SOLUTION DEVELOPMENT FOR INTEGRATING REGULATORY COMPLIANCE IN THE END-TO-END PRODUCT DEVELOPMENT

LeverX assisted with facilitating the efficient and compliant delivery of medicinal products.

Customer

Leading European pharmaceutical companies

Challenge

Our customers faced regulatory challenges that depended on siloed data and data access, change management, manual processes, and human factors.

Solution

LeverX developed the SAP Batch Release Hub (BRH) solution to deal with these and other issues. It provides data-based batch release decisions with lean, efficient, and streamlined processes that reduce effort and risk in complying with life sciences regulations.

Background

Our customers faced the following challenges:

• Сumbersome manual identification process of impacted materials
• The error-prone manual process of adding changes to a batch or updating batches upon regulatory approval
• Creation of new materials and associated master data for each change
• Inaccessible regulatory dates for planners and manual process to check multiple systems for regulatory dates
• Difficulty tracking changes and aligning with regulatory submission versions
• Lack of visibility of regulatory dates in logistics processes

Products and Services

• SAP Business Technology Platform
• SAP Implementation

Project Scope

BRH scoping and implementation considered the customer’s specific business requirements.

LeverX contribution:

• Analyzing business requirements
• Functional consulting
• Developing BHR and its API
• BHR implementation
• Solution configuration
• BRH integration with SAP S/4HANA and external systems

Solution Benefits

Here are the key benefits of the SAP Batch Release Hub:

• Workflow automation
• A single platform for managing the full cycle of batch release
• Flexible configuration for various-batch release scenarios
• Regulation compliance management
• Structured visualization of data
• Electronic signature and audit logs
• Role-based applications
• Integration with SAP and third-party solutions

Technology Stack

• NODE.JS
• SAP CAP FRAMEWORK
• SAP BTP
• SAP EVENT MESH
• HANA DATABASE
• FIORI ELEMENTS
• SAPUI5
• JAVASCRIPT

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Results

In 2022, SAP BRH was successfully implemented in both customers’ systems and put into operation. This solution helped companies optimize and accelerate batch release processes.

During the use, our clients achieved the following results:

• 10%–20% lower risk of quality non-compliance
• 5%–50% lower compliance and risk management costs
• 5%–50% shorter order fulfillment lead time
• 1%–25% lower inventory carrying costs