SAP Electronic Batch Record System (MES)

A very large pharma manufacturer had experienced a number of FDA observations regarding shop floor activities that were not fully compliant. In addition the manufacturer had investigated standalone MES packages to provide improved cost savings. SAP was the strategic platform for the company and a core requirement would be that the shop floor activities would be fully integrated with the SAP planning functions.

The client needed a holistic strategy and implementation services to provide an integrated MES solution to provide full Electronic Batch Record including recipe management, production control, quality control and batch disposition. The initial phase was a vendor selection process and proof of concept (POC). Based on a successful POC, SAP technology was selected as the foundation layer for the solution.

Endeavor resources provided architectural, function, quality, validation and business resources that developed the SAP solution utilizing PP-PI technology. The new capabilities were delivered in 18 months and included development of new business processes, technical configuration, ABAP programming, integration with both Batch Management and Data Historian technology, testing, full GMP validation and user training. Include in the program was development of multiple product recipes that could be fully managed by a native SAP solution. The solution is fully integrated with SAP planning, materials management, quality and plant maintenance modules.

The solution is fully functional in multiple work centers within one manufacturing plant and plans are in place to provide a full ‘end to end’ Electronic Batch Record that 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. The solution is based on standard SAP technology with minimum customization and is now fully supported with the clients internal SAP support 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.