Creating a Batch Run (v6.5.X)

VERSION NOTE:
Batch Runs can be created in all supported versions of Tempo MES. This article provides an overview of creating batch runs in Tempo v6.5.X, as well as links to related articles. For information about creating a batch run in Tempo v7.X.X, review the Creating a Batch Run (v7.X.X) article.

Starting a new batch run

Follow the steps below to start a new batch run in the Tempo web application.

1. Click cloud Tempo > Batches > Runs. The Batch Runs page displays.
2. Click Start New Batch Run. The Start Batch Run dialog displays.
3. Select or enter the information in the required fields:
   • Batch Run ID: The name of the batch run. Each batch run ID needs to be unique.
   • Batch Template: Select the name of the effective batch template to use for this batch run.
4. Select or enter the information in the optional field:
   • Product Material: Select the material that this batch will produce. This also filters the list of templates in the Batch Templates field to only those that are able to produce this material.
5. Click Next. A General Information (Continued) field section displays.
6. Access to the fields in this section depends upon the Product Material selection from step 4.
   • If you selected a Product Material in step 4, the following optional fields can be completed:
     • Lot Number (for primary output): Set the lot number for any primary output material created in this batch run.
     • Batch Quantity: Set the target batch quantity. (This is an informational field only).
     • Unit of Measure: Set the unit of measure for the target batch quantity. (This is an informational field only).
   • If you did not select a Product Material in step 4 or do not wish to enter this information, click Next.
7. Click Next. A General Information (Continued) field section displays.
8. Select or enter the information in the required fields:
   • Start Date: Select the start date for this batch run.
   • End Date: Select the end date for this batch run.
9. Select or enter the information in the optional fields:
   • Campaign: Campaigns are a tool for filtering runs. Select or add a campaign, if applicable to this batch run. (To add a campaign, click the field and begin typing, then click Create New.)
   • Location ID: Select the location for this batch run.
   • Notes: Enter notes for this batch run.
10. Click Create. If the Require signature to create a batch run setting is enabled in your system, you may be asked to enter your system Email, Password (or PIN), and a Comment. Once complete, the new batch run displays.

Managing & configuring a batch run

Each batch run begins in the Created stage. In this stage, a web app user can:

• Update parameter values on the Parameters tab
• Update batch run information like the start date, end date, campaign, and location on the Information tab.
• Update batch-run-specific configurations like Allow Batch Run Modification and Enable redlining for all procedures within this batch on the Information tab.
• Assign users for batch execution on the Assign tab. (Batch execution is only available during the In Progress stage.)
• Add documents or replace placeholders on the Documents tab.
• Print a batch run report from the Batch Run Report button in the batch run header.

As a batch run progresses further in the batch run lifecycle, elements like parameter values and batch information become locked. Additionally, after a batch run is in progress, the ability to approve exceptions becomes available on the batch run. For more information about the batch run lifecycle, review the Batch Run Lifecycle & Stages Overview article. For more information about approving exceptions, refer to the Reviewing & Approving an Exception article.

Updating parameter values

1. From the relevant batch run, click Parameters.
2. To apply an effective batch parameter group for this batch template version, click Use Parameter Group; otherwise, skip to step 5.
3. Select the name of the parameter group to apply, then click Apply.
4. Enter your system Email, Password (or PIN), and a Comment.
5. Review each parameter value on the Parameters tab. To edit a parameter value, click the edit Edit icon, then review editable fields and make any necessary updates.
   • Value Type: Choose between Static or Dynamic, if applicable. (Static values are fixed. Dynamic values are determined by an input or action from a previous procedure in the batch template.)
   • Default Value: Set the default value for this parameter at the batch run level.
6. Click Override to save changes.

Allocating material inventory

1. From the relevant batch run, click Parameters.
2. Click Allocate Material Inventory. The following additional rows display beside each material parameter: Allocated Sublot, Allocated Quantity, Suggested/Required.
3. To add a new allocation, click more_horiz More Options > Add New Allocation.
4. Select or enter the information in the required fields:
   • Allocated Sublot: Select an appropriate sublot to allocate.
   • Suggested/Required: Select whether this allocation is suggested or required.
5. (OPTIONAL) Review the provided Allocated Quantity and update, if applicable.
6. Click Save.

Updating batch information and batch-run-specific configurations

1. From the relevant batch run, click Information.
2. Review available fields and settings and make any necessary modifications:
   • The following batch information fields described in Steps 8 & 9 of the Starting a new batch run section of this article can be updated or modified:
     • Start Date
     • End Date
     • Campaign
     • Location ID
     • Notes
   • The following batch-run-specific configurations can be modified:
     • Allow Batch Run Modification (disabled by default): If enabled, the user can mark a unit operation or procedure as N/A, modify parameter values on Not Started procedures, and insert new procedures.
     • Enable Redlining for All Procedures within This Batch (disabled by default): If enabled, operators may add something called a substep to an existing step during batch execution to indicate any additional steps or changes made by the operator during execution. (This can support experimental procedures in pre-clinical and clinical environments where the exact recipe may not be determined by the time of template creation.)
3. Click Save.

Assigning users for batch execution

1. From the relevant batch run, click Assign.
2. Search for or locate the relevant user's name, then click the checkbox to the right.
3. Click Save changes.

Adding documents and replacing placeholders

Adding a document

1. From the relevant batch run, click Documents.
2. Click Add Document.
3. Click Choose your file then select a PDF, DOCX, PNG, or JPG file from your computer.
4. Enter a Document Name following your organization's naming conventions.
5. (OPTIONAL) Select a Unit Operation Instance to associate this placeholder with a specific unit operation within this batch run. Then, optionally, select a Procedure Instance Title to associate this placeholder with a specific procedure within the unit operation.
6. Click Add Document.

Printing a batch run report

1. From the relevant batch run, click the Batch Run Report button near the upper right corner of the page. The Batch Run Report dialog opens with the checkbox for every tab selected by default.
2. Deselect the checkboxes for any tab names that you do not want to print, if applicable.
3. Click Print. The system generates a batch run report as a webpage. To print the webpage, click the print Print icon, then follow any additional instructions in the print dialogue.
4. Click close Close to dismiss the batch run report webpage.