Calyx RIM for Registrations

Approved Status Views

Sequences are added to a lifecycle and dispatched to a regulatory agency for approval based on your organization's and the agency's internal procedures.

Each sequence is associated with an event and each event may have multiple sequences associated with it. An event enables you to track the submission approval process.

In this capacity, an event is a grouping of sequences under one business objective, for example, an initial filing. As you submit sequences, they are added to the Submitted Views tab on the Home page and the Application Attributes page.

Sequences can be approved by the agency in a different order from which you submitted them. After the agency approves the submitted sequences, you can approve the associated event by adding it to the approved view.
Note: Approved status views are available to RDA module licensed users only.

The submission process can be illustrated as follows:

Application - Initial Filing

Event Sequences Submitted Approved
EVENT-01

SQ-0001

SQ-0002

SQ-0003

01-01-2007
EVENT-02

SQ-0004

SQ-0005

02-01-2007 02-15-2007
EVENT-03 SQ-0006 03-01-2007

In the table above,

  • Events 01-03 are associated with an Application - Initial Filing.
  • Event-01 comprises sequences 0001-0003 and was submitted to the regulatory agency for approval on January 1, 2007. It has not yet received approval.
  • Event-02 comprises sequences 0004 and 0005 and was submitted to the regulatory agency February 2, 2007. It received approval from the agency February 15, 2007.
  • Event-03 comprises sequence 0006 and was submitted to the regulatory agency March 1, 2007. It has not yet received approval.

When you add an event to the approved view, the following occur:

  • The first application approval date is set.
  • The event is closed.
  • The event status is changed to Approved with the appropriate time stamp.
  • The sequence statuses are changed to Approved with the appropriate time stamp.
  • Any pending product details are approved.
  • The event is added to the Approved Views tab.