MES and Electronic Batch Recording (EBR) have become critical business applications for most large and mid-size pharmaceutical manufacturers. The initial implementations of these technologies focused on translating the paper batch record to something filled out on a computer (Paper on Glass), which eliminated a significant amount of manual data entry and made manufacturing data visible for further analysis. Although this resulted in significant quality and efficiency gains, there was still much room for innovation. The next level of implementation focused on direct integration of MES to DCS and SCADA systems, eliminating manual entry in MES and pulling EBR relevant process data automatically into the system. Although valuable in achieving the goal of eliminating data entry issues, managing a large number of direct equipment interfaces could be complex to validate and manage. Most recently, a number of Werum and OSI customers have focused on interfacing the MES only to the historian, which acts as the gateway for MES to obtain the critical equipment information required for batch release. Leveraging the existing interfaces between the historian and the equipment, and adding a single interface from MES to the historian simplifies the overall project architecture and improves the cost of ownership. With this approach, Werum’s MES is able to combine GMP compliant raw data with other EBR results.This presentation will review how Werum’s PAS-X MES system uses OSI specific adaptors to flexibly pull key data into the EBR for specific processes at the correct times. It will also review some of the past challenges of this approach, and how they have been addressed with new capabilities in OSIsoft’s product suite.
Mr. Puich has been with Werum since January of 2008, primarily focused on North American Sales and Program Management for the company. He is directly involved with implementations of Werum’s PAS-X MES product at customer sites, as well as supporting organizations as they maximize the benefits of using such a system. Mr. Puich came to Werum with a over 10 years of consulting experience as a partner focused on the pharmaceutical and biotech sectors with Tefen USA, a leading Operations Management Consulting firm. Mr. Puich focused on organizational transformations and operations excellence programs in supply chain, manufacturing, quality assurance, and quality control. He holds a Bachelors Degree in Physics from UC Berkeley and Masters Degree in Industrial Engineering and Engineering Management from Stanford University.