Calyx RIM 6.2 Release Notes

Entity Fields Updated: Calyx RIM 6.2

The following table describes fields that were updated or removed with Calyx RIM 6.2.

Entities

Entity Name Field Name Field Type Description Business Rules
Application Application Status Drop-down list Starting with Calyx RIM 6.2, the Application Status of an Application can be set to Withdrawn only when all Registrations associated to this Application have a status mapped to internal WITHDRAWN status. The following wizards have been updated to reflect this enhancement:
  • Update Status
  • Update Event-Country Status

If you set Associations Closed As to WITHDRAWN, the Application Status will be set to Withdrawn only when all Registrations associated to this Application have a status mapped to internal WITHDRAWN status.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 Associated Registration(s) must be Withdrawn prior to the Application.

Application Country Withdraw Date Date When an Event is closed as Approved and the PDS associated to this Event has a withdrawn Country Detail, displayed as Country (Pending Withdrawal), the parent Application Country > Withdraw Date field is automatically updated to be equal to Event > Closed Date field value. The following explains specific conditions that governs the Application Country > Withdraw Date field change:
  • If Application Country does not have the Withdraw Date value and the Event is closed with today's date, -1 day (or more) before today's date, or +1 after today's date, then the Application Country > Withdraw Date inherits the Event > Event Closed Date value.
  • If Application Country has the Withdraw Date field set to today's date and the Event is closed with -1 day (or more) before today's date, or +1 day after today's date, then the Application Country > Withdraw Date inherits the Event > Event Closed Date value.
  • If Application Country has the Withdraw Date field set to a date greater then +2 days (or more) after today's date and the Event is closed with today's date, -1 day (or more) before today's date, or +1 day after today's date, then the Application Country > Withdraw Date inherits the Event > Event Closed Date value.
The Application Country > Withdraw Date is not updated, if:
  • The Application Country > Withdraw Date value precedes the Event > Event Closed Date value and both dates are in the past.
  • The Event > Event Closed Date value is equal to Event > Event Closed Date value.
  • The Event > Event Closed Date is set to today's date -1 day and the Event > Event Closed Date is set to today's date.
Comparator Suppliers Multi-select list The Manufacturer Name value is now displayed as a concatenation of Manufacturer Name + Address Line 1 + Country Code. No updates to the business rules.
Full Product Presentation Full Product Presentation Comments Display The field has been enhanced to be a display-only field that includes the previously added comments. Can be updated or deleted from the View Full Product Presentation Attributes page. Available on the View/Modify Full Product Presentation Attributes pages. Includes all comments entered by users, including the date and time the comments were entered, and the user ID of the person who entered them.
MPID Text The unique identifier allocated to a Medicinal Product supplementary to any existing authorization number as ascribed by a Medicines Regulatory Agency in a jurisdiction. The MPID field has been hidden on the Full Product Presentation View, Create and Modify pages.
Important: The MPID values are displayed in the Entity Audit Trial report for the Full Product Presentation entity.
Previous EV Code N/A The Previous EV Code drop-down list has been reworked to be the FPP Previous EV Codes tab on the Full Product Presentation Attributes page.
  • Field Type: text, required
  • Field Size: 60 characters
  • Database Field Size: VARCHAR2(100)
If there are several Previous EV Code values, in the XEVMPD XML file that results in several <previousevcode> tags.
Event Comment Text The field has been renamed to be Event Add Comment. Only the field display name has been changed.
Countries Multi-select list Business rules for the Countries field on the Create Event page have been changed. Withdrawn application countries with the Withdraw Date value equal to today’s date or earlier are not available for selection in the Countries multi-select field on the Create Event page. This is applicable only to applications of Mutual Recognition (MRP) or Decentralised Procedure (DCP) types.
Event Closed As Multi-select list The field has been renamed as Associations Closed As. Only the field name has changed.
The following pages, tables, and tabs have also been updated to display Associations Closed As column name:
  • Home Page > Events table
  • Application > Events tab
  • Project > Event Change Details tab
  • View Comparator page
  • View Clinical Trial Shared Data page
Event Closed Date Date The field has been renamed as Closed Date:
  • View Event Attributes page for the closed events.
  • Modify Event Attributes page, if the Closed checkbox is selected.
Only the field name has changed.
The following pages, tables, and tabs have also been updated to display Closed Date column name:
  • Home Page > Events table
  • Application > Events tab
  • Project > Event Change Details tab
  • View Comparator page
  • View Clinical Trial Shared Data page
Pharmaceutical Product Add Pharmaceutical Product Comment Text The field has been renamed to be Pharmaceutical Product Add Comment. Only the field display name has been changed.
Product Add Product Comment Text The field has been renamed to be Product Add Comment. Only the field display name has been changed.
Product Strength Measure 1 Numeric Product Strength Measure 1 field has been enhanced to display a leading zero value for the decimal numbers that are less than 1 on the View Product Attributes page for the:
  • Pharmaceutical Product Family
  • Flu Vaccine Product Family
  • Pharmaceutical-Medical Device Product Family
  • Veterinary Product Family

