SAP Batch Release Hub for Life Sciences

Transform the life sciences industry processes with SAP Batch Release Hub

leverx group

The Life Sciences industry is highly regulated and must comply with multiple policies. The most critical one is quality control, and the batch release process is an integral part of maintaining that quality. Before the active pharmaceutical ingredients (APIs) are released for manufacturing, they have quite a way to go before the final drug product can be released into the market. Therefore, manufacturers need a digital tool that enables them to comply with all the regulatory requirements while reducing time to market release.

SAP Batch Release Hub for Life Sciences is an advanced digital hub designed to automatically collect and evaluate all the quality and regulatory data needed for batch release. It has a user-friendly, intuitive office interface that empowers quality control teams to make faster, more accurate batch release decisions.

The hub ensures fewer risks for the entire team, helps lower inventory costs, and reaches the market faster and more consistent order fulfillment with the capacity to optimize batch sizes. This improves company productivity, is logistically sustainable, and financially transforms business.

Low-quality product recalls

Manufacturers are accountable to customers for damage caused by defective products. The potential harm can lead to irrevocable consequences concerning human health and enormous costs and reputational damage.

Lack of process visibility

The batch release process requires full visibility for detecting and responding to threats before distribution. Tracking for better release quality is crucial for manufacturers who aim to maintain security while reducing compliance risks.

Unintentional human errors

Incorrect assembly, counting and measurement errors, erroneous labeling, and subjectivity in decision-making may result in personal injury or property damage. Minimizing human errors is one of the top priorities for manufacturers.

Legacy siloed systems

Siloed systems cause serious issues such as duplicate data, inconsistent communication, access risks, and other process-related challenges. This can lead to longer lead times and a limited perspective of the big picture.

End-to-end view of the batch release process

No blank spaces left within the digital hub! Be methodical and strategic and get detailed information on batch details, including genealogy information, deviations list, country approvals, and inspection lots.

Increase compliance by reducing manual effort

Determine compliance with all established, approved written procedures before a batch is released. The automated batch release process refines the metrics used to track risks and improves the speed at which manufacturers can respond to risks.

Transparency of release check results

Cut bottom-line costs by adding full visibility to the batch release process. Have on hand an overview of critical data points across business functions, thus easily overcoming challenges affecting the efficiencies in quality control processes.

Cockpit

Batch release

Cloud Service

Batch Release Hub
(BRH)

Serialization Data

ATTP

Supply Chain Data

CTM
LIMS
DMS (CO)

Regulation Data

RIMS

Quality Data

Serialization Data

ATTP

Supply Chain Data

CTM
LIMS
DMS (CO)

Manufacturing Data

Regulation Data

RIMS

Quality Data

Manufacturing Data

20% reduction in quality costs – savings of $20 million

The massive efficiency gains resulting from QM reduced time spent checking batches on exceptions can significantly reduce operating costs, thereby reducing the cost of quality. Even a 20% reduction in the cost of quality for a company could result in an average savings of $20 million.

Development of the implementation strategy based on the customer's business requirements and solution capabilities.

Discover

Project plan and goals finalization. Together with the customer, we determine a project structure, management, tracking, and reporting mechanisms. At this stage, roles and responsibilities in the project team are defined.

Prepare

Verification phase. We make sure that the solution and project scope meet the customer's business requirements.

Explore

Customization and integration of SAP components into the customer's IT infrastructure. Our experts configure and further develop the system if required.

Realize

Data transfer from legacy systems into the SAP production system, tests, and roles/authorizations validation for all users.

Deploy

Run the solution with the provision of go-live support, fixes, and monitoring to perfectly adapt the new software to your business processes..

Run