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

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.

The enhanced certificate check, which displays related component details, has been improved to not only display the certificates of the related components, but also to display any related components without certificates. This feature helps you to identify any components missing a certificate when you are reviewing the details of an enhanced certificate check in the My Release Decisions app.

In the My Release Decisions app, when you are reviewing the related component details for an enhanced release check, you can click on the Batch ID of a particular component to navigate to the release decision item for that component. This new feature helps you to review the component data in detail, without having to search for the relevant release decision items manually.

This feature applies to the following types of release checks if you have configured them as enhanced release checks:

• Certificate Check
• Quality Control Data Check
• Change Control Check
• Deviation Check
• Batch Record Review

The display of components has been enhanced and you now have the following configuration options to help you visualize components efficiently:

• View components as a flat list or as a hierarchy
• Use quick filters to find issues more easily in the flat list
• Hide duplicates in the flat list

This new feature helps you to improve the user experience and enables an intuitive understanding of exceptions in the component check. The various visualization options help to reduce the time and effort required to review a large list of components.

In addition, in the Manage Release Configurations app, the Relevant Hierarchy Levels setting for the component check has been moved from General Settings → Settings for Release Checks to Configure Release Checks  → Release Checks. It is now included with the visualization settings for the component check, so that all the related settings are located together.

For more information, see: Configuring Release Checks.

If the release check type is Component Check, select the visualization settings. The following settings control how the component batches are listed in the Release Check Details in the My Release Decisions app:

The configuration of the component check has been enhanced to allow you to define quick filters for exceptions.

You can categorize the exceptions as Red or Yellow based on the values of specific attributes.

This feature helps you to spot the exceptions in the component check quickly and reduces the time and effort required to review a large list of components.

For more information, see: Configuring Release Checks.

If the release check type is Component Check and you are using the Flat List style of display, define your quick filters for exceptions.

You define exceptions and categorize them as either Red or Yellow. These quick filters are used to categorize the batch components in the Release Check Details in the My Release Decisions app. They can help you to identify exceptions quickly when there is a long list of batch components.

When you configure your release checks in the Manage Release Configurations app, you can enable an automatic reset of the release check status. 

Under Configure Release Checks → Release Checks, choose the specific release check (in this case on the example of Batch Record Review) and turn on the feature Automatic Reset of Release Check Status.

When you configure your release checks in the Manage Release Configurations app, you can enable an automatic reset of the release check status. Previously, this feature reset the release check status only when a user made manual changes to the release check data. With this release, the system also resets the release check status when new release check data is received via the API. Note that this automatic reset applies to release check statuses set by a user. If the status is set by the system, then the system reexecutes the relevant business rule and updates the release check status as appropriate.

This feature prevents possible inconsistencies where a manually set release check status no longer matches the most recently received release check data. It helps to ensure you have accurate release check statuses before making your release decisions.

For more information, see: Configuring Release Checks.

If you turn on this feature, the system automatically resets the release check status when new release check data is received from the source system or when a user changes the release check data. This automatic reset applies to release check statuses set by a user. If the status is set by the system, then the system reexecutes the relevant business rule and updates the release check status as appropriate. 

In the Edit Mode, you are able to either turn on or off Automatic Resets of Release Check Status in the release check.

When a manually set release check status is automatically reset due to data changes, a notification is sent to the following users:

• The user who set the release check status
• The user who is assigned to the release decision item

This notification informs the responsible users that new release check information is available, and that action is required. From the notification, you can navigate directly to the affected release check to review the updated data and set a new release check status if necessary.

For more information, see Configuring Release Checks.

The notifications are shown on the "bell symbol" on the top right-hand side.

In this example, the user has received a new notification. The notifications are shown on the "bell symbol" on the top right-hand side.

In the Manage Release Configurations app, you can configure your release checks to consider the related component details.

This feature is available for the following release check types:

• Deviation Check
• Quality Control Data Check
• Change Control Data Check
• Certificate Check

When this feature is enabled, the related component details are displayed on the release check details page in the My Release Decisions app.

