Solution Development for Integrating Regulatory Compliance In the End-to-End Product Development

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

leverx group

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

Customer

Leading European pharmaceutical companies

CHALLENGE

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

SOLUTION

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

Our customers had the following challenges:

Сumbersome and typically manual identification process of impacted materials
The error-prone manual process to add changes to a batch or update batches upon regulatory approval
Challenging creation of new materials and associated master data for each change
Lack of visibility to regulatory dates for planners and manual process to check multiple systems for regulatory dates
Difficulties with tracking changes over time and aligning with regulatory submission versions
Lack of visibility of regulatory dates in logistics processes

Solution’s Description

Leverx Group works with companies and organizations to address the complex challenges of today's business world. Each of our partners is an experienced, innovative, and proven leader in their respective fields.

Automotive

SAP PLM is a solid basis for the automotive industry. This solution helps digitize and automate manufacturing processes and work more efficiently with suppliers and partners.

Aerospace & Defense

The solution allows aerospace and defense companies to reduce the time to market for innovations without compromising safety while simulating innovation scenarios along a complex value chain.

Food & Beverage

SAP PLM provides the food & beverage industry with all the required technologies that help to develop sustainable, traceable, high-quality products within a shorter time.

Consumer Goods

With SAP PLM, this industry can exceed the diverse expectations of consumers and enable sustainably and profitably growth for the business.

Pharma

SAP PLM helps to make pharmaceutical production more effective and with lower risk.

Key Features

Automotive

SAP PLM is a solid basis for the automotive industry. This solution helps digitize and automate manufacturing processes and work more efficiently with suppliers and partners.

Aerospace & Defense

The solution allows aerospace and defense companies to reduce the time to market for innovations without compromising safety while simulating innovation scenarios along a complex value chain.

Food & Beverage

SAP PLM provides the food & beverage industry with all the required technologies that help to develop sustainable, traceable, high-quality products within a shorter time.

Consumer Goods

With SAP PLM, this industry can exceed the diverse expectations of consumers and enable sustainably and profitably growth for the business.

Pharma

SAP PLM helps to make pharmaceutical production more effective and with lower risk.

It is possible with mobile maintenance scenarios and two SAP solutions, SAP Work Manager (SAP WM) и SAP Asset Manager (SAP AM). They provide access to information on asset statuses and allow you to maintain them comprehensively.

SAP WM is a mobile application with wider functionality that offers both on-premise and cloud hosting capabilities.

SAP AM is a more modern cloud-based solution that can be integrated with innovative SAP Cloud Platform IoT.

Both solutions help to improve enterprise asset productivity with constant monitoring, analytics, and timely diagnostics.

Technology Stack

Node.js

SAP CAP Framework

SAP BTP

SAP Event Mesh

HANA Database

Fiori Elements

SAPUI5

JavaScript

Project Scope

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

LeverX Group 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

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

During the use, our clients achieved the following results: