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淺談制藥企業(yè)數(shù)據(jù)完整性建設(shè)之時(shí)間管理

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摘 要 本文根據(jù)制藥企業(yè)的數(shù)據(jù)完整性建設(shè)趨勢,分析制藥國際化道路上各法規(guī)和指南中對時(shí)間戳的管理要求,結(jié)合制藥企業(yè)的特點(diǎn),給出時(shí)間同步的實(shí)現(xiàn)方法和在實(shí)踐中應(yīng)關(guān)注的事項(xiàng),用以提高制藥企業(yè)時(shí)間管理水平,促進(jìn)數(shù)據(jù)完整性。

關(guān)鍵詞 數(shù)據(jù)完整性 時(shí)間管理 時(shí)間同步 時(shí)間戳

中圖分類號:R951 文獻(xiàn)標(biāo)志碼:C 文章編號:1006-1533(2023)07-0060-05

引用本文 王靜. 淺談制藥企業(yè)數(shù)據(jù)完整性建設(shè)之時(shí)間管理[J]. 上海醫(yī)藥, 2023, 44(7): 60-64.

Time management of data integrity construction in pharmaceutical enterprises

WANG Jing

(Shanghai SPH Zhongxi Pharmaceutical Co., Ltd., Shanghai 201806, China)

ABSTRACT The management requirements of timestamps in various regulations and guidelines on the road of pharmaceutical internationalization were analyzed according to the trend of data integrity construction of pharmaceutical enterprises, and the implementation method of time synchronization and the matters needing attention in practice were presented by combination of the characteristics of pharmaceutical companies, so as to improve the time management level of pharmaceutical enterprises and promote data integrity.

KEY WORDS data integrity; time management; time synchronization; timestamp

近年來,國家集采、藥品上市許可持有人制度、新版《藥品管理法》等政策與法律法規(guī)不斷推進(jìn)了我國制藥企業(yè)創(chuàng)新發(fā)展,也不斷提高了質(zhì)量管理水平。(剩余5132字)

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