ISPE GAMP SIG MES Planning to Move the Industry Forward
With a recent increase in interest and participation, the ISPE GAMP® Special Interest Group (SIG) focusing on Manufacturing Execution Systems (MES) has mapped out an ambitious number of subject areas to use as the basis for future publications, presentations, and best practice guidance documents. With the co-leadership of Christian Wöelbeling, Executive Industry Advisor at Körber Pharma Software GmbH and Mark Wager, Quality Consultant at Eli Lilly and with ISPE sponsorship from ISPE International Board of Directors Chair, Mike Rutherford, Executive Director, Computer Systems Quality & Data Integrity at Syneos Health and the team of over thirty industry professionals is sharpening their focus on the implementation and use of MES for the purposes of verification and validation of Master Batch Records, Audit Trails, Data Integrity, and integration with process control systems among others.