Pennsylvania-based Auxilium Pharmaceuticals, founded in 1999, is a fast-growing biotech company that is focused on R&D, manufacturing of active drug substances and marketing its products globally. Based on the Food and Drug Administration’s (FDA) approval of the commercial launch of a new product, Auxilium began a strategic initiative to implement a scalable SAP Enterprise Resource Planning (ERP) solution—adopting a best practice-based, phased approach to support the global launch of their new product.

Auxilium had to gear up to ensure that it could produce their new product and manage the business processes in compliance with the FDA and other agencies.

An integrated, fully validated and compliant ERP system was critical to support business growth as well. The scope of SAP ERP Central Component (ECC) 6.0, which was implemented to support MRP planning in 2009, had to be expanded and validated.

To minimize the overall risk and justify the ROI, Clarkston and Auxilium carried out an ERP and Validation assessment. Clarkston’s Life Sciences assessment methodology was adopted to analyze the impact on business processes, SAP technology and landscape, Standard Operating Procedures and training. This provided key information for defining an overall validation master plan; assessing the impact on key validation deliverables as defined in the master validation plan; and conducting an overall GXP risk assessment. The development of a detailed business case to justify ROI and an implementation roadmap was also important.

At the highest level, the project was a resounding success based on its solid ROI justification. This was backed up by hard numbers and realized quickly—between the first and second year of implementation. There was a 50-percent payoff even before the six-month project was complete. Before the implementation, Auxilium’s warehouse operation was manual, using papers and spreadsheets; now there is no paper involved, and the difference is dramatic. There is complete visibility into the inventory at different stages, and its lifecycle can be tracked electronically.

Some of the Significant Benefits Achieved Included:

• Elimination of manual procedures by automating warehouse management and production logistics processes,
  enabled by SAP ITS-based RF and 2-D bar codes.
• Laying a strong foundation to support future serialization and country requirements.
• Providing capabilities to track detailed multi-level batch genealogy and product flow.
• Fully validated and compliant system meeting regulatory requirements.
• Improved business process integration across the supply chain, manufacturing, warehouse and quality management.