This industry traditionally is burdened by a lot of trivial paper work and MES can leverage this burden and simultaneously improve compliance. Recently MES have also been introduced along with operational excellence programs in pursuit of improvements using MES as data source for optimisation analysis. However the deployment of MES into an existing organisation often raises a number of challenges, both of technical and of organisational nature.
In the past quite a number of MES projects have faced difficulties, partly because the platforms for the solutions have been immature and forced organisations to add functionality by in-house development and partly because the organisational change effort has been underestimated. Introduction of MES is by nature across functional change effort which requires careful preparation and full support by all management levels to complete successfully.
NNE Pharmaplan has implemented more than 10 full-blown MES solutions using 5 different platforms and implemented more than 25 partial MES solutions supporting both API and fill finish facilities in the pharmaceutical industry worldwide. Based on this experience this paper will provide a number of good advices for companies who want to go the MES way. It describes all necessary steps form the initial business analysis to the daily support during operation illustrated by practical examples.
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About the author:
Leif Poulsen holds a Ph.D. degree in engineering from the Technical University of Denmark and is currently a Senior Specialist within Automation & IT at NNE Pharmaplan.
Leif Poulsen was awarded ISA's 'Excellence in documentation award' for this article. The award recognises and encourages the presentation of significant information in instrumentation, systems, and automation.