Configuring SAP Batch Release Hub for Life Sciences

SAP Batch Release Hub for Life Science introduces the concept of the Quality Department as the central unit for organizing and scheduling the release items and assigning the relevant authorizations within the Quality Department. 

For example, our company, SAP Pharma, has three plants and two distribution hubs. In addition to the finished product, the company produces a drug substance that will be sold to other companies.

The following graphic displays how SAP Pharma has organized the quality departments.

As the above graphic illustrates, we would assign two quality departments to the Walldorf plant and a single quality department to each Palo Alto plant and the Plano Distribution Hub. One approach could be creating quality departments based on plants and distribution hubs. Another option is to create a quality department based on the material type or products used across the plants. As in the example, both drug substances belong to the same quality department.

The plants are identified as locations in the quality department, and assigning customers as locations would also be possible.

In the configuration of the quality departments, you can narrow the localization by organization area, such as drug substance production or the specific product line. The location type would be another characteristic of locations in the quality department, for example, a production plant like the Walldorf Plant or a distribution center like the Hamburg Distribution Hub.

Those characteristics must be set up once you want to start using SAP Batch Release Hub for Life Science. They must be set up in SAP S/4HANA & SAP Batch Release Hub for Life Science.

The key organizational unit in the SAP Batch Release Hub for Life Sciences is the Quality Department.  

With the Manage Quality Departments app, you can administer the locations, users, and responsibilities relevant to processing release decisions for batches in your organization. 

The app shows the quality departments you're responsible for, giving you an overview of each department's assigned users and locations. You can define quality departments to reflect the distribution of locations and responsibilities in your supply chain.

Here's what you can do in this app: 

• Assign locations to a quality department using plants or customers relevant to the processing of release decisions. 
• Add users to a quality department and assign a business role to each user. 
• Create responsibilities for the users and locations assigned to the quality department. The user responsibilities determine which release decision items appear in each user's worklist in the My Release Decisions app. 

The next step is assigning a user to the quality department.

The user can have the following predefined Business Roles:

• Release Decision (Release Responsible Person)
• Sets the release decision (release-responsible person)
• Release Preparation (Quality Analyst (QA))
• Completes preparatory work before the release decision is set (quality analyst)
• Release Review (Business Manager)
• Reviews information in the release decision process, without authorization to make manual changes

A user could have different roles in different quality departments. If we are to think back to our example from the beginning of this lesson: An employee of plant Walldorf could have the Release Decision Role for Quality Department 0023 and the Release Preparation Role for Quality Department 0001. As this employee also checks the release in the DC Plano, they could also be assigned to the Quality Department 0075.

The set up is the most important step of configuring the SAP Batch Release Hub for Life Science implementation, as it also influences the authorization for viewing, changing and releasing the items in SAP Batch Release Hub for Life Science.

As mentioned, the location is assigned to the quality department. A location could be a plant transferred from ERP (SAP ERP Central Component or SAP S/4HANA) and a customer.

The characteristics like organization area and location type will be set up in the general configuration section of this lesson. You can use those characteristics to make the quality department more granular. They are optional fields, but it should be kept in mind that you cannot add those characteristics once you are using the SAP Batch Release Hub for Life Sciences.

All users assigned to a quality department can now be assigned to different locations, either a plant or a customer. If we go back to the example from the beginning of the lesson, the quality department 0023 includes the plant Walldorf and the plant Bangalore. Different users could work in those two plants.

In this example, we have assigned four users to our quality department:

• Theo Walldorf
• Sabine Sankt Leon
• Mandar Delhi
• John Berlin

All users have the business role "Release Responsible Person".

For the location Plant Walldorf, we assign the following user responsibilities:

• Theo Walldorf
• Sabine Sankt Leon
• John Berlin

and for the location Plant Bangalore:

• Mandar Delhi
• John Berlin

John Berlin has been assigned to both plants, but we could narrow his responsibility by assigning a specific release type, material, or material group for Plant Bangalore. This would prevent him from executing all the release decisions in the Plant Bangalore. 

The configuration approach shall integrate the different sources where the data is delivered into SAP Batch Release Hub for Life Science. In the graphic you see that the different objects can be updated within the configuration.

For the ERP System you get data such as materials and plants. In the configuration, you are able to distinguish the different release processes for different material types and plants. Also, the mapping of the release status from SAP Batch Release Hub for Life Science to the status that will be set in the SAP ERP system will be done in the configuration of the SAP Batch Release Hub for Life Science.

The configuration of a batch release hub is divided into two parts:

• Generic configuration

  How shall the batch release process look like in SAP Batch Release Hub, does the customer need different release types for the different materials, what is the mapping of status values against the release decision status values of the ERP back-end systems.

  Those questions can be configuration custom specific in the SAP Batch Release Hub for Life Science configuration app.

