Assessing Apps Used by Authorized Person and by Inspectors

SAP Batch Release Hub aims to speed up the batch release process in the Life Sciences industry. As an Industry Cloud solution, it replaces the paper-based batch release process with an all-in-one digital tool that streamlines, automates, and simplifies it. The hub automatically consolidates batch release check status from different source systems and visualizes it into one single worklist with varying levels of information to enable a zero-time batch release.

SAP Batch Release Hub is an advanced solution that addresses the specific needs of quality management and operational excellence for batch release.

This process starts with configuring the tool, including the quality department's organization, access rights, and release configuration.

The qualified person or the release responsible person can access and review the batch worklist items while waiting for the usage decision. Based on the automatic evaluation of release check compliance status, you can decide on the final disposition per stock type and country and confirm the decision with an electronic signature.

1. Configure SAP Batch Release Hub for Life Sciences: The Quality Manager, together with IT, performs the initial configuration for the quality department and release configurations during the solution's implementation.
2. Check Worklist Items: The Qualified Person can access the worklist items and see all assigned batches based on her access rights. She also sees a user-friendly summary of each batch's compliance status on this view.
3. Review Release Checks: She can then select one batch and review the details of release checks like regulatory checks, components checks, deviation check, certificate check, artwork (labeling) check, and so on. She can finally decide on the final usage decision per quantity and country based on the assessment for the release check summary.
4. Confirm Usage Decision: When the analysis is completed, the Qualified Person can select the final usage decision from the available drop-down menu and confirm the decision with an electronic signature.

The ​Release Decision Overview​ app provides a comprehensive summary and possibility to drill down to details to facilitate the the analysis of what needs to be processed.

For instance, by clicking on the Release Decisions that are on time, one can see which are still on time from the overview page and might then decide to proceed with them.

Clicking on the Item requiring my intervention, we then get selected those release decisions item that needs a manual release check still pending as shown above.

The Release Decision Overview dashboard contains several pre-built perspectives on the status of release decision items, however all of those representations are based on the same data, and drive to the same core application that is the My Release Decision.

Release Decision is the core App for the Qualified Person, since through this App the batch release decision has to be taken.

By clicking the Set Release Decision the Qualified Person is in-fact approving or rejecting the release of the batch.

Everything else in the app contains information of the various information that the Qualified Person must view into

All the information for the decision is contained in the same page. However, the tabs on the top of the page facilitate to focus directly on the required content.

The Release Checks is certainly the most important part of the app since it shows the status of the checks that has been configured for the specific release type.

In your worklist in the My Release Decisions app, if any release decision items have a pending business rule execution, they are highlighted by an icon displayed next to the Release Checks column. In addition, in the Release Check Summary on the release decision item details page, an icon is displayed next to the release check for which the business rule execution is pending, and a message strip informs you about the pending business rule execution. 

This feature ensures that responsible users are aware that the business rule execution is pending, and therefore the release check status might not match the most recently received release check data. It helps you to avoid setting a release decision for a batch without having the latest information.

This means that when the system sets the status of the corresponding release checks, it considers the release check data of the related component batches. For example, if a component has a deviation, it is reflected in the status of the deviation check for the parent batch. This ensures you have an accurate overall status for each release check, without having to review the individual components separately.

Previous lessons show how to configure SAP Batch Release Hub so that for specific batch release types also specific checks are performed.

In the Release Decision app, one sees the status of those checks and can further drill down to additional details.

For example, let's consider the Certificate Check. As shown above, is set for Completed. However, the Qualified Person wants to verify that.

By choosing the certificate check, the system shows you the details for the specific certificate check for the specific batch.

In the above screenshot, we see that indeed there is a certificate, with a specific certificate ID and also a link to the certificate.

The location of certificate storage is configurable, and by clicking on that icon, one views the certificate.

In version 2306 of SAP Batch Release Hub for Life Sciences, there are four possible actions that the Qualified Person can take within the SAP Batch Release Hub for a specific release decision, and these are shown in the top right part of the application.

1. Set Release decision
2. Set Prioritized Due Date
3. Assign
4. Set to canceled

For each of those actions, there is contextualized help. By choosing the question mark on the top bar, the help buttons are visualized.

By choosing, for example, on the question mark button close to the Set Release Decision button, then extensive help is provided.

The application is undergoing continuous updates and improvements, and therefore it is recommended to acquaint with the application as available and extensively rely on the context-sensitive help as shown above.

For compliance with GXP regulations, it is essential that a detailed history be available for those objects in the system that have a high level of compliance required.

This is achieved in SAP Batch Release Hub for Life Sciences through the Change History app.

In the screen above, we see when a specific Release Decision Item has been created, when and by whom, and then as data continues to come in the system the status of the checks, with old value and new value.

When changes are performed by people, than the person doing the change is appropriately logged.

In the example above, the Release Decision Item has been created automatically (Release Decision Item).

In the My Release Decisions app, you can create a comprehensive PDF report for an individual release decision. The release decision report includes all the information relating to the release decision, such as:

• Batch data
• Release check details
• Comments
• Attachments
• Countries
• Stock postings
• Release decision information

This report can be printed and shared with regulatory authorities or other parties as necessary.

The Qualified Person must be sure that the data is updated properly. You can check that this is the case by inspecting the apps in the Data Monitoring tab.

This tab contains a growing number of applications that facilitate the understanding of what is happening in the database.

1. Manage Staging and Active Data
2. Monitor Data Processing
3. Monitor Alerts

The first step in the data flow is that it first gets delivered to the Staging and Active data.

When the data is in the system, then the data is processed (Monitor data processing). Finally, if there are alerts this can be observed in the Monitor Alerts app.

When you launch Manage Staging and Active Data, there are no specific item types selected (left column, none type of item is selected).

