduced to support this enhancement:
  • The listed Registration Planning and Tracking queries 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, navigates you to 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.

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.

Search

The SEARCH function on the menu bar now includes the ability to search for sequences. You can search for sequences filtered by specific text found in the Name, Code, Keywords, or Description attributes.

To support the enhancement of providing the ability to identify the association between the parent Task and its Sub-Task, the Related Task Name column has been added to the Search Results page of the SEARCH function on the menu bar when invoked for the Tasks/Sub-tasks option. The value in the column is hyperlinked. When selected, navigates you to the appropriate Task Attributes page.

Analytics

The Analytics Schema (DM schema) has been updated:
  • The DM schema includes views for reporting on audit data.
  • All views affected by changes in this release are also updated in the DM Schema.
  • The DM schema was updated with the view containing chronological representation of Sequences and References.

Analytics Predefined Reports

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.
The XEVMPD Audit Analytics Predefined Report logic for displaying the following list of entities has been updated to consider the Package Set-Full Product Presentation association instead of the Package Set-Registration:
XEVMPD Entity Type InSight Entity Type
Authorised Product - Authorisation PDS
Authorised Product - Product Indications Indications/Intended Use
Pharmaceutical Product Pharmaceutical Product
Pharmaceutical Product - Active Ingredient Component Active Ingredient
Pharmaceutical Product - Active Ingredient PDS Active Ingredient
Pharmaceutical Product - Active Ingredient PDS Substance
Pharmaceutical Product - Active Ingredient Reference Active Ingredient
Pharmaceutical Product - Adjuvant Adjuvant
Pharmaceutical Product - Administration Route Component
Pharmaceutical Product - Administration Route Product
Pharmaceutical Product - Excipient Excipient
Pharmaceutical Product - Medical Devices Pharmaceutical Product

Job Requests

Calyx RIM 6.2 enhances the Job Requests functionality to work with the data exchange user and receive the results of actions performed by the user.

Data Exchange

Calyx RIM Data Exchange enables you to import the following types of records into the Calyx RIM database:
  • Legal Status Values
  • Registration Status Values
  • Event Country
  • Event Country Status
  • Product Detail Set (PDS)
    Note: To be able to import PDS data via Calyx RIM Data Exchange, the parent Event entity must have the Status ofOpen.
  • PDS Substance Component Detail
  • PDS Flu Strain Detail
  • PDS Reference Strain Detail
  • PDS Species Indication Detail
  • Region Values

Calyx RIM 6.2 enhances Data Exchange by adding the User Authentication, Authorisation, and Auditing support.

Data Administration

Calyx RIM 6.2 provides a variety of updates to Data Administration section:
  • The Region Type Values table in the Application Maintenance section has been updated with a new default region type named IDMP.
  • The Region Values table in the Application Maintenance section has been updated with a new region named IDMP Integration.
  • A new field named Organisation Identifier has been added to the following Data Administration tables:
    • Product Detail Set Maintenance > Manufacturer Values
    • Other > MAH/Development Sponsor/Oranisation Values
    • Application Maintenance > Country Values > Health Authority
  • The Procedure Type Values table in the Application Maintenance section has been updated by adding a new field named IDMP Internal Procedure Code.
  • In the Registration Maintenance > Registration Status Values, the Internal System Status field has been updated with a new internal status named APPROVED.
To maintain the integration with Organisations management service (OMS) introduced by European Medicines Agency (EMA), Calyx RIM 6.2 provides the following enhancements:
  • The Data Administration > Other Maintenance > MAH/Development Sponsor/Organisation Values table is updated by adding the following fields:
    • Location Identifier
    • Location Status
  • The following Data Administration Tables have been updated to include a new drop-down list named RMS Term Name:
    • Application Maintenance > Country Values
    • Application Maintenance > Procedure Type Values
    • Other > Concentration Measure Type Values
    • Other > Denominator Unit Values
    • Other > Language Values
    • Other > Legal Basis Values
    • Other > Numerator Unit Values
    • Other > Unit of Measure Prefix Values
    • Product Detail Set Maintenance > Compendial Designation/Source Values
    • Product Family Maintenance > ATC Values
    • Product Maintenance > Dosage/Pharmaceutical Form Values
    • Product Maintenance > Medical Device Values
    • Product Maintenance > Route of Administration Values
    • Registration Maintenance > EMA Authorisation Status Values
    • Registration Maintenance > Medicinal Product Type Values

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.

Calyx RIM 6.2 introduces the SPOR Maintenance section in Data Administration. This section is designed to maintain the European Medicines Agency (EMA) Substance, Product, Organisation and Referential (SPOR) service compliance. According to the roadmap designed by EMA the SPOR support starts with an introduction of OMS (Organisations management service) and RMS (Referentials management service) components.

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 > 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.

To identify medical devices and also facilitate data exchange between manufacturers, regulators, and healthcare authorities, Global Medical Device Nomenclature (GMDN) Code Values has been introduced under Data Administration > Product Maintenance section.

To maintain the specific detail type value of the country attribute, the Product Maintenance section in Data Administration has been updated with the following new tables:
  • Country Specific Detail Type Values
  • Country Specific Detail Values

To maintain the applicable standard version, the Applicable Standards Values table has been updated to include the Version of Standard option.

To identify, process, retrieve, transfer, and communicate data about medical devices, the UMDNS Code Values option has been introduced under Data Administration > Product Maintenance section.

For the enhancement that adds a new field named Legal Basis to the Package Set Registration entity, the Legal Basis Values table has been removed from the Data Administration > Application Maintenance section and is now included in the Data Administration > Other section.

The following tables have been removed from the Calyx RIM 6.2 Data Administration section:
  • Device Classification Values
  • FDA Regulation Number Values

See Data Administration Tables: Calyx RIM 6.2

Additional Enhancements

With support for the Microsoft Edge and Google Chrome Enterprise Edition browsers, Calyx RIM 6.2 provides the ability to display all windows throughout the system with Kendo (HTML5 user interface framework).

Note: Calyx RIM 6.2 supports Microsoft Edge and Google Chrome Enterprise Edition browsers only when configured for Kendo. When not configured for Kendo, LIQUENT InSight 6.2 supports only Microsoft Internet Explorer 11.
The Kendo-styled windows can be minimized, maximized, moved, and re-sized. When the settings are configured to support Kendo, using one of the following methods, then all windows will be displayed in the newly supported browsers:
  • In the insight.var file, the insight.window.type.kendo=true setting must be added.

    If the setting is insight.window.type.kendo=false, then all windows are displayed in standard style.

OR

  • In the insightConfig.bat file, in the Browser Independence Settings section, the Enable Kendo Window UI option is set to true: Enable Kendo Window UI=true.
    The default value is set to true. If the default value is preserved, then all windows are displayed in kendo style.
    Attention: Please note that Calyx RIM for Analytics module is not compatible with the Microsoft Edge browser.

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

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

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*

*Requires additional hardware.

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.