Performing a Clinical Release Based on Package Control Number (PCN)

Objective

After completing this lesson, you will be able to perform the PCN release

PCN Release

The My Packaging Control Number Release Decisions app helps to streamline the process to group finished material batches that belong together in terms of blinding by allowing you to manage, review, and set release decisions at packaging control number (PCN) level, rather than for each individual batch.

Screenshot of SAP interface displaying the main dashboard for Release Decisions. The top menu includes tabs for Release Decisions, PCN Release Decisions, Jurisdictional Control, Data Monitoring, Configuration and Responsibilities, and Tracking of Changes. Below are various sections with tiles: 1. Release Decision Overview: Icon and text indicating a general overview. 2. My Release Decisions: Shows 21 open decisions. 3. My Release Register: Indicates where to access the register. 4. PCN Release Decisions: My PCN Release Decisions showing 159 decisions. 5. Jurisdictional Control: View Authorized Supply Chain Maps with an icon and text. 6. Data Monitoring: Contains tiles for Monitor Data Processing, Monitor Alerts, and Manage Staging and Active Data. 7. Configuration and Responsibilities: Includes tiles for Manage Release Configurations, Manage Quality Departments, View User Responsibilities, Manage Business Rules, Manage Repositories, and Transport Configuration Settings.

Upon clicking the "My PCN Release Decisions" app you are presented with a worklist of PCN release decision items. You only see the items that fall within your responsibility in the quality departments to which you are assigned.

Each PCN release decision item in your worklist has a number of batch-level release decision items (one for each assigned batch).

You can see the total number of batches assigned to the PCN and the number of those batches that have a release decision item in the Number of Batches with Release Decision Item column in your worklist.

Release checks are performed for each assigned batch and an aggregated release check status is calculated for the PCN. You can see a summary of the release checks and their aggregated statuses in the Release Checks column in your worklist.

Screenshot of SAP interface for My PCN Release Decisions. The top section displays search and filter options for PCN Release Decisions, including input fields for PCN, PCN Version, Study, Protocol ID, PCN Release Type, PCN Location, PCN Stock Transport Order, PCN Processing Status, PCN Release Decision, PCN Release Decision Set On, Due Date, Organizational Area, Supplying Location, Quality Department, and Batch Order. Below the search section is a table titled PCN Release Decisions (159) displaying detailed information for each decision. The table includes columns for PCN, PCN Version, Study, Protocol ID, PCN Release Type, PCN Location, Quality Department, Number of Batches with Release Decision Item, Batch Order, Release Checks, Organizational Area, Supplying Location, PCN Stock Transport Order, PCN Processing Status, PCN Release Decision, PCN Release Decision Set On, and Due Date. Entries include details such as various PCN IDs, PCN versions, study IDs, protocol IDs, release types (for example, Technical Release, Market Release), locations, quality departments, batch orders, number of release checks completed, organizational and supplying areas, processing status (for example, In Progress, New), release decisions, and set dates. Example dates indicate February and November 2024 and June 2024.

Various filter options are presented you at the top of the screen. In this example, a PCN ID filter was set.

SAP PCN Release Decisions interface. The interface displays a header with filters for PCN, PCN Version, Study, Protocol ID, PCN Release Type, PCN Location, Organizational Area, Supplying Location, Quality Department, and Batch Order filters. Below the filters, there is a list summarizing PCN release decisions. Columns include PCN, PCN Version, Study, Protocol ID, PCN Release Type, PCN Location, Quality Department, Number of Batches with Release Decision Item, Batch Order, Release Checks, Organizational Area, Supplying Location, PCN Stock Transport Order, PCN Processing Status, PCN Release Decision, PCN Release Decision Set On, and Due Date. The table displays details of 20 records. The records show different PCN versions, studies, protocols, release types, locations, quality departments, batches, batch orders, release checks, organizational areas, supply locations, stock transport orders, processing statuses, release decisions, decision dates, and due dates. A search bar and navigation buttons are also visible.

Upon clicking on a PCN release decision item from the worklist presented to you, the detailed overview for that item will be displayed. Here you are first presented with the header section containing basic information at a glance, including:

  • The PCN release decision (e.g. Rejected, Approved, Expired etc.). A "-" indicates that no decision has been set yet.
  • A graphic of the current release check status aggregated for each batch.
  • The general data for the PCN Release Decision Item

The rest of the PCN release decision item overview is compromised of detailed data:

  • PCN Detail
  • PCN Release Check Summary
  • Assigned Batches
  • Countries/Regions
  • PCN Release Decision
  • Attachments

You are able to jump to each section by clicking the respective header item.

