Manage Concurrently Planned Sequences
As you work on multiple planned sequences, it is important to understand how the submitted view is created. When you create the working assembly, the submitted view is a cumulative snapshot of all the sequences you have submitted. Once a submitted view is created for a planned assembly, it does not change.
If you are working on two planned sequences at the same time, they are both based on the same submitted sequence. In the example below, the submitted view of both P0001 and P0002 are based on 0000, which is the only submitted sequence.
You may submit P0002 to the regulatory agency before you submit P0001. The approved view is based on what has already been submitted, and enables you to make and view your changes. Both of these sequences may modify the same eCTD sections, and in fact they may modify the same eCTD leaf elements.
In the example above, when P0001 is submitted, it does not show the changes in the P0002 Submitted and working views. However, sequences P0001 and P0002 may still be submitted in any order. As each sequence is submitted, it looks for other planned sequences that have leafs in common with it. If these other planned sequence's leafs all have REPLACE leaf operations, they are automatically updated to point to the common leafs in the current sequence. It is extremely important to confirm leafs that are in common between the sequences after submittal, to make sure the correct document versions have been included in each case.
For a more specific example, suppose that in P0001 a leaf containing drug product information is updated in section 3.2.P.1. This information is also updated in P0002 with different data. The change in P0001 is an APPEND to the 3.2.P.1 leaf, and the change in P0002 is a replace to the 3.2.P.1 leaf. If P0002 is submitted before P0001, the REPLACE leaf in 3.2.P.1 updates the NEW 3.2.P.1 leaf in sequence 0000. If sequence P0001 were published before running the submittal wizard, its APPEND to the 3.2.P.1 leaf would point to the leaf in sequence 0000. If this is incorrect, P0001 would have to be submitted first and synchronized with the lifecycle. Once this was done, the APPEND leaf in 3.2.P.1 would point to the REPLACE 3.2.P.1 leaf in P0002.
In a similar example suppose that in P0001 a leaf containing drug product information is updated in section 3.2.P.1. This information is also updated in P0002 with different data. The change in P0001 is a REPLACE to the 3.2.P.1 leaf, and the change in P0002 is also a REPLACE to the 3.2.P.1 leaf. If P0002 is submitted before P0001, the REPLACE leaf in 3.2.P.1 updates the NEW 3.2.P.1 leaf in sequence 0000, and then updates the REPLACE leaf in sequence P0001. If sequence P0001 were published before running the submittal wizard, its REPLACE to the 3.2.P.1 leaf would point to the leaf in sequence P0001.
In this way, the eCTD XML is verified to be 100% correct with a valid lifecycle. Of course, in the act of submitting P0002 forces the sequence code to change to 0001, and when P0001 is submitted, the wizard again forces the sequence code to change to 0002. This is how Ennov InSight enforces consistency of the lifecycle to help prevent compliance issues later.
If many changes have been made to P0001 that you must compare with what is showing in P0002, you can use the Assembly Comparison query to view the differences between the planned sequences. This can help you determine the changes you need to make in the unsubmitted planned sequence.
As implied in the second example above, more than one planned sequence may be created and added in any order. The same leaf files may even be REPLACED, and as long as both are added to the submitted view and the XML is republished, both are valid sequences. The only situation that cannot be handled is if sequence P0002 has a DELETE operation on a leaf, and sequence P0001 attempts to REPLACE or APPEND on that same leaf. This will trigger an error when sequence P0001 is added to lifecycle, because it is an illegal eCTD operation. You can use the Assembly Comparison query to view the differences between the planned sequences. This can help you determine the changes you need to make in the unsubmitted planned sequence.