SAP Electronic Batch Record System (MES)
A very large pharmaceutical manufacturer was experiencing a number of FDA complaints around non-compliant shop floor activities. Additionally, the manufacturer was investigating standalone MES packages in order to provide better cost savings. SAP was the strategic platform for the company, and it was a core requirement that the shop floor activities be fully integrated with the SAP-planning functions.
After consulting with the client, Endeavor determined that a holistic strategy and implementation service — to provide an integrated MES solution — was needed. This would include a full Electronic Batch Record, covering recipe management, production control, quality control, and batch disposition.
First, it was necessary to select a vendor and run the proof of concept (POC) process. Based on a successful POC, SAP technology was selected as the foundation layer for the solution. Endeavor resources provided architectural, functional, quality, validation, and business resources that developed the SAP solution utilizing PP-PI technology.
The project delivered in 18 months, including:
• The development of new business processes
• Technical configuration
• ABAP programming
• Integration with Batch Management and Data Historian technology
• Full GMP validation and user training
Included in the program was the development of multiple product recipes, all of which could be fully managed by a native SAP solution. The solution was fully integrated with SAP planning, materials management, quality, and plant maintenance modules.
The ECG solution is fully functional in multiple work centers within one manufacturing plant. Plans are also currently in place to provide a full “end to end” Electronic Batch Record, which will include all work centers and multiple production plants.
The system has met or exceeded all business metrics for enforced compliance, operational efficiency, and quality release. Our solution is based on standard SAP technology, with minimal customization, and is now fully supported by the client's internal SAP staff via one FTE.
Due to the use of standard SAP technology the solution is fully integrated with all SAP functions, and naturally fits as new SAP functions are provided in other business areas.