• Business Rules

  The business rules include the logic, if the incoming data will be set to a specific value. For example, what status sets the Batch Record Review Check to complete with a green tick. The business rule includes status values that will be sent to the source system. SAP will deliver the business rules as preconfigured content, but it could be copied for customer adoption. Module 2 Unit 2 Lesson 7 describes the possibilities of the rule engine.

All those activities lead to an individualized worklist for the qualified person and the quality teams.

In this Manage Release Configurations app, you make basic settings. For example, how the release types relevant for a batch are determined for creating release decision items. Batch Release Hub provides a preconfigured content. 

The release type determination method controls how the release types relevant to a batch are determined. The corresponding release decision items are created in the My Release Decisions app based on the release types. 

You also specified a repository for document management for this activity. A repository is required to upload and download attachments and view certificates in the My Release Decisions app. 

If you want to use the preconfigured content provided by SAP, you can trigger the import of this content to pre-fill the relevant configuration activities. 

With the current release, only the English language is supported. The other master languages will be released in the future.

Master Languages are:

• English
• French
• German
• Simple Chinese
• Spanish
• Portuguese
• Russian
• Japanese

Within the Manage Release Configurations , you configure the business roles that are relevant to the processing of release decisions in your organization. 

After configuring them here, you can assign business roles to users in quality departments. Business roles determine the release activities that a user is authorized to perform when working in the My Release Decisions app. 

SAP delivers a set of preconfigured business roles:

• QA: Quality Analyst
• BM: Business Manager
• RRP: Release Responsible Person

You can use these preconfigured business roles or create your own.  You can only assign the standard release activities:

• Release Preparation
• Release Review
• Release Decision

In the toolbar of the Business Roles table, choose Create. The detail view opens. Enter the required details and specify an activation status. 

To use a business role when defining users in the Manage Quality Departments app, the role must be active. 

Specify a release activity for the business role. This setting determines what a user can do when working on release decision items in their worklist. For example, a user who is authorized for release review can display release decision items and details but can't make any changes. Optional: Enter translations for the business role description.

Choose Create. 

Within the Manage Release Configurations you can also configure location types that are relevant for release decision processing in your organization. 

You can use location types when defining locations in a quality department. The location type is an optional attribute that provides additional information about the characteristics of a location, for example, whether it's a distribution center or a warehouse. 

You can enter location types manually. Push the create button and follow the next screenshot.

In the toolbar of the Location Types table, choose Create.

The detail view opens. Enter the required details and specify an activation status. To use a location type, for example, in a quality department, the location type must be active. Optional: Enter translations for the location type description.

Choose Create. 

Within the Manage Release Configurations app, you also configure organizational areas that are relevant for release decision processing in your organization. 

Optionally, you can use organizational areas to structure locations in quality departments. Organizational areas enable you to distinguish between activities at the same location, such as production areas, storage locations, or work centers. In a quality department, you can then assign user responsibilities at the level of the defined organizational areas. 

Choose the create button and follow the next screenshot.

In the toolbar of the Organizational Areas table, choose Create. The detail view opens. Enter the required details and specify an activation status. To use an organizational area for a location, the organizational area must be active. Optional: Enter translations for the organizational area description.

Choose Create. 

In this activity, you configure material types that are relevant for the processing of release decisions in your organization.

You can use material types for the following:

• Definition of responsibilities for users in a quality department
• Determination of release types using release process flows or inspection type assignments

You can enter material types manually or import them from your source system. If you import the material types from your source system, don't make additional settings in this activity. When creating material types manually, the IDs and descriptions entered here must be identical with the material types defined in your source system.

For the replication from SAP S/4HANA you can use the outbound implementation LSCH_PRDTY in the replication model LSCH_SAP Batch Release Hub for Life Science.

1. In the toolbar of the Material Types table, choose Create.
2. The detail view opens.
3. Enter the required details and specify an activation status.
4. To use a material type, for example, in release process flows or inspection type assignments for release types, it must be active.
5. Optional: Enter translations for the material type description.
6. Choose Create.

1. In the Material Types table, select the row for the material type that you want to change.
2. In the header area of the detail view, choose Edit.
3. Make entries as required.
4. Choose Save.

General settings changes can be made using the Make General Settings option. The first step is Release Type Determination.

SAP Batch Release Hub for Life Science comes with preconfigured content. In this activity you can delete and re-import the rules. For more information on what will be delivered as preconfigured content check: Preconfigured Content

Using this app, you can set up and configure the processing of release decisions for batches in the My Release Decisions app.

Within the Manage Release Configurations, you configure the business roles that are relevant to the processing of release decisions in your organization. 

After configuring them here, you can assign business roles to users in quality departments. Business roles determine the release activities that a user is authorized to perform when working in the My Release Decisions app. 