For example, if you are entering 0.1 value in the Product Strength Measure 1 field, it will be displayed in the Product Attributes > Product Strength field including the leading zero, and followed by the Product Strength Unit 1 value, if any:

0.1 mg

The business rules for the field have been enhanced. The entered value must not exceed 5 decimal numbers before the decimal point and 5 decimal numbers after the decimal point. Value cannot be larger than 99999.99999.
Product Strength Measure 2 Numeric Product Strength Measure 2 field has been enhanced to display a leading zero value for the decimal numbers that are less than 1 on the View Product Attributes page for the:
  • Pharmaceutical Product Family
  • Flu Vaccine Product Family
  • Pharmaceutical-Medical Device Product Family
  • Veterinary Product Family

For example, if you are entering 0.2 value in the Product Strength Measure 2 field, it will be displayed in the Product Attributes > Product Strength field including the leading zero, and followed by the Product Strength Unit 2 value, if any:

0.2 g

The business rules for the field have been enhanced. The entered value must not exceed 5 decimal numbers before the decimal point and 5 decimal numbers after the decimal point. Value cannot be larger than 99999.99999.
Product Detail Set Specialty Number Text This value is a part of mrpnumber for XEVMPD. The field has been renamed to be Speciality Number. The concatenation formula is: [Procedure Identifier/Application Code][Speciality Number1]'-'[Speciality Number2], if there are two PDSs associated to the Full Product Presentation and the Speciality Number2 value is different from Speciality Number1 value.
Manufacturer Drop-down list The Manufacturer Name value is now displayed as a concatenation of Manufacturer Name + Address Line 1 + Country Code in the Manufacturer drop-down list for each instance of the Manufacturer Detail in the Product Detail Set:
  • Component > Active Ingredient > Manufacturer
  • Component > Active Ingredient > Manufacturing Process > Function > Manufacturer
  • Component > Substance > Manufacturer
  • Component > Substance > Manufacturing Process > Function > Manufacturer
  • Component > Manufacturing Process > Function > Manufacturer
  • Component > Function > Manufacturer
  • PDS > Manufacturing Process > Function > Manufacturer
  • Package Set > Function > Manufacturer
  • Package Set > Packaging > Manufacturer
  • Package Set > Component > Packaging > Manufacturer
All active values from the Data Administration > Product Detail Set Maintenance > Manufacturer Values table are available for selection.
Country Multi-select list Business rules for the Country field on the Add Country page have been changed for the Product Detail Set > Countries detail. Withdrawn application countries with the Withdraw Date value equal to today’s date or earlier are not available for selection in the Label Country drop-down list on the Add Country page. This is applicable only to applications of Mutual Recognition (MRP) or Decentralised Procedure (DCP) types.
Label Country Drop-down list Business rules for the Label Country field on the Add Label page have been changed for the Product Detail Set > Labels detail. Withdrawn application countries with the Withdraw Date value equal to today’s date or earlier are not available for selection in the Label Country drop-down list on the Add Label page. This is applicable only to applications of Mutual Recognition (MRP) or Decentralised Procedure (DCP) types.
Countries Multi-select list Business rules for the Counties field on the Add/Modify Manufacturer pages have been changed. Applicable 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 Details Set Manufacturing Process Step Material
  • Substance
  • Substance Manufacturing Process Function
  • Substance Manufacturing Process Step Function
  • Substance Manufacturing Process Step Material
Withdrawn application countries with the Withdraw Date value equal to today’s date or earlier are not available for selection in the Countries multi-select field on the Add/Modify Manufacturer page. This is applicable only to applications of Mutual Recognition (MRP) or Decentralised Procedure (DCP) types.
Countries Multi-select list Country (countries) for which this detail is created. Defines the value that is included to the XML file during the XEVMPD Submission wizard execution. The business rules are changed for the field. Applicable to:
  • Product Detail Set (Non-Veterinary): Indication/Intended Use Detail
  • Product Detail Set (Veterinary): Species Indication
By default, all countries associated to the Application appear in the Selected box of the Countries field on the Add Indication/Intended Use detail (Non-Veterinary) and Add Indication (Veterinary) pages.
Note: The exceptions are application countries with the Withdraw Date value equal to today’s date or earlier. Such countries are not available for selection in the Countries field on the Add/Modify Indication/Intended Use (Non-Veterinary) and Add/Modify Indication (Veterinary) pages. This is applicable only to applications of Mutual Recognition (MRP) or Decentralised Procedure (DCP) types.