To configure an enhanced release check, you need to make the following settings in the Manage Release Configurations app:

• Under Configure Release Checks →   Release Checks, turn on the Consideration of Component Data setting for the relevant release check.
• Under Configure Quality Departments → Material Types, define which material types are relevant for which enhanced release checks.

For more information, see Configuring Release Checks and Enhanced Release Checks.

The following pictures show the Quality Control Data Check and the Certificate Check, in which the Consideration of Component Data is enabled.

Here, all the different status values will be added that you determined based on the business rules execution. Be aware of the naming and the IDs of the release checks status so that the correct color coding can be determined. The status also indicated whether the release decision can be made with a specific release decision status. For example, if the release check status is CT Complaint then the check will be displayed as a green tick and the impact on the release would release without restrictions. You could also set a red status to release without restriction but if other release checks have a different setting then this will be overruled.

The list of assigned release types will be filled once the release check has been assigned to a 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.

In this activity, you configure the release types that are to be available for the creation of release decision items in the My Release Decisions app. 

Release types define the quality and compliance requirements that must be fulfilled before a batch can be released. In this activity, you specify which release checks must be completed and which release decisions can be set for release decision items of a specific release type. 

SAP delivers a set of preconfigured release types. You can use these preconfigured release types or create your own. 

The preconfigured content can be found under this link: Preconfigured Release Types

In the above screenshot you see all release types that are preconfigured.

1. In the toolbar of the Release Types table, choose Create. The detail view opens. 
2. Enter an ID and description and specify an activation status.
3. To use a release type, for example, in a release process flow, the release type must be active.
4. Add the release checks that must be completed for the release type and make settings as required.
5. Add the release decisions that can be set for the release type and make settings as required.
6. Optional: Specify subsequent release decisions if you want to allow reprocessing of a release decision item after a specific release decision was set. When you add a subsequent release decision, use the Auto-Create Item for Reprocessing setting to specify whether the system automatically creates a copy of an item for reprocessing when a release decision is set. 
7. Optional: Enter translations for the release type description.
8. Choose Create.

In the tabs Assigned Release Checks and Allowed Release Decisions the release type will be finalized. In the Release Checks tab all the relevant release checks will be assigned which need to be completed for a release of a batch. You can also create a release type without any release checks that could serve as an intermediate step in the batch release, or a work around if a second signature is requested.

The Release Decisions tabs contains all decisions that need to be assigned to a release type. It should also correspond with the release check status values.

For the reprocessing as subsequent release decision you can select one of the release decisions. In this example for approved with conditions, the subsequent decision would be approved and a new release item will be created. For the transfer to SAP S/4HANA the settings in QM for the inspections lot need to be taken into account and checked.

For details around the reprocessing: Enabling Reprocessing for a Release Type

The combined Release Type can be used if the SAP Batch Release Hub for Life Sciences has been set to release type determination based on inspection type. In the combined release type set up you can combine different release types in a sequence, so that for the inspection type determination a sequence flow could be also offered.

In this activity you just combine the different release types that you want to use in the intended sequence.

1. In the toolbar of the Release Types table, choose Create. The detail view opens. 
2. Enter an ID and description and specify an activation status.
3. To use a release type, for example, in a release process flow, the release type must be active.
4. Add the release checks that must be completed for the release type and make settings as required.
5. Add the release decisions that can be set for the release type and make settings as required.
6. Optional: Specify subsequent release decisions if you want to allow reprocessing of a release decision item after a specific release decision was set. When you add a subsequent release decision, use the Auto-Create Item for Reprocessing setting to specify whether the system automatically creates a copy of an item for reprocessing when a release decision is set. 
7. Optional: Enter translations for the release type description.
8. Choose Create.

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

Setting a release decision is the final step in the processing of an item in the worklist in the My Release Decisions app. Which release decisions can be set for an item depends on the release type. When configuring release types, you specify the release decisions that are allowed for a release type. 

You can map release decisions to usage decisions and quality batch statuses. Based on this mapping, the corresponding usage decision and quality batch status is set in the source system once a release decision is set in the My Release Decisions app. 

