Integrating Regulatory Compliance Into Pharmaceutical Batch-Release Processes

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

Client and Challenge

LeverX worked with leading European pharmaceutical companies that needed a more efficient and reliable way to incorporate regulatory requirements into batch-release processes.

Their existing processes relied heavily on manual work and data spread across multiple systems. Regulatory information was not always readily available to the teams that needed it, making change management more complex and increasing the risk of errors and delays.

Key challenges included:

• Manual identification of materials affected by regulatory changes
• Error-prone updates to batches following regulatory approval
• Creation of new materials and related master data for individual changes
• Limited visibility into regulatory dates for planning teams
• Manual checks across multiple systems to verify regulatory information
• Difficulty tracking changes against regulatory submission versions

Solution

LeverX developed SAP BRH, a centralized solution for managing regulatory information and supporting batch-release decisions based on relevant data. The solution brings regulatory data and workflow steps into a single process, helping teams reduce manual work and compliance risk while improving visibility across batch-release activities.

The solution provides:

• Workflow automation for batch-release processes
• A single platform for managing the batch-release cycle
• Flexible configuration for different batch-release scenarios
• Regulatory compliance management
• Structured data visualization
• Electronic signatures and audit logs
• Role-based applications
• Integration with SAP and third-party solutions

LeverX was responsible for:

• Business requirements analysis
• Functional consulting
• Development of BRH and its API
• BRH implementation and configuration
• Integration with SAP S/4HANA and external systems

Technology Stack

The solution was built on SAP Business Technology Platform (SAP BTP) using technologies for application development, data management, messaging, and user interface development.

• Application platform: SAP BTP
  Provides the cloud foundation for developing, running, integrating, and extending the BRH solution.

• Application framework: SAP Cloud Application Programming Model (SAP CAP)
  Supports the development of application services and business logic for BRH.

• Runtime: Node.js
  Provides the server-side JavaScript runtime used for BRH application services.

• Database: SAP HANA Cloud
  Stores and processes application data required by BRH.

• Messaging: SAP Event Mesh
  Supports asynchronous, event-driven communication between applications and services.

• User interface: SAP Fiori elements and SAPUI5
  Provide the framework and UI technologies used to build role-based applications and user experiences.

• Programming language: JavaScript
  Used in the development of BRH application components.

Results

In 2022, SAP BRH was implemented in both customers' environments and went live. The solution helped streamline batch-release processes, improve access to regulatory information, and reduce the manual effort involved in compliance-related activities.

Following implementation, the customers achieved:

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

These improvements reflect the impact of connecting regulatory data with batch-release and operational processes, giving teams a more consistent basis for compliant release decisions.