You can deselect countries, if needed.

Excipient Role Drop-down list The field has been renamed as Substance Role and is now available regardless of the selected Substance Type value. Applicable to:
  • Product Detail Set: Substance Detail
  • Product Detail Set Template: Substance Detail

The Substance Role value is displayed in the PDS Tree as a part of Substance Name (Substance Type + Substance Name + Substance Role). The uniqueness rule concatenation is the following: Substance Type + Substance Name + Substance Role.

Only the field name has changed.
The following reports have also been updated to display Substance Role and Substance Name column names:
  • Querying > Product Detail Management > Application History Query > Substance Details Changed? subquery
  • Querying > Product Detail Management > Application QC Status History Report > Substance Details QC Passed? subquery
  • Querying > Administration > Entity Audit Trail > Product Detail-Substances entity type
  • Querying > Product Detail Management > List of Excipient Manufacturers
  • Querying > Product Detail Management > List of Registrations with Excipients
Project Project Pivot Status Drop-down list With Calyx RIM 6.2, the following are updated with a new PLANNED status available for selection:
  • 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).
N/A
Registration License Comments Text The field name has been renamed to be License Add Comment. Only the field display name has been changed.
Country Drop-down list Business rules for the Country field on the Create Registration page have been changed for the:
  • Package Set Registration
  • Product Registration
Withdrawn application countries with the Withdraw Date value equal to today’s date or earlier are not available for selection in the Country drop-down list on the Create Registration page. This is applicable only to applications of Mutual Recognition (MRP) or Decentralised Procedure (DCP) types.
Registration Attachment Attachment Name Text Using XML overrides, Calyx RIM 6.2 can be configured to disable the autopopulate function for the Attachment Name field. Only applicable if the Attachment file is uploaded from the DMS Repository.
Attachment Version Text Using XML overrides, Calyx RIM 6.2 can be configured to disable the autopopulate function for the Attachment Version field. Only applicable if the Attachment file is uploaded from the Documentum DMS Repository.
File Name Text Using XML overrides, Calyx RIM 6.2 can be configured to disable the autopopulate function for the File Name field. Only applicable if the Attachment file is uploaded from the DMS Repository.
File Type Drop-down list Using XML overrides, Calyx RIM 6.2 system can be configured to disable the autopopulate function for the File Type field. Only applicable if the Attachment file is uploaded from the DMS Repository.
Registration FPP Attachment Attachment Comments Text The field has been renamed to be Registration FPP Attachment Comments. Available for modifications on the Create/Modify Registration FPP Attachment Attributes pages.
Attachment Concerned Parties Text The field has been renamed to be Registration FPP Attachment Concerned Parties. Only the field display name has been changed.
Attachment Name Selection list The field has been reworked to be a Selection list on the Create Registration FPP Attachment Name page. The system returns the results after clicking the Select icon next to the Attachment Name > Selected box. The selected Registration Attachment will be displayed in the Attachment Name > Selected box in the concatenation of four fields: Internal Name, Attachment Language, Attachment Name, Attachment Version. Only one Registration Attachment can be selected. The search results page displays all Active Registration Attachments available in the system.
Important: The registration attachments, already associated to the current Full Product Presentation, are not displayed.
Application Procedure Type Display N/A (attribute is removed)
Authorisation Status Display The status of the authorisation of a medicinal product. N/A (attribute is removed)
Authorised Pharmaceutical Form Display The pharmaceutical form of the product. N/A (attribute is removed)
Language Display N/A (attribute is removed)
Product Form Display The physical form in which this product is produced and dispensed. N/A (attribute is removed)
Product Strength Display The value used to define the product strength. N/A (attribute is removed)
Withdrawn/Invalidated Date Display The date of expiry of the marketing authorisation. N/A (attribute is removed)
XEVMPD MAH/Organisation Display The current XEVMPD MAH/Organisation from the Full Product Presentation entity. N/A (attribute is removed)
XEVMPD Marketing Authorisation Number Display The current XEVMPD Marketing Authorisation Number from the Full Product Presentation entity. N/A (attribute is removed)
Sequence Concerned Member States Multi-select list Business rules for the Concerned Member States field on the Create Sequence page have been changed. Withdrawn application countries with the Withdraw Date value equal to today’s date or earlier are not available for selection in the Concerned Member States multi-select field on the Create Sequence page.
Sequence Comments Text The field has been renamed to be Sequence Add Comment. Only the field display name has been changed.
Task

