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.

leverx

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

customer

Customer

Leading European pharmaceutical companies

CHALLENGE

Challenge

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

SOLUTION

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.

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

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.

PROJECT SCOPE

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

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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
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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

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
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