Verifying and Reporting COI/COC

This lesson will enable you to print the chain of identity report for a finished product and show you how to review and monitor COI events.

We have now completed the full process of receiving a treatment order, managing the biospecimen for it, manufacturing the finished product for it and delivering this personalized treatment back to the treatment order for the eligible patient. To verify this complete journey of a finished product, you can print the Chain of Identity report in SAP Cell and Gene Therapy Orchestration.

To start this process, we navigate to the treatment order overview by using the COI ID in the Manage Orders in the Treatment Management section of the SAP Cell and Gene Therapy Orchestration landing page.

In the treatment order overview, switch to the Shipments section and click on the shipment in the list of shipments for the finished product shipments that you want to print the COI report for. This will open a menu where you chooseAllocate Batches to Shipment to return to the allocated batches to this shipment. In case the Allocate Batches to Shipment is not visible, click first on More Links and switch Allocate Batches to Shipment on.

In this screen, you can now select the allocated batch of the finished product that you would like to print the COI report for by selecting it and clicking on the arrow pointing to the right.

To generate the COI report for the allocated batch of the finished product that you selected, click on the text saying Generate COI Certificate in the Documents section. This step will require your e-signature and will open a new screen that will compile data for this batch including PHI data.

Here, you can review and verify the COI report which will contain the patient information, the biospecimen information and also the product information for this batch of the finished product. To save it, click on the Save button on the bottom right.

This will add the COI report to the documents associated with this batch which you can review/verify on the batch overview page.

In addition to printing COI reports for individual batches of the finished product, you can also review all COI events associated with an order.

You will find the Monitor COI application in the COI/COC section on the landing page of SAP Cell and Gene Therapy Orchestration. In the next screen, enter the COI ID of interest and click on the Go button on the right.

First, you will see the graphical view of all COI events associated with this COI ID in a condensed way. To expand and view the details of one category, click on the arrow pointing down in the respective box. In this view, you can zoom in and out and move in the view to find and review the events of interest. Depending on the treatment order, the therapy and the flow version, this view can have many or few events.

You will see the key information for a COI event on the graphical view, but you can also get more details by clicking on the event and then on the button with four dots and lines next to the event and then clicking on View Details. This opens an additional window with more details. The available information will depend on the type of event. To get the compete details for this event, you can also click on View Details which will bring you directly to the overview for this event with all associated information and logs.

Going back to the Monitor COI view, you can also change to the tabular view here by clicking on Tabular View on top. This will show all COI events as a list which you can sort and filter. To review the event details for a specific event, you can click on the arrow pointing to the right.

This concludes this lesson.