臺灣博碩士論文加值系統

製藥業在過去幾十年間皆採用批量生產方式製造藥品。這種業界情況主要是以往製藥業的監管政策非常嚴謹以及行業保守性質的結果。然而，現今數位經濟快速發展過程中，致使許多傳統管理方法大量導入數位化。因此，製藥業因應數位化潮流將傳統批量生產轉化為連續生產數位化也就變得十分重要。因此，本研究通過案例研究，提出了一個解決方案架構，提高製藥業的於轉換連續生產過程中，將重點放在整體數位化解決方案，並嘗試透過此方法應用於從倉庫到轉廠以及維護活動的生產資源管理。研究中並與文獻其他報告進行結果比較討論，以說明本研究可協助製藥制
業數位化轉換過程。

Medical device manufacturing enterprises have practiced batch manufacturing to produce their products in decades. In batch manufacturing, products are produced in a determined amount of quantity through a multi course of process. This structure is the upbringing from conventional practice in industry and of historical regulatory policy. In the course of digital economy, the extensive introduction of digitalization to traditional management approach, is of particular importance. Moreover, a strategy towards digitalization is equally important as it progressively impacting environmental sustainability through efficiency of resource and information. All these urges medical device manufacturing companies to maintain competitive advantage as a lean and sustainable-minded enterprise. The lack of reports and research in successful transformation for these cases creates impossibility to run the mission. Therefore, this paper proposes a framework through a case study within the scope of asset management to enhance manufacturing process in medical device industry by engaging on the empirical strategy for successive digital implementation. This approach is applied in investigating the manufacturing asset management from warehouse to the shopfloor along with maintenance activities, this result is discussed with reference to other reports in the literature. This will therefore pave the roadmap for efficient adoption of digitalization across the pharmaceutical manufacturing industry.

English Abstract....i
摘要....iii
Acknowledgment....iv
Table of Contents....v
List of Figures....vii
List of Tables....viii
Chapter 1 Introduction....1
1.1.Research Background....1
1.2.Statement of the Problem....3
1.3.Purpose of the Study....3
1.4.Research Limitation....3
1.5.Research Outline....4
Chapter 2 Literature Review....5
2.1.Digitalization Technologies....5
2.2.Asset Management....7
2.3.Weibull Distribution....10
2.4.Conclusion 11
Chapter 3 Research Methodology 12
3.1.Introduction....12
3.2.Exploratory Research....12
3.3.Descriptive Research....13
Chapter 4 Research Result....20
4.1.System Architecture....20
4.2.Gap Analysis & Migration Plan....30
4.3.Impact on Production Throughput....31
4.4.Impact on Social, Environmental and Economic Values....34
Chapter 5 Conclusion....35
5.1.Conclusion....35
5.2.Limitation and Future Work....36
References....37
Appendix....41
Appendix 1. Collected Data from Shop Floor MES system....41
Appendix 2. Weibull Distribution Calculation....41
Appendix 3. Weibull CDF Data Chart (30 days)....42
Extended Abstract....44

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