SAP delivers a set of preconfigured release decisions. You can use these preconfigured release decisions or create your own.  The preconfigured content can be found under this link: Preconfigured Release Decisions.

1. In the toolbar of the Release Decisions table, choose Create. The detail view opens.
2. Enter the required release decision details and specify an activation status.
3. To use a release decision, for example, when configuring release types, the release decision must be active.
4. Optional: Enter translations for the release decision description.
5. Choose Create.

 In this screen also the mapping of the release decision with the Quality Batch Status and the Usage Decision in ERP will be made. Those status values need to set up in SAP Batch Release Hub for Life Sciences as well.

In this activity all usage decision that will be mapped to the release decision needs to maintained. It is possible to replicate the Usage Decision Codes from SAP S/4HANA to SAP Batch Release Hub for Life Sciences with the outbound implementation LSCH_UDC with the replication model LSCH_BRH.

It is of course possible to create the Usage Decision Codes manually in the system.

SAP Batch Release Hub provides preconfigured Quality Batch Status Values for more information, please review this link: Preconfigured Quality Batch Statuses

If you already maintain custom specific values in SAP S/4HANA you would be able to replicate those into SAP Batch Release Hub for Life Sciences with the outbound implementation LSCH_QBS with the replication model LSCH_BRH.

The Quality Batch Status will be also shown in the component check view and will also lead to non-compliant component check if a specific status is be set for the component.

In lesson 3 unit 2 it will be explained how the set up of the stock posting types will be handled in SAP S/4HANA with the current IHLS Addon. (Integration Hub for Life Sciences)

The stock posting type total needs to be maintained on both side in SAP S/4HANA and SAP Batch Release Hub for Life Sciences. The stock positing type total enables that the tab stock posting is visible. You could leave the setting just with the total stock posting type and enable an automatic stock posting based on the Usage Decision code. But if you want to split the quantity into different stock posting types, then first the automatic stock posting needs to be disabled in SAP S/4HANA, and the setting posting types should be made available in SAP Batch Release Hub for Life Sciences, and in SAP S/4HANA.

If you are using a different ERP system besides SAP, the stock posting types in your ERP system might be called differently and need to be set up here as well.

Creating the Release Process Flow is not labeled as a configuration activity as this combines master data and configuration. It step determination of the release type select the release process flow, then this table needs to be maintained.

In the release process flow you can identify how a release type can be determined by using the following criteria:

• Location: Plant or Customer
• Procurement Type Internal: External or both (it is linked if it is procured or produced internally or externally)
• Material Type: Single value select out of the material type table
• Material Group: Will be maintained in the material master of the SAP ERP System
• Material: One single Material

The next steps explain the process flow, combining different release types.

In this tab you can assign the release types that should flow in a specific sequence. In the example, the first step is TRI - Technical Release for Internal Production and the second step would be MR - Market Release.

It would not be possible to release the Market Release (MR) before the Technical Release (TRI) as this needs to be completed first. If you are using an SAP ERP and create an Inspection lot in SAP Batch Release Hub for Life Sciences, it will be checked what process flow will be applicable. If this example flow will be selected then two different release items from the same release decision trigger (Inspection lot) will be created.

A flow could also contain only one release type.

If you have not selected Release Process Flow in the general settings then you need to proceed with the next section.

The first activity would be to replicate all relevant inspection types into SAP Batch Release Hub for Life Sciences, this could be done manually or via the SAP S/4HANA outbound implementation LSCH_INSTY. The details just lists the ID and the description of the inspection type.

In the next step we assign the inspection to a release type.

In the release process flow multiple release types could be assigned in sequences to one release process flow. In this method you assign one release type to one inspection type.

For example, in the case of an internal production you could assign the inspection type 04 to market release (MR) and the inspection type 03 (in process control) could be then assigned to the technical release (TRI). In this set up the release decision app will display two different release items as they are coming from two different inspection lots.

Also for this method you can use a sequenced process. If you are creating a combined release type, select combined instead of the single release type.