SAP PCN Release Decisions interface for a Technical Release (ZTRI). The page includes details like PCN number PCN280601, Version V11, PCN Location CH32 test (CH32), Quality Department QQ (qq), and others. Due Date is Nov 30, 2024, Processing Status is New, and Business Rule Status is Inactive. The interface has tabs for PCN Details, PCN Release Check Summary, Assigned Batches, Countries/Regions, PCN Release Decision, and Attachments. Notifications show the business rule is inactive. General Data includes PCN number and location, version, organizational area, supply location, study data, and more. PCN Release Check Summary lists descriptions such as Batch Record Review (Not Completed), Change Control Data Check (On Hold), and other checks. Assigned Batches section lists details about each batch, including ID, Material ID, Description, Kit Type, Status, Release Quantity, Sequence Number Range, Protocol ID, Trigger ID, Trigger Type, Deviations, Release Checks, and Due Date. Buttons for setting PCN release decisions, activating business rules, and viewing change history are visible.

The PCN Release Check Summary present you with a list of relevant release checks for your selected PCN release decision item. The relevant release checks are listed under the "Release Check Description" column.

That status column aggregates the release checks of every assigned batch for your PCN release decision item.

How Are Release Check Statuses Aggregated?

The batches assigned to each PCN release decision item have the same set of release checks. The release checks are evaluated separately for each batch, so at a point in time, the batches could have different statuses for the same release check. SAP Batch Release Hub calculates the aggregated status of a particular release check by taking the most severe status for the assigned batches. For example, if there are 4 assigned batches, and the status of a particular release check is green for 4 batches and red for 1 batch, then the aggregated release check status is red.

The severity is applied in the following order:

  1. Red
  2. Yellow
  3. Gray
  4. Green
SAP PCN Release Decisions interface for a Technical Release (ZTRI). The page includes tabs for PCN Release Check Summary, Assigned Batches, Countries/Regions, PCN Release Decision, and Attachments. In the PCN Release Check Summary section, five checks are listed: Batch Record Review (Not Completed), Change Control Data Check (On Hold), Deviation Check (Not Relevant), Quality Control Data Check (Pending), and Regulatory Data Check (Not Compliant). Each check includes status set on April 26, 2024, by the system. The Assigned Batches section lists four batches with details such as Batch ID, Material ID, Material Description, Kit Type, Status, Release Quantity, Sequence Number Range, Protocol ID, Release Decision Trigger ID, Trigger Type, Deviations, Release Checks, and Due Date. All batches are marked as available. The Countries/Regions section lists five countries (Argentina, Canada, Switzerland, Germany, United States) with corresponding checkboxes to mark suitability for release. Suitable for all countries/regions by default.

Under the "Assigned Batches" section, you will find a list of all relevant Batch ID's, including additional information for the induvial batch like Material ID, Status, Release Decision Trigger ID, and the beforementioned release checks.

SAP PCN Release Decisions interface for a Technical Release (ZTRI). The page includes tabs for PCN Details, PCN Release Check Summary, Assigned Batches, Countries/Regions, PCN Release Decision, and Attachments. The PCN Release Check Summary section lists five checks: Batch Record Review (Not Completed), Change Control Data Check (On Hold), Deviation Check (Not Relevant), Quality Control Data Check (Pending), and Regulatory Data Check (Not Compliant). Each check includes status set on April 26, 2024, by the system. The Assigned Batches section lists four batches with details including Batch ID, Material ID, Material Description, Kit Type, Status, Release Quantity, Sequence Number Range, Protocol ID, Release Decision Trigger ID, Trigger Type, Deviations, Release Checks, and Due Date. All batches are marked as available. The Countries/Regions section lists five countries (Argentina, Canada, Switzerland, Germany, United States) with corresponding checkboxes to mark suitability for release. Suitable for all countries/regions by default. Buttons for setting PCN release decisions, activating business rules, and viewing change history are visible. The image background is in light color.

Once you click on the "Set PCN Release Decision" button, Batch Release Hub will notify you of any pending tasks or errors hindering you from setting a release decision. In this case, the suitability for the respective countries/regions was not set.

In order to fix this error, navigate to the bottom of the page, or click on the "Countries/Regions" tab.

SAP PCN Release Decisions interface for a Technical Release (ZTRI). The page includes tabs for PCN Details, PCN Release Check Summary, Assigned Batches, Countries/Regions, PCN Release Decision, and Attachments. The General Data section provides details such as PCN number PCN280601, Version V11, PCN Location CH32 test (CH32), Quality Department QQ (qq), Due Date Nov 30, 2024, Processing Status New, and Business Rule Status Active. The Study Data section includes details like Study CTS-123990, Protocol ID PROTOCOL-1, Blinding Group BLINDING-1, Sponsor SPONSOR-1, and Study Phase PHASE-1. In the PCN Release Check Summary section, five checks are listed: Batch Record Review (Not Completed), Change Control Data Check (On Hold), Deviation Check (Not Relevant), Quality Control Data Check (Pending), and Regulatory Data Check (Not Compliant), with statuses set on April 26, 2024, by the system. The Assigned Batches section lists four batches including details like Batch ID, Material ID, Material Description, Kit Type, Status, Release Quantity, Sequence Number Range, Protocol ID, Release Decision Trigger ID, Trigger Type, Deviations, Release Checks, and Due Date. All batches are marked as available. An error message popup says, Error: Please set the suitability for all countries/regions before setting a release decision. The Countries/Regions section is also visible listing five countries with checkboxes for release suitability. A Set PCN Release Decision button, a View Change History link, and an error message dialog with a Close button are visible on the screen.

