LIFE SCIENCES
Driving digital manufacturing through paperless production
To modernise its manufacturing operations, a pharmaceutical production site launched a digital transformation initiative aimed at replacing paper-based batch records with a Manufacturing Execution System (MES). The objective was to improve process efficiency, enhance traceability, and strengthen compliance with GxP requirements while ensuring seamless integration with existing business systems.
The challenge
The project required the digitalisation of the entire manufacturing lifecycle, from process instructions to batch review. This involved replacing manual and paper-based processes with a compliant digital solution while maintaining operational continuity.
Key challenges included:
- Digitalising production instructions and batch documentation
- Integrating the MES with the site’s existing SAP environment
- Ensuring traceability of manufacturing data throughout the production process
- Managing user adoption and training across production, quality, and supervisory teams
Maintaining compliance with GxP requirements throughout the transformation
The solution
ALTEN supported the deployment of the MES solution through a structured digitalisation approach focused on:
- Production order execution: Managing and executing manufacturing orders digitally to ensure consistent and controlled shop floor operations
- Recipe and process management: Modelling and configuring manufacturing recipes within the MES to standardise production processes and enforce operational procedures
- Electronic workflows and operator guidance: Replacing paper-based activities with digital work instructions, approvals, and guided execution workflows
- Equipment and resource management: Coordinating machines, operators, and materials to improve production efficiency and resource utilisation
- Electronic Batch Records (eBR): Automating the generation of batch records and manufacturing documentation while ensuring data integrity and compliance
- ERP integration: Implementing bidirectional integration with SAP for manufacturing orders, material consumption, and Bill of Materials (BOM) management
- Real-time process monitoring and control: Providing visibility into production activities, process deviations, alarms, and key manufacturing parameters to support faster decision-making and operational control
Results & benefits
The MES implementation delivered significant operational and quality improvements:
- Elimination of paper-based batch records and reduction of manual entry errors
- End-to-end traceability of production data in real time
- 50% reduction in batch review time through automated review-by-exception (CABR)
- Improved efficiency through automated workflows and digital documentation
- Strengthened compliance with GxP requirements and audit readiness
- Improved production productivity through the optimisation of shop floor workflows
- Enhanced visibility of manufacturing activities through real-time monitoring
- Better utilisation of equipment, materials, and personnel
- Faster and more reliable production order execution
Reduced manual interventions and operational inefficiencies
Key project takeaways
This project demonstrates how MES solutions can transform pharmaceutical manufacturing by connecting production operations with digital systems. Through the implementation of MES capabilities including production order execution, electronic workflows, resource management, real-time process monitoring, SAP integration, and electronic batch records, ALTEN helped create a more productive, traceable, and compliant manufacturing environment while supporting the site’s long-term digital transformation journey.