Then, if you then execute a search, you will not get any results. The reason for this is that no object types are defined.

However, if you select a specific item type as shown below (Batches - Active), then the following happens:

1. You will see a set of data
2. You will be able to search for that data

As you can see, by selecting Batches - Active, the user interface automatically shows a subset of active batch records.

A Release Decision Item is a combination of batch, material, location, release type, and release decision trigger that represents a release decision to be made in the My Release Decisions app, Release Decision Item | SAP Help Portal.

Therefore, intoformation is present, one has to do the following:

1. Get the information for the Batch, using the following:
   • Batch ID = 0023240007
   • Plant ID = 1710
   • Material ID = MZ-LS-3002
   At the same time, verify if in the "source system" the data is the same, and also if the timestamp is identical.
2. Get the information from the Release Decision Trigger. We have previously seen that the trigger for the release decision was the creation of the Release Decision Trigger "010023240053". Therefore, we need to see the information that it carries with it.
3. The Inspection Lot corresponding for that release decision trigger will contain important.

Here we can see that the Batch data for this material has been delivered from a source system called "S4LCCNT300", at specific time. The "Source Modified On" is the timestamp as it comes from the source system.

In this case, the Source system is an SAP S/4HANA system in which we can log in and verify if there is corresponding data.

The "Activated On" is the timestamp of when (according to the SAP BTP timing) the data has been acknowledged in the "Active" stage of Batch Release Hub for Life Sciences.

The information about the release decision trigger as it has been generated from the Source System S4LCLNT300 is shown previously and as well as the Batch information is available in the Active monitoring data.

From this page we also see the Inspection Lot. An Inspection Lot is a request to a location to carry out a quality inspection for a specific quantity of a specific material, Glossary | SAP Help Portal.

The checks that are required to be completed to release the specific batch are specified in the type of inspection, and that is provided by the Inspection Lot data.

Now that we have the Inspection Lot information, we know that this Inspection Lot is of type "01" and we can see the checks that are needed.

These are specified in the configuration page.

This screen in the figure, Inspection Type - Release Type, shows you that Inspection type ID = 01 means "Goods Receipt, Insp for Purchase Order", and that the Release Type is "TR-IHLS".

Therefore, we could expect that in SAP S/4HANA, a purchase order was created and that triggered the need of a release of a batch, for which the quality inspection is required.

We can now proceed to see which are the required checks, by inspecting the following.

Here we see that for the TR-IHLS, the following checks are needed:

• Manual Release Check
• Deviation Check
• Change Control Data Check
• Temperature Check
• Certificate Check
• Transport Check

We can now manually investigate if that data has indeed been delivered and has the appropriate values.

• Manual Release Check
• Deviation Check: For the Deviation check we need to see if there is any deviation in the system: none
• Change Control Data Check
• Temperature Check: For the Temperature check, we see that the source system delivered a positive result for the completion of the temperature check and therefore the batch is okay from that point of view
• Certificate Check: The Certificate check returned a positive status, and as well we see that there is a certificate deposited and accessible through a Certificate URL
• Transport Check

At this point, we have verified that indeed what is contained in the summary screen was correct, and we can proceed with the manual check and then releasing the batch.

The audit rights are specified in the SAP Quality Requirement Schedule and are granted solely if the customer has subscribed the corresponding offer.

To fulfill those requirements, SAP Batch Release Hub for Life Sciences provides some specific applications that are here described and addresses the needs for the following:

• Provide evidence about the changes in the data (data integrity)
• Provide evidence about the approvals or rejection signatures that have been done with the system (electronic signature)

A true process flow for the Inspector is hardly standardizable, since Inspectors are free to analyze and require additional details according to their skill set and procedures.

It is to be expected that in addition to what we are shown above for the Qualified Person, that the Inspector is also going to verify the signature logs. This is provided through the following app.

Through the Change History app, you can see all changes that have been introduced in all objects.

SAP Batch Release Hub for Life Sciences uses the Personal Data Manager service. For more information, see SAP Personal Data Manager.

• With the Personal Data Manager, you can discover where personal data on a specific individual is shown in an application.
• Request deletion of personal data.

The following data subject roles are used in SAP Batch Release Hub for Life Sciences applications:

• Change Log User - ChangeLogUser
• External Contact - ExtContact
• Internal Contact - IntContact

A change log user is someone who is able to create and edit data in applications and whose actions are recorded in a change log.

The main purpose of Batch Release Hub for Life Sciences is to enable the execution of efficient decisions. These decisions are important to regulatory matters and therefore a specific logging function is available here.

Audit Logging is a capability provided Audit Log.

The Audit Log interface allows administrators to examine audit events.

• The system records audit events in the customer subaccount for the following types: Personal Data Changes. For more information, see Personal Data Manager
• Configuration Changes
• Security Events

Administrators can request audit logs for the desired category and time range. Depending on the size of the logs, their assembly can take up to several seconds. When a requested log is available, an administrator can download it from the request history list.

In the screenshots from the following figures, we can see that the audit log was properly recorded - the export of personal data that we demonstrated in the previous section.

Such activity would not be visible under the Change Log since it is not "properly" a change in the data of SAP Batch Release Hub for Life Sciences.

In these screenshots, one can see an example on how the different Change History and Audit Log viewers provide complementary information.

In this specific case, a manual change has been introduced for a release check, namely the detail was set to "okay" and that was recorded both in the audit log and in the change history logs.

Batch Release Hub for Life Science has a rich set of capabilities that enables the Authorized Person to efficiently set the release decision with full access to all the required data - as defined by the customer release process.

Batch Release Hub for Life Sciences provides detailed logging for all data changes that could have an impact on product quality or patient safety, and enables inspections to be performed efficiently at the highest level of detail.