SAP delivers a set of preconfigured business roles:

• QA: Quality Analyst
• BM: Business Manager
• RRP: Release Responsible Person

You can use these preconfigured business roles or create your own.  You can only assign the standard release activities:

• Release Preparation
• Release Review
• Release Decision

Within this app, you can view and configure the responsibilities that have been assigned to the users in your quality departments.

Defining user responsibility templates helps you to assign and manage user responsibilities efficiently.

The scope of a responsibility is defined in terms of Release Type, Material Type, and Material Group. For each of these elements, you have the option to specify All or one or more specific elements.

When you have defined your user responsibility templates, you can assign them to users in theManage Quality Departments app. The user's assigned responsibilities determine which release decision items the user sees in the My Release Decisions app.

In the next figure, you can see another example how to configure User Responsibility Templates.

In the toolbar of the Business Roles table , chooseCreate. The detail view opens. Enter the required details and specify an activation status.

To use a business role when defining users in the Manage Quality Departments app,the role must be active.

Within the Manage Release Configurations you can also configure location types that are relevant for release decision processing in your organization. 

You can use location types when defining locations in a quality department. The location type is an optional attribute that provides additional information about the characteristics of a location, for example, whether it's a distribution center or a warehouse. 

You can enter location types manually. Push the create button and follow the next screenshot.

In the toolbar of the Location Types table, choose Create.

The detail view opens. Enter the required details and specify an activation status. To use a location type, for example, in a quality department, the location type must be active. Optional: Enter translations for the location type description.

Choose Create. 

Within the Manage Release Configurations app, you also configure organizational areas that are relevant for release decision processing in your organization. 

Optionally, you can use organizational areas to structure locations in quality departments. Organizational areas enable you to distinguish between activities at the same location, such as production areas, storage locations, or work centers. In a quality department, you can then assign user responsibilities at the level of the defined organizational areas. 

Choose the create button and follow the next screenshot.

In the toolbar of the Organizational Areas table, choose Create. The detail view opens. Enter the required details and specify an activation status. To use an organizational area for a location, the organizational area must be active. Optional: Enter translations for the organizational area description.

Choose Create. 

In this activity, you configure material types that are relevant for the processing of release decisions in your organization.

You can use material types for the following:

• Definition of responsibilities for users in a quality department
• Determination of release types using release process flows or inspection type assignments

You can enter material types manually or import them from your source system. If you import the material types from your source system, don't make additional settings in this activity. When creating material types manually, the IDs and descriptions entered here must be identical with the material types defined in your source system.

For the replication from SAP S/4HANA you can use the outbound implementation LSCH_PRDTY in the replication model LSCH_SAP Batch Release Hub for Life Science.

1. In the toolbar of the Material Types table, choose Create.
2. The detail view opens.
3. Enter the required details and specify an activation status.
4. To use a material type, for example, in release process flows or inspection type assignments for release types, it must be active.
5. Optional: Enter translations for the material type description.
6. Choose Create.

1. In the Material Types table, select the row for the material type that you want to change.
2. In the header area of the detail view, choose Edit.
3. Make entries as required.
4. Choose Save.

General settings changes can be made using the Make General Settings option. The first step is Release Type Determination.

SAP Batch Release Hub for Life Science comes with preconfigured content. In this activity you can delete and re-import the rules. For more information on what will be delivered as preconfigured content check: Preconfigured Content

With the predefined content, SAP delivers with the following release checks except the custom check, as this is a check that can be individually custom defined.

All release checks include the standard business rules assigned to the release checks. The customer would be able to create custom specific checks based on the standard content.

As one of the first activities to create a new release check, you can check if the preconfigured status values would fit to the data that will be sent from the source system. This screenshot above displays all the preconfigured release check status. Please see the link for details: Preconfigured Release Check Statuses

The status will be used in the release check set up to identify what color coding will be set on this status, and what the impact of the overall release decision the status is causing. In the next screenshot we created the release check message.

For the preconfigured business rules and release checks, SAP Batch Relese Hub for Life Sciences is also providing the corresponding Release Check Messages for the release checks. More details can be found under: Preconfigured Release Check Messages

It would be also possible to create customer release check message or reuse the standard once.

In the case of the certificate check, three messages have been created. These messages IDs will be assigned to the respective business rules for this release check. The next step combines the status and the messages in the creation of the Release Check.

In the configuration app, the Configure Release Checks option includes all activities to create and change release checks. Please be aware that you should not change the standard setting as they might be overwritten with the new releases.

In this activity, you configure the release checks that are to be available for assignment to release types.

Release checks evaluate certain quality aspects of a batch to determine whether any defects or anomalies exist that require further action before a batch can be released.

To determine which release checks are relevant for a release decision item in the My Release Decisions app, you assign release checks to release types.

