Introducing SAP Batch Release Hub

Objective

After completing this lesson, you will be able to recognize the business value of SAP Batch Release Hub.

Introduction

This lesson will explore the transformation of business operations, improvement of efficiency, and enforcement of compliance by the SAP Batch Release Hub for Life Sciences. Real-world examples illustrate these benefits, making the concepts easy to understand and relate to your business context. The SAP Batch Release Hub for Life Sciences offers substantial business value by centralizing data, improving compliance and quality assurance, enhancing efficiency through automation, providing real-time visibility, and offering scalability. These benefits lead to more streamlined operations, reduced costs, and improved product quality, making the SAP Batch Release Hub for Life Sciences a critical tool for any business involved in batch production.

Note

SAP Batch Release Hub for Life Sciences enables cost reduction and scalability.

Reduced Risk of Quality Noncompliance

By standardizing and simplifying the batch release process, reducing human error risk.

Reduced Compliance and Risk Management Costs

By automating and simplifying the time-consuming and labor-intensive legacy batch release activities.

Reduced Order Fulfillment Lead Time

By enabling faster batch release cycle time, thanks to automation and standardization.

Reduced Inventory Carrying Costs

By reducing the required level of inventory, thanks to shorter lead times for order fulfillment

By using the capabilities of the SAP Batch Release Hub for Life Sciences, companies can ensure that their products meet the highest standards of quality and compliance, all while optimizing their operational efficiency.

Centralized Data Management

One of the most significant advantages of the SAP Batch Release Hub for Life Sciences is its ability to centralize data from various sources into a single platform. Data from multiple systems, such as a Document Management System (DMS), Clinical Trials Management System, and Manufacturing Execution System (MES), used to be manually collected by a pharmaceutical company. This manual process was time-consuming and prone to errors.

The image is a Centralized Data Management diagram illustrating the SAP Batch Release Hub for Life Sciences. At the top is a cockpit gauge labeled Batch release connected to a cloud application. Below, the central hub is connected to various systems: ERP, CTM, and DMS for Supply chain data check (orange), QMS and LIMS for Quality data check (blue), GBT, MES, and ATTP for Manufacturing data check (green), and Artwork and RIMS for Regulatory data check (teal). Each system is represented by an icon and connected to the central hub with dotted lines.

The SAP Batch Release Hub for Life Sciences integrates all these data sources into one platform. This centralization means that employees can no longer switch between different systems to gather information. For instance, if a quality manager must review the batch release status, all relevant data-quality checks, regulatory compliance, and production logs can be accessed from a single dashboard. This integration saves time and reduces the risk of errors, ensuring that the data used for decision-making is accurate and up-to-date.

Example

A pharmaceutical company used to spend an average of 5 hours per batch gathering and verifying data from different systems. After implementing the SAP Batch Release Hub for Life Sciences, this time was reduced to just 1 hour, significantly increasing productivity and reducing error rates.

Improved Compliance and Quality Assurance

Compliance with regulatory standards is crucial in the pharmaceutical and food production industries. The robust tools the SAP Batch Release Hub for Life Sciences provides ensure that the necessary standards are met before releasing products. Integrating regulatory data and quality checks makes complying with various international regulations easier.

Note

SAP Batch Release Hub for Life Sciences provides a comprehensive portfolio for release checks.
The image is a graphical representation titled Improved Compliance and Quality Assurance. It features a list of various checks with blue checkmark icons next to each item. The checks include an Annual product quality review check, Artwork and safety label check, Batch genealogy check, Batch record review check, Certificate check, Change control data check, Clinical trial regulatory check, Clinical trial technical check, Components check, Custom release check, Deviation data check, Quality control data check, Regulatory data check, Serialization data check, Temperature data check, and Transport data check. The note at the bottom states, *Can be configured to consider the related component details; works on the subcomponent level. The image also includes icons of a rising graph, a magnifying glass over a bar chart, and an arrow pointing upwards.

For example, the Batch Release Hub can automatically verify the specific requirements of different countries for each batch. This means a product intended for distribution in the European Union can be checked against EU regulations. At the same time, a batch destined for the U.S. market can be verified against FDA standards. This automated compliance checking reduces the risk of non-compliance and the potential for costly recalls or legal issues.

Example

A food manufacturer experienced frequent delays due to manual compliance checks, often missing critical details. Compliance checks with the SAP Batch Release Hub for Life Sciences are automated, ensuring that every batch meets all relevant standards before release, thus avoiding costly delays and potential fines.

