At LITX , we help pharmaceutical and chemical manufacturers leverage SAP S/4HANA industry best practices to ensure compliance, quality, efficiency, and traceability across every stage of production.
Our solutions empower organizations to streamline R&D, production, supply chain, and regulatory processes while maintaining full control over quality and cost.
Industry Challenges and Solutions
Regulatory Compliance: Navigating complex regulatory landscapes requires robust compliance management and traceability.
Supply Chain Complexity: Managing intricate supply chains involving raw materials, intermediates, and finished products demands seamless integration and visibility.
Quality Control: Ensuring consistent product quality and safety across all processes and stages is crucial for maintaining consumer trust and meeting industry standards.
Production Planning and Process Management
Formula and Recipe Management
Define and control product formulations, recipes, and batch sizes to ensure consistent quality and compliance with GMP and FDA standards.
Batch and Process Manufacturing
Manage both continuous and batch-based processes, supporting precise control over chemical reactions, temperature, and material composition.
Co-Products and By-Products Handling
Record and manage co-products, by-products, and rework streams within production orders for accurate cost and yield calculations.
Process Order Execution
Execute detailed process instructions and monitor production in real time with full integration between SAP S/4HANA and shop floor systems (MES, DCS, LIMS).
Capacity Planning and Scheduling
Optimize utilization of reactors, mixers, and packaging lines using advanced PP/DS tools for efficient batch sequencing and minimal setup times.
Quality, Compliance, and Regulatory Management
- Integrated Quality Management (QM)
Enforce in-process, release, and stability testing with automatic results recording and deviation management. - Regulatory Compliance (GMP, FDA, REACH)
Maintain complete electronic records and audit trails in line with 21 CFR Part 11, GxP, and other industry regulations. - Electronic Batch Records (EBR)
Generate and store batch manufacturing records electronically to ensure full traceability and compliance documentation. - Stability Study Management
Track product stability studies over defined time intervals and conditions to comply with regulatory and shelf-life requirements. - Document Control & Digital Signatures
Manage controlled documents (SOPs, test methods, specifications) with approval workflows and digital signatures.
Inventory and Supply Chain Management
- Batch Management & Traceability
Achieve full forward and backward traceability from raw materials to finished pharmaceuticals or chemicals, ensuring total quality transparency. - Hazardous Material Management
Handle, classify, and store dangerous goods safely with automated compliance checks during procurement, production, and shipping. - Characteristic-Based Inventory
Manage stock based on key attributes such as purity, potency, viscosity, color, and concentration. - Cold Chain & Environmental Monitoring
Integrate IoT sensors to monitor temperature, humidity, and pressure for temperature-sensitive pharma materials. - Vendor and Supplier Collaboration
Strengthen supplier quality agreements and automate incoming material inspections through SAP Ariba or Supplier Portal integrations.
Sales and Customer Relationship Management
- Batch-Specific Sales and Delivery
Ensure customers receive compliant batches with full CoA (Certificate of Analysis) and expiration data. - Customer Contract and Pricing Management
Automate contract-based pricing, rebates, and regulatory-specific taxes (GST, excise, etc.) for pharmaceutical and chemical clients. - Product Configuration and Labeling
Generate customized product labels with regulatory data, safety symbols, and multilingual instructions. - Serialization and Track & Trace
Manage serialization and unique product identifiers across global distribution to prevent counterfeiting and ensure regulatory compliance.
Asset, Maintenance, and Safety Management
- Predictive Maintenance
Leverage IoT and predictive analytics to minimize equipment downtime and optimize maintenance schedules for reactors, centrifuges, and packaging lines. - Environmental Health & Safety (EH&S)
Monitor hazardous emissions, manage safety incidents, and ensure environmental compliance with integrated EH&S features. - Calibration and Validation Management
Maintain validation records for critical equipment and automate calibration reminders to meet regulatory requirements.
Financial and Operational Analytics
- Costing and Profitability Analysis
Track costs across formulas, processes, and plants with real-time margin analysis to manage raw material volatility. - Embedded Analytics and KPIs
Access live dashboards for production yield, batch performance, and compliance metrics powered by SAP Fiori. - Integrated Finance and Controlling
Gain real-time visibility into budgets, project costs, and cash flows — ensuring faster financial close and improved profitability control. - Regulatory and Compliance Reporting
Generate audit-ready reports for agencies such as FDA, EMA, and local regulatory bodies with accuracy and consistency.
Transform Your Pharma and Chemical Operations with LITX
With LITX’s SAP Best Practice Framework, your organization gains:
- End-to-end visibility across R&D, production, and supply chain
- Real-time quality and compliance monitoring
- Enhanced asset reliability and operational safety
- Faster innovation cycles with reduced total cost of ownership
Empower your digital transformation journey with LITX — delivering SAP S/4HANA solutions built for the Pharma and Chemical industry.
