Implementation and Replacement of an Engineering Drawing Solution in a Pharmaceutical Manufacturing from an Information Technology Standpoint

Abstract

The pharmaceutical industry is a highly and strictly regulated environment. The quality, support and management of its processes and data generated are important aspects this type of industry needs to sustain. The department of Information Technology (IT) is accountable for most of these processes driven by regulatory agencies and Good Manufacturing Practices. One of the many businesses Information Technology leverages is the Engineering Information Management (EIM). The influence of technology in manufacturing has evolved to a point where it is possible to have interconnected and integrated systems across global companies. A Commercial off-the-shelf software product was selected in an initiative, from the global Manufacturing Pharmaceutical Company X, to replace their multiple solutions to a single one; standardizing global procedures, increasing efficiency and improving end user experience in the process. Lean Six Sigma methodology was used to define requirements and to develop a global strategy for implementation of the solution. Key Terms - DMAIC, Engineering Information Management, IT, Pharmaceutical Industry.