電子實驗記錄使用效益研究—以藥物產物為例

The benefit of Electronic Laboratory Notebook: A case study in the pharmaceutical industry

阮怡靜(Yi-Jing Ruan)

指導教授 ： 廖秀莉

中原大學/商學院/資訊管理研究所/碩士(2019年)

https://doi.org/10.6840/cycu201900475

摘要

摘要
隨著規範製藥產業的法規日益趨嚴，實驗資料記錄與保存方式更加重要，對於實驗數據的保存、管理及應用都是相當重要，導入電子實驗記錄系統(ELN)將會是未來趨勢。本研究選擇以本公司導入的電子實驗記錄系統為切入點，以藥廠研發人員為對象，藉由深度訪談方式，了解導入電子實驗紀錄後會對研發單位帶來的效益為何。
本研究以個案訪談方式進行。得知以下發現：
1. 對於導入新系統滿意度：新進同仁較資深同仁高。
2. 系統模組功能不足影響使用者意願：多數使用者認為系統應結合外部資源及內部資源， 提供使用者在記錄實驗過程中的參考資料；系統應結合實驗室的儀器設備及軟體，達到實驗數據能更快速準確地被記錄。
3. 管理效率增加：ELN依照專案分類不同專案中，使計畫主持人可察看實驗進度，在專案成員有更動時，將實驗內容得以重新調整。
4. 提升實驗記錄文件品質：標準化的實驗報告模板，使資料記錄、儲存變得更容易，並可以將實驗內容以圖片檔、影片檔上傳至ELN。

關鍵字：電子實驗記錄、績效評估、實驗室信息、電子化文件管理

關鍵字

電子實驗記錄 ； 績效評估 ； 實驗室信息 ； 電子化文件管理

並列摘要

Abstract
As the regulations regulating the pharmaceutical industry become stricter, the method of recording and storing experimental data is more important. It is very important for the preservation, management and application of experimental data. The introduction of electronic laboratory notebook (ELN) system will be the future trend.
This study chooses to use the electronic laboratory notebook system introduced by the company as the entry point. For the researcher of pharmaceutical companies, I hope that through in-depth interviews, we will understand the benefits that will be brought to the R&D units after the introduction of electronic laboratory notebooks.
Through case interview, this paper arrived at the following findings:
1. For the introduction of the system satisfaction, the senior colleagues are higher than the new colleagues.
2. The system module function is insufficient. Most users think that the system should integrate the external and internal resources to provide users with reference materials during the recording experiment. ELN should be combined with laboratory equipment and software to achieve experimental data that can be recorded more quickly and accurately.
3. Privilege rating, the advanced privileged members of the project can view the experimental content of the next level member. Experiment content cannot be viewed in the same course. If you need an audit, you must submit an application for review. Once approved, you can view the experiment data of others.
4. Improve the quality of experimental record files, standardize experimental report templates to make data recording and storage easier, and allow images and movies to be uploaded to ELN.

Key words: Electronic Laboratory Notebook, benefit evaluation, electronic information, electronic document management

並列關鍵字

Electronic Laboratory Notebook ； benefit evaluation ； electronic information ； electronic document management

參考文獻

參考文獻

英文部分：

1. Brown, Mark G. and Svenson, Rayonld A., (1998). Measuring R & D Productivity. Research Technology Management, 30-35

2. Cooper, R. G. and Kleinschmidt E. J., (1995). Benchmarking the firm’s Critical Success Factors in New Product Development. Journal of Product Innovation Management, 12(3), 374-391.

3. Franks, Patricia C., (2013). Records and information management. American Library Association. EBook, Chapter 6: Electronic Records and Electronic Records Management Systems. 145-146