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Quality, Compliance, and Regulatory Management
Integrated Quality Management (QM)
Enforce in-process, release, and stability testing with automatic results recording and deviation management.
Regulatory Compliance (GMP, FDA, REACH)
Maintain complete electronic records and audit trails in line with 21 CFR Part 11, GxP, and other industry regulations.
Electronic Batch Records (EBR)
Generate and store batch manufacturing records electronically to ensure full traceability and compliance documentation.
Stability Study Management
Track product stability studies over defined time intervals and conditions to comply with regulatory and shelf-life requirements.
Document Control & Digital Signatures
Manage controlled documents (SOPs, test methods, specifications) with approval workflows and digital signatures.
Inventory and Supply Chain Management
Batch Management & Traceability
Achieve full forward and backward traceability from raw materials to finished pharmaceuticals or chemicals, ensuring total quality transparency.
Hazardous Material Management
Handle, classify, and store dangerous goods safely with automated compliance checks during procurement, production, and shipping.
Characteristic-Based Inventory
Manage stock based on key attributes such as purity, potency, viscosity, color, and concentration.
Cold Chain & Environmental Monitoring
Integrate IoT sensors to monitor temperature, humidity, and pressure for temperature-sensitive pharma materials.
Vendor and Supplier Collaboration
Strengthen supplier quality agreements and automate incoming material inspections through SAP Ariba or Supplier Portal integrations.
Sales and Customer Relationship Management
- Batch-Specific Sales and Delivery
Ensure customers receive compliant batches with full CoA (Certificate of Analysis) and expiration data. - Customer Contract and Pricing Management
Automate contract-based pricing, rebates, and regulatory-specific taxes (GST, excise, etc.) for pharmaceutical and chemical clients. - Product Configuration and Labeling
Generate customized product labels with regulatory data, safety symbols, and multilingual instructions. - Serialization and Track & Trace
Manage serialization and unique product identifiers across global distribution to prevent counterfeiting and ensure regulatory compliance.
Asset, Maintenance, and Safety Management
Predictive Maintenance
Leverage IoT and predictive analytics to minimize equipment downtime and optimize maintenance schedules for reactors, centrifuges, and packaging lines.
Environmental Health & Safety (EH&S)
Monitor hazardous emissions, manage safety incidents, and ensure environmental compliance with integrated EH&S features.
Calibration and Validation Management
Maintain validation records for critical equipment and automate calibration reminders to meet regulatory requirements.
Financial and Operational Analytics
Costing and Profitability Analysis
Track costs across formulas, processes, and plants with real-time margin analysis to manage raw material volatility.
Embedded Analytics and KPIs
Access live dashboards for production yield, batch performance, and compliance metrics powered by SAP Fiori.
Integrated Finance and Controlling
Gain real-time visibility into budgets, project costs, and cash flows — ensuring faster financial close and improved profitability control.
Regulatory and Compliance Reporting
Generate audit-ready reports for agencies such as FDA, EMA, and local regulatory bodies with accuracy and consistency.
Transform Your Pharma and Chemical Operations with LITX
With LITX’s SAP Best Practice Framework, your organization gains:
- End-to-end visibility across R&D, production, and supply chain
- Real-time quality and compliance monitoring
- Enhanced asset reliability and operational safety
- Faster innovation cycles with reduced total cost of ownership
Empower your digital transformation journey with LITX — delivering SAP S/4HANA solutions built for the Pharma and Chemical industry.
Best Practices Implementation
- Template-Based Approach: Utilize industry-specific templates to accelerate deployment, ensuring alignment with best practices.
- Process Harmonization: Streamline and standardize business processes across functions to enhance efficiency and reduce complexities.
- Data Migration and Integration: Seamlessly migrate legacy data and integrate diverse systems to create a unified and transparent data landscape.
Value-Added Services
- Real-Time Analytics: Leverage real-time analytics capabilities of SAP S/4HANA to gain actionable insights, aiding in informed decision-making and strategic planning.
- Advanced Planning and Optimization: Implement advanced planning tools to optimize inventory, production, and distribution, reducing costs and improving responsiveness.
- Predictive Maintenance: Utilize predictive analytics to anticipate equipment failures and optimize maintenance schedules, ensuring uninterrupted operations.
Continuous Support and Enhancement
- 24/7 Support: Benefit from round-the-clock support to address any issues promptly, minimizing downtime and ensuring business continuity.
- Regular Updates and Training: Stay updated with the latest SAP innovations and best practices through regular updates and comprehensive training programs for your team.