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Change Request - Data Models

Directions

As a group, read through the following Change Request and implement the requirements in L7|ESP.

Important

Timing: You have 60 minutes to complete this stage of the project, after which we will debrief as a group.

Item Types

  1. 2 L CellBag

    1. Consumed in bag(s)

    2. Manufacturing Operations wants to know when the inventory is below 10 bags

    3. Manufacturing Operations reorders 100 bags from Cytiva

  2. 500 mL T Cell Expansion Medium

    1. Consumed in bag(s)

    2. Manufacturing Operations wants to know when the inventory is below 10 bags

    3. Manufacturing Operations reorders 100 bags from Cytiva

Important

Testing: Create Items from these Item Types in the Inventory app. Each Item should be verified and expire in the future.

Container Types

  1. Xuri Kit

    1. The Kit has a single dimension labeled numerically

    2. The Kit can store multiple Items at specified quantities:

      1. 2 L CellBag

        1. min: 1

        2. max: 2

      2. 2 mL Cryovial

        1. min: 2

        2. max: 4

      3. 3 mL Syringe

        1. min: 2

        2. max: 4

      4. 500 mL T Cell Expansion Medium

        1. min: 1

        2. max: 2

  2. LN2 Box used to store T Cell Samples

    1. 9x9 Box

      1. Each location can store one (1) T Cell Sample

      2. The labels should read A1 through I9

  3. Update the LN2 Rack to only store LN2 Boxes

Important

Testing:

Create Containers from these Container Types in the Location app. Transfer the max quantity of each Item Type assigned to the Xuri Kit. Do not assign the Kit a status.

Create a location hierarchy in the LN2 Tank - add one (1) LN2 Rack to a quadrant in the LN2 Tank and one (1) LN2 Box to a slot in the LN2 Rack.

Entity Types

Note

The Entity ID Sequence for the Xuri Process Control Sample must first be configured before it can be assigned to this Entity Type.

  1. CAR T Batch

    1. Update this Entity Type by adding fields to assign the Sepax Kit, CliniMACS Kit, and Xuri Kit to the Batch. Do not restrict Containers by status or update this status after use.

  2. Xuri Process Control Sample

    1. Class: Sample

    2. Custom fields:

      1. Sampling Date Time in the format YYYY-MM-DD HH:mm Z

      2. Sampling Reason with the options:

        1. Cell Counting

        2. Sterility

    3. ID Sequence format: XPC001

Important

Testing: Create Entities from these Entity Types in the Entities app.

In this section: