An Investigation into The Implementation of An Electronic Document Management System to an Oral Solid Dose Manufacturing Site, an Evaluation of System Performance Indicators and User Perspectives.
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Abstract
This dissertation critically examines the implementation of an Electronic Document Management System (EDMS) on an Oral Solid Dose (OSD) pharmaceutical manufacturing site. The impact of an EDMS and its effects on document performance metrics, as well as user satisfaction and efficiency are investigated. This study aims to objectively review the introduction of an EDMS in a pharmaceutical manufacturing site in order to support future decision-making in relation to the digital transformation of document management systems to aid overall improved performance, and efficiency on site. This study adopts a combined quantitative and qualitative research design; where data was gathered from an OSD manufacturing site which had an EDMS deployed in case study style research. Quantitative numerical indicators, including document cycle times, process mapping steps, and time at each stage are collected and analytically reviewed. Further primary data was collected using a questionnaire, which was completed by 40 of the employees of the selected OSD manufacturing site, who are users of the recently implemented EDMS system. The questionnaire results provide further quantitative and qualitative data, as well as unique empirical insights into user satisfaction of the EDMS implemented. The findings of this research indicate that the implementation of the EDMS enhanced the document management process by streamlining the steps required, which reduced the process steps required from 11 steps to 8 steps. This resulted in a reduction of the average cycle time by 19.6%. This reduction in cycle time was indicative of a significant improvement in the time required for the review and approval stage which decreased by 46%. The key advantages identified through the user perspectives questionnaire included the increased visibility of workflow and document status, improved carbon footprint and access to affiliate and global documents across the organisational network. There were barriers identified including difficulty learning functionality, user resistance and digital literacy challenges which were prevalent in the immediate stage post-implementation. These challenges considerably reduced over time as user familiarity and confidence using the system increased. There were numerous recommendations provided on ways to improve future deployment and overall user satisfaction with an EDMS, which related to training, supporting documents and system interface enhancement. The research supports the implementation of an EDMS as an approach to enhance the document management process in a pharmaceutical manufacturing site. The adoption of a digitalised system has the potential to streamline document processing, improve document processing cycle time, reduce carbon footprint and allow greater visibility and control over document management tasks. These finding endorse the wider implementation of digitalised DMS and promote the wider digitalization of further systems within the pharmaceutical manufacturing industry