SAP Batch Release Hub for Life Sciences

Name: leverX Company
Brand: LeverX
Rating: 4.9 (114 reviews)

Transform the life sciences industry processes with SAP Batch Release Hub

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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.

Why Choose LeverX as Your SAP Implementation Provider?

Proven track record

For over 20 years, we have helped businesses worldwide succeed with SAP. We’ve already completed 950+ projects for over 800 clients, including top names on the Fortune 500 list.

Industry experts

The LeverX team comprises professionals with hands-on knowledge in 30+ industries, including manufacturing, logistics, and oil  and gas.

SAP partnership

We implement SAP projects end-to-end  and collaborate with SAP on the development and enhancement of its existing solutions.

Quality and security track record

LeverX operates in compliance with international standards such as ISO 9001, ISO 27001, ISO 22301, and ISO 55001, ensuring reliability and quality in every project.

Investment in innovation

We actively integrate advanced technologies, such as Data Science, IoT, AI, Big Data, Blockchain, and others, to help clients efficiently address their business challenges.

Flexibility

Our team is available 24/7, which enables us to quickly deploy projects, maintain process transparency, and adapt each development phase to meet your specific requirements.

Implementation Roadmap

We follow the SAP Activate methodology, which breaks down the implementation of SAP Batch Release Hub for Life Sciences into six essential stages:

Current Processes Evaluation: Assess existing business processes and identify the organization's needs.
Defining Technical Requirements: Create a detailed specification of the functional and technical needs of the new system.

Discover

Setting Goals and Objectives: Establish and agree on the goals to be achieved throughout the project.
Assembling the Project Team: Appoint team members and define their roles and responsibilities.
Project Plan Development: Create a comprehensive plan that outlines project phases, timelines, resources, and key performance indicators.
Budget Determination: Estimate and approve the budget.
Specifications Preparation: Develop the technical and functional specifications for the development team.

Prepare

Ensuring Business Requirements are Met: Check that SAP BRH aligns with business requirements and project objectives.
Data Validation: Verify the accuracy and compliance of the data.

Explore

Data Migration: Transfer data from existing systems to the new one.
System Configuration: Set up the solution according to requirements and specifications.
Customization: Develop additional features and modules, if the standard solution does not meet all needs.
Integrations: Configure SAP BRH to work with other IT systems and applications.

Realize

Testing: Perform functional, integration, regression, and load testing to ensure that all works correctly.
User Training: Organize sessions to help users become familiar with the new system.

Deploy

System Readiness Check: Verify that the system is ready for operational use.
Launch: Officially transition to active use of SAP BRH.
Ongoing Support: Continuously monitor solution performance to identify and resolve any issues.

Run

FAQ

Can SAP BRH handle multistep batch release processes?

Yes, SAP BRH supports complex release workflows and enables multistep approvals and adherence to strict release protocols.

How does SAP BRH support quality management?

SAP BRH integrates with quality management systems, allowing companies to monitor quality and ensure batch consistency.

How does SAP BRH integrate with other SAP solutions?

SAP BRH integrates with SAP ERP, SAP QMS, and other SAP life sciences solutions, creating a cohesive approach to batch management.

Can SAP BRH provide batch traceability?

Yes, SAP BRH provides complete traceability for each batch, helping companies manage recalls and meet regulatory traceability requirements.

1

An expert will reach out to you to discuss your specific migration needs and requirements.
2

We'll sign an NDA to ensure any sensitive information is kept secure and confidential.
3

We'll work with you to prepare a customized proposal based on the project's scope, timeline, and budget.