Enhanced Efficiency Through Automation

The SAP Batch Release Hub uses automation for Life Sciences to streamline various processes involved in batch release, such as data entry, document handling, and quality checks. As a result of automation, employees are freed up to focus on more strategic activities.

Screenshot of the SAP My Release Decisions interface. The interface displays a list of release decisions with columns for Batch ID, Material ID, Material Description, Batch Location, Release Decision Trigger ID, Release Decision Trigger Type, Quality Department, Assigned To, and Due Date. A drop-down menu titled Release Checks is open, showing various check IDs, descriptions, and statuses, including ART (Artwork and Safety Label Check - Completed), SER (Serialization Data Check - Compliant), APQR (APQR Check - Pending), CHANGE (Change Control Data Check - Closed), BRR (Batch Record Review - Completed), DEVIAT (Deviation Check - Open), COMPC (Component Check - Pending), QC (Quality Control Data Check - Compliant), TC (Transport Check - Pending), and CERT (Certificate Check - Error). The list includes multiple entries for different batches, materials, and locations, with various statuses and due dates.

In a manufacturing company, quality checks that previously involved manual data entry into spreadsheets, compliance verification, and report preparation are now automated by the SAP Batch Release Hub for Life Sciences, ensuring consistent and accurate quality checks. Automated alerts notify managers of any issues, enabling prompt action.

Example

A cosmetics manufacturer automated the batch release process using the SAP Batch Release Hub for Life Sciences, reducing quality check time by 50%. This allowed quality assurance teams to focus on improving product formulations and other value-added activities.

Real-Time Visibility and Decision-Making​

Real-time visibility into the batch release process is provided by the SAP Batch Release Hub for Life Sciences, allowing up-to-date information on batch status to be accessed by managers, bottlenecks to be identified, and informed decisions to be made quickly.

Screenshot of a dashboard titled Release Decision Overview from SAP. The dashboard is divided into several sections: 1. My Release Decision Items shows 22 items categorized by urgency: 13 urgent, five overdue, and four on time. A pie chart visualizes these categories.; 2. Items Requiring My Intervention lists 5 of 11 items, with details such as item number, description, and overdue days. Examples include items overdue by 23, 20, and 15 days.; 3. Items with Pending or Non-Compliant Checks shows 16 items categorized by urgency: 11 urgent and five overdue. A pie chart visualizes the number of days from the due date. 4. Ready for Release indicates 2 2 items are ready.; 5. Open Deviations shows 0 of 0 items.; 6. Critical Release Decision Items lists 5 of 18 items, with details such as item number, description, and overdue days. An example includes an item overdue by 23 days. The dashboard contains filters for Quality Department, Location, Organizational Area, Material Group, Material Type, Release Type, and Assigned To.

For example, if a batch fails a quality check, the system immediately notifies the relevant personnel, providing detailed information on the issue. This enables faster resolution of problems, minimizing downtime and maintaining production schedules.

Example

After implementing the SAP Batch Release Hub for Life Sciences, a beverage company gained real-time visibility into the batch release process. When a labeling error caused a batch to fail a quality check, the issue was identified and corrected within minutes, preventing a production halt and keeping the delivery schedule on track.

Scalability and Flexibility

The scalability and flexibility of the SAP Batch Release Hub for Life Sciences allow it to be scaled with your business. Whether a small manufacturer or a large enterprise, increasing volumes of data and complexity can be handled without compromising performance.

The image is a flowchart titled Batch Release Processes Transformation at Enterprise Scale. It depicts six stages of the batch release process, each represented by an icon and a label. The stages are: 1. Incoming goods (truck icon); 2. Bulk or semi-finished (icon of a hexagon with a plus sign); 3. Finished goods (icon of a hexagon with a check mark); 4. CMO release (icon of a building with a picture); 5. Market release (icon of a store); 6. Distribution Release (icon of a house with an arrow). Each stage is numbered and connected by a dotted line.

Supported Languages

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

Flexible and Secure Batch Release Management for Diverse Scenarios

Various Release ScenariosTransformed Batch Release Management at Enterprise Scale
  • Commercial products
  • Contract manufacturing organization (CMO) products
  • Individualized therapy products
  • Clinical trial products
  • Standardized solution
  • Extensible by developers
  • Scalable and secure

As new markets enter and the business grows, the Batch Release Hub can adapt to regulatory requirements, additional data sources, and more complex production processes. This ensures that the system continues to deliver value as the business evolves.

Example

A mid-sized pharmaceutical company experienced rapid growth and significant expansion of product lines. The operations were seamlessly scaled with the SAP Batch Release Hub for Life Sciences, and the increased data volume and complexity were handled without any issues, allowing the company to maintain efficiency and compliance.

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