Upon navigating to the "Countries/Regions" section of the screen, select each country by ticking the box in the far left side of the table, and then clicking on "Set Suitability".

A popup window will open with a drop down menu. Select either Yes or No, and click "Set".

SAP PCN Release Decisions interface for a Technical Release (ZTRI). The page includes tabs for PCN Details, PCN Release Check Summary, Assigned Batches, Countries/Regions, PCN Release Decision, and Attachments. The Countries/Regions section lists five countries (Argentina, Canada, Switzerland, Germany, United States) with checkboxes marked for suitability for release. A Set Suitability button is highlighted on the right, and a popup dialog titled Set Suitability is open. The dialog has a dropdown menu labeled Suitable with Yes selected, and buttons for Set and Cancel. Below is the PCN Release Decision section with general data fields for PCN Release Decision and Set On date, currently empty. The Batches section lists four batches with details including Batch ID, Material ID, Description, Release Decision Trigger ID, Trigger Type, Confirmed Quality Batch Status, Confirmed Usage Decision, and Confirmation Received On. No attachments are displayed. A Set PCN Release Decision button and a View Change History link are visible on the top right. The search bar, notifications, and user profile icons are also present. The background is light-colored.

Upon clicking on "Set PCN Release Decision", you will be presented with a new pop-up. Here you need to make your selection, provide a comment (if necessary), and enter the password of your Batch Release Hub account.

SAP PCN Release Decision screen for batch approval. Technical Release: ZTRI. Status: Batch Record Review not completed, Change Control Data Check on hold, Deviation Check not relevant, Quality Control Data Check pending, Regulatory Data Check not compliant. Assigned Batches: Four batches listed with IDs CFG_3888, CFG_3889, CFG_3890, CFG_3891, Material IDs CFG_0001 to CFG_0004, all available. Countries/Regions listed: Argentina, Canada, Switzerland, Germany, United States, all suitable. Set PCN Release Decision pop-up open, options to approve or reject, user Test2 Test2 to confirm with password.

Once you have set your release decision, the status will update in the header. In this case, the PCN release decision item was rejected, indicated by the "Rejected (RJ)" status.

Note

The status might take a few seconds to update. For this please refresh the page using the button in the top right section of the release decision item overview.

You are also able to view the change history for your current PCN release decision item by clicking "View Change History", found to the left of the refresh button.

SAP PCN Release Decision screen for batch approval. Technical Release: ZTRI. Release Decision: Rejected (RJ). Due Date: Nov 30, 2024. PCN Processing Status: Completed. Business Rule Status: Completed. General Data includes PCN, Version V11, Organizational Area, and PCN Stock Transport Order. Study Data includes Study ID CTS-123990, Blinding Group BLINDING-1, Sponsor SPONSOR-1, Protocol ID PROTOCOL-1, Study Phase PHASE-1, and PCN Expiry Date Jun 1, 2024. PCN Release Check Summary lists five checks with statuses: Batch Record Review not completed, Change Control Data Check on hold, Deviation Check not relevant, Quality Control Data Check pending, Regulatory Data Check not compliant. Comments range from 0 to 13. Assigned Batches section lists four batches with IDs CFG_3888 to CFG_3891, Material IDs CFG_0001 to CFG_0004, all available and associated with A001 Test (A001). Each batch includes Protocol ID P000003, Release Decision Trigger IDs, Deviations, Release Checks, and Due Date Jul 30, 2022.

The change history allows you to see changes made for the current PCN release decision item. You are also able to filter a time frame, or search for a specific term.

SAP Change History screen for Technical Release. Release ID: PCN280601_V11_CH32. The screen shows changes made to the PCN Release Decision with a total of 117 listed changes. Columns displayed are Object, Object ID, Object Description, Changed By, Changed On, Attribute, Context, Before Change, and After Change. Entries include changes made by user Test2 Test2 and System on various dates, primarily June 12, 2024, and April 26, 2024. Specific changes include the PCN Release Decision, suitability for release by country (CA, US, CH, DE, AR), and checks for compliance such as Release Check IDs for quality control (QC), change, regulatory, batch record reviews (BRR), and deviations (DEVIAT). There's a date range filter at the top for refining the search.

Perform a Clinical Release Based on Package Control Number - SAP Batch Release Hub for Life Sciences Steps

Watch the simulation Perform the PCN Release - SAP BRH Steps to learn more about the system-related activities.

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