SAP delivers a set of preconfigured release checks. You can use the preconfigured release checks or create your own release checks.

• Annual Product Quality Review (APQR) Check

  Checks the availability of an annual product quality review (APQR) report for the combination of material and location for the batch.

• Artwork and Safety Label Check

  Provides information about the compliance of artwork and safety labels for a batch.

• Batch Genealogy Check

  Checks the availability of genealogy data for the batch.

• Batch Record Review

  Evaluates the batch (master) record and determines whether the batch complies with regulations.

• Certificate Check

  Checks the availability of certificates for a batch.

• Change Control Data Check

  Evaluates change records for a batch and ascertains whether any change records are open or on hold.

• Clinical Trial Regulatory Check

  Checks the health authority approval and approved shelf life for clinical trial batches.

• Clinical Trial Technical Check

  Evaluates the status of the clinical trial technical check as imported from your source system.

• Component Check

  Evaluates the component batches used in the production of a batch.

• Deviation Check

  Checks the status of any deviations associated with a batch.

• Quality Control Data Check

  Evaluates characteristics that are relevant for compliance with quality specifications during the manufacturing process.

• Regulatory Data Check

  Evaluates the status of relevant regulatory information for a batch.

• Serialization Data Check

  Evaluates attributes that apply for batches that are relevant for serialization.

  Temperature Check

  Displays attributes that are evaluated to ensure adherence to the required temperature conditions for a batch.

• Transport Check

  Displays attributes that are evaluated when a batch is transported from one location to another.

In this link you find more information on the preconfigured / predefined release checks that will be delivered and updated by SAP Batch Release Hub for Life Sciences:Preconfigured Release Checks

1. In the toolbar of the Release Checks table (Previous Screenshot), choose Create. The detail view opens.
2.  Enter the required release check details and specify an activation status. 
3. To use a release check, for example, in the configuration of release types, it must be active. 
4. Add the allowed release check statuses and make settings as required. 
   Note

   The status values that you add for the regulatory data check are also used for the valuation of attributes in the My Release Decisions app. 
5. Optional: Enter translations for the release check description.
6. Choose Create. 

The manual release check can be used for all checks where no data for a source system will be sent. This can be created to integrate a manual checklist that sometimes can be found in customer set ups.

A manual check could be for example, a check for existence for specific document or label where there is no system to record the data. It could also be used for checks where currently no API for the check is available, for example Data from Global Trade System (GTS) or Environment Health and Safety (EHS).

As can be seen in the screenshot, there is no business rule behind the release check.

For a manual release check, only a User can set the status.,The other options of System and System/User are not possible.

In this tab of the manual release check creation, you can assign the different status values that shall be available to be set for the manual check. The color coding is linked to the status of the other release checks.

It also indicates how the status shall influence the release decision. For example, if the check is on hold you can only release with a mandatory comment, or for No Compliant only rejection is only possible.

The assignment of the release types will be done once the release check is used in a release type. Initially, this table is empty. In our example, the manual release check is only used in one release type.

This list will be generated once the release check has been assigned to a release type. The creation of a release type be covered in the next pages.

The checklist will be created by using the Checklist Items tab. You can create multiple steps for the checklist and assign a condition for the acceptance. In the next screenshot you will see the details for Step 1 which includes the results of the conditions for acceptance for "Tax Papers".

In the table Allowed Results, you can enter all the values required to complete this release check.

As listed, SAP Batch Release Hub for Life Science provides preconfigured release checks. If the customer wants to change a standard release check it is recommend to create custom copies of the standard release checks.

The mandatory fields are always marked with a red asterisk. The field for the Release Check ID has a maximum length of 10 characteristics.

By creating a new release check you need to assign a release check type, this would indicate if it is:

• a custom release check as described in the previous slides, where there is no source system sending data or
• a release check that is based on standard content where data form other source systems will be expected. The current available release check types are: APQR Check, Artwork and Safety Label Check, Batch Record Review, Certificate Check, Change Control Data Check, Component Check, Clinical Trial Check, Deviation Check, Genealogy Check, Quality Control Data Check, Regulatory Data Check, Serialization Data Check, Transport Check and Temperature Check

Release Check Status Determination identifies whether the check can be set by the system only, a combination of system and user, or only by a user. In case of the release checks that will be linked to a business rule, the status shall be set either by system or system and user.

You can assign standard business rules to the release check, or select custom created business rules that you have created. The business rules allow us to set the status automatically based on the status values and data that have been entered in the business rules, for example what status will be expected from the source system to set the release check to be compliant.

In SAP S/4HANA for example, there is a status mapping table which will be sent to SAP Batch Release Hub for Life Sciences in case of sending the QC data into SAP Batch Release Hub for Life Sciences.