(Sub-Task)

Assigner Drop-down list Person responsible for creating the task. The business rules have been changed. Only active users are available for selection. The inactive or disabled users are omitted from the lists of available values.
Premier Assignee Drop-down list Calyx RIM user that has been assigned to this task. The business rules have been changed.
Task Concerned Parties Selection list Contains email addresses and/orCalyx RIM User IDs for which Notifications can be sent. The business rules have been changed.

Wizards

Wizard Name Field Name Field Type Description Business Rules
Change Submittal Status > Complete Submission Status Properties Confirmed Sequence Code Text 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. All previously submitted sequences are taken into account, even if the current Sequence Status is set to Approved.
Create Submission wizard > Initial Application > Complete Submission Properties (event/sequence) Event Type Drop-down list The Event Type field is now available for modifications. The drop-down list displays all Active values from Data Administration > Event Maintenance > Event Type Values. The New Application value is selected by default in the Event Type field.
Find > Activities > View Activities List Entity Type Drop-down list The Find > Activities functionality, available on the Calyx RIM Home Page, has been enhanced and now provides an ability 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. When XEVMPD is selected in the Entity Type drop-down list, the following list of filters is displayed on the View Activities List page:
  • Entity Type Specific Filters:
    • Product Family Type
    • Product Family Name
    • PSet Registration
  • Common Filters:
    • Assigned User (multi-select list)
    • Assigned User (text field)
The following columns are available on the Search Results page:
  • Activity name
  • Assigned User
  • Related Workflow
  • Related Entity
  • Parent Entity (The Parent entity for all activities of XEVMPD type is the corresponding Full Product Presentation)
  • Due Date
  • Priority
  • Paused
Global Project Plan > Add Manufacturer:
  • 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
Manufacturer Drop-down list The Manufacturer Name value is now displayed as a concatenation of Manufacturer Name + Address Line 1 + Country Code. No updates to the business rules.
Project > Event Country Dates > Update Project Event Country Status, if the Close Event? drop-down field is set to Yes Event Closed As Multi-select list The field has been renamed as Associations Closed As. Only the field name has changed.
The following pages, tables, and tabs have also been updated to display Associations Closed As column name:
  • Home Page > Events table
  • Application > Events tab
  • Project > Event Change Details tab
  • View Comparator page
  • View Clinical Trial Shared Data page
Event Closed Date Date The field has been renamed as Closed Date. Only the field name has changed.
The following pages, tables, and tabs have also been updated to display Closed Date column name:
  • Home Page > Events table
  • Application > Events tab
  • Project > Event Change Details tab
  • View Comparator page
  • View Clinical Trial Shared Data page
Update Status > Update Event Country Status page, if the Close Event? drop-down field is set to Yes Event Closed As Multi-select list The field has been renamed as Associations Closed As. Only the field name has changed.
The following pages, tables, and tabs have also been updated to display Associations Closed As column name:
  • Home Page > Events table
  • Application > Events tab
  • Project > Event Change Details tab
  • View Comparator page
  • View Clinical Trial Shared Data page
Event Closed Date Date The field has been renamed as Closed Date. Only the field name has changed.
The following pages, tables, and tabs have also been updated to display Closed Date column name:
  • Home Page > Events table
  • Application > Events tab
  • Project > Event Change Details tab
  • View Comparator page
  • View Clinical Trial Shared Data page
XEVMPD Submission > Select Sender/Receiver Information page Run Initial Report? Drop-down list 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.