雖然現有文獻對於企業管理軟體的導入已有廣泛探討，但大多聚焦於提升營運效率與財務管理的系統，如企業資源規劃（Enterprise Resource Planning, ERP）系統，但這些研究成果無法直接適用於電子化品質管理系統（Electronic Quality Management System, eQMS）。因為eQMS的核心目標不僅是提升效率，更關鍵的是確保合規性、品質管理及數據完整性，這些特性使其導入過程面臨獨特挑戰。因此，本研究專門探討製藥業導入eQMS的關鍵成功因素，並運用層級分析法（Analytic Hierarchy Process, AHP）進行系統化評估，以填補現有研究的空白並提供更具針對性的導入策略參考。
本研究針對相關ERP文獻回顧以及研究者本身對於製藥業的工作經驗，歸納出10個影嚮製藥業導入eQMS的關鍵因素，主要涵蓋外部環境構面、組織管理構面、資訊技術構面等三個構面。研究結果指出，組織管理構面是最為關鍵，而其中最重要的前三個關鍵成功因素分別為高層管理支持、軟體的合規性及合適的專業團隊。期望藉由本研究的結果，提供給尚未導入eQMS的製藥同業作為參考。

Although existing literature has extensively explored the adoption of business management software, most studies have focused on systems aimed at improving operational efficiency and financial management, such as Enterprise Resource Planning (ERP) systems. However, these research findings cannot be directly applied to Electronic Quality Management Systems (eQMS), as the core objectives of eQMS go beyond efficiency enhancement to ensuring regulatory compliance, quality management, and data integrity. These unique characteristics present distinct challenges in the implementation process. Therefore, this study specifically examines the critical success factors (CSFs) for implementing eQMS in the pharmaceutical industry and employs Analytic Hierarchy Process (AHP) for evaluation, aiming to bridge the research gap and provide more targeted implementation strategies.
Based on a review of relevant ERP literature and the researcher’s own experience in the pharmaceutical industry, this study identifies 10 key factors influencing eQMS adoption in pharmaceutical companies. These factors are categorized into 3 main dimensions: external environment, organization, and technology. The findings indicate that the organization dimension is the most critical, with the top 3 CSFs being top management support, software compliance, and a competent project team. This study hopes to provide pharmaceutical companies that have yet to implement eQMS with valuable insights and a practical reference for successful adoption.

一、中文參考文獻
1.褚志鵬（2009），Analytic Hierarchy Process Theory層級分析法(AHP)理論與實作。

二、英文參考文獻
1.B. Wong and D. Tein, “Critical Success Factors for ERP Projects”. Australian Institute of Project Management Conference Program, AIPM, Sydney, pp. 01 –08, 2003.
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9. Wissam EL HAJJ, Ali SERHAN, “Study on the Factors that Determine the Success of ERP Implementation”, Proceedings of the 13th International Conference on Business Excellence 2019
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11.R. Hendra Kusumawardhana, Imairi Eitiveni, Warda Yaziji, Zahrina Aulia Adriani, “Identifying Critical Success Factors (CSF) in ERP Implementation Using AHP: A Case Study of a Social Insurance Company in Indonesia”, Journal of Cases on Information Technology, Volume 26 , Issue 1, 2024