In today’s life sciences landscape, companies are under mounting pressure to deliver innovative therapies while navigating an increasingly complex regulatory environment. Global supply chains, fragmented product portfolios, and jurisdiction-specific compliance requirements demand a more intelligent, integrated approach to enterprise systems.

PwC helps life sciences organizations address evolving regulatory and operational complexities through the application of SAP S/4HANA’s jurisdictional controls and segmentation capabilities—enhanced by PwC’s tailored Industry Edge solution. Developed based on experience with leading life science companies, this approach helps support compliance alignment, supply chain visibility, and operational resilience.

The Challenge: Complex Compliance Meets Operational Reality

Global life science companies operate across diverse markets, each with their own set of stringent regulations and approval processes. Jurisdictional controls should confirm that only approved products reach the right patients, while inventory segmentation should track, classify, and differentiate materials across the overall value chain. This process often requires manual reconciliation across ERP, planning tools, and document management systems and therefore introduces delays, errors, and regulatory exposure.

To address this challenge, companies have traditionally introduced multiple SKUs based on regulatory approvals to uniquely identify products and manage inventory across the supply chain. However, this approach can lead to significant product proliferation, manual intervention, and document reconciliation. It also increases volume and complexity for master data, such as material and purchasing masters, making data maintenance and governance increasingly complex and resource intensive. Despite these efforts, fragmented solutions often fall short of meeting compliance needs and frequently require additional custom developments, which further increase system complexity and degrade user experience.

Without embedding segmentation into the digital core, organizations face compliance risks, material inefficiencies, and impaired patient service levels.

Our Solution: Tailored Segmentation for Life Sciences

PwC has developed a tailored segmentation solution in SAP S/4HANA, designed specifically for the life sciences industry. This solution can track and enforce regulatory compliance based on key product characteristics such as manufacturing sites, testing sites, bill of materials (BOM) version, and process, method and equipment (PME). This segmentation logic applies across the life science multi-level product hierarchy, e.g. including packaged finished goods, drug product, and drug substance for biopharma. Every valid combination of attributes defines a unique segment of the product, aligned with the market authorization approvals.

This framework embeds these attributes directly into SAP S/4HANA and integrates effectively with SAP Integrated Business Planning (IBP), quality, and logistics systems. It also enables holistic jurisdictional control that is native to the ERP environment, decreasing manual reconciliation, and reducing compliance risk.

• Holistic Segmentation: Segmentation attributes flow across demand planning, procurement, manufacturing, quality, logistics, and financial processes—creating a consistent compliance structure across the value chain.
• Jurisdictional Compliance: Configurable, country-specific controls help organizations align production, shipment, and sales activities with market authorizations.
• Operational Efficiency: Streamlined data governance helps reduce redundancy and supports improved visibility for planning and decision-making.
• AI-Enabled Intelligence: Machine learning can enhance data quality validation, detects anomalies across batch records, and supports predictive analytics within regulatory constraints. 

Our solution aligns with the SAP product roadmap while addressing industry-specific gaps such as split valuation and batch-level determination. It is tailored for life science companies to manage product variations throughout their product lifecycle, from early development and clinical trials to commercialization and launch.

Real-World Impact: Global Implementation at Scale

PwC worked with a global biopharmaceutical organization to help deploy jurisdictional controls and segmentation within their SAP S/4HANA environment. This implementation delivered:

• Regulatory Compliance: Automated alignment with market authorizations across 50+ countries.
• Improved Traceability: Segment-level tracking from raw materials to finished goods, confirming holistic compliance and audit readiness.
• Uplifted Patient Need Fulfilment: Demand, supply, inventory planning systematically aligned with sales order management segmentation rules.
• Data Governance and Quality: A centralized segmentation repository, aligned with Bill of Materials (BOMs), Purchasing Information Records (PIRs), and batch records, driving a single source of truth.
• Business Agility: Accelerated readiness for new market launches.