本文選題：藥品生產(chǎn)企業(yè) + 數(shù)據(jù)完整性　； 參考：《中國(guó)藥房》2017年13期

【摘要】：目的:為藥品生產(chǎn)企業(yè)數(shù)據(jù)完整性管理體系的完善提供參考。方法:根據(jù)美國(guó)FDA與國(guó)家食品藥品監(jiān)督管理總局的相關(guān)報(bào)道,分析數(shù)據(jù)完整性問(wèn)題來(lái)源,歸納數(shù)據(jù)完整性問(wèn)題的原因并提出解決措施。結(jié)果與結(jié)論:企業(yè)出現(xiàn)數(shù)據(jù)完整性問(wèn)題的原因可歸結(jié)于員工、硬件/軟件系統(tǒng)和質(zhì)量管理體系三方面,各方面與現(xiàn)行標(biāo)準(zhǔn)存在較大差距。建議企業(yè)采取差距分析的方法評(píng)估現(xiàn)有體系,組建數(shù)據(jù)完整性管理項(xiàng)目團(tuán)隊(duì)并加強(qiáng)人員培訓(xùn),升級(jí)硬件/軟件系統(tǒng)保證其安全性、穩(wěn)定性和有效性,通過(guò)建立良好文件規(guī)范、數(shù)據(jù)完整性專項(xiàng)監(jiān)管體系來(lái)優(yōu)化質(zhì)量管理體系;此外,企業(yè)應(yīng)建立質(zhì)量文化、實(shí)時(shí)關(guān)注行業(yè)與法規(guī)動(dòng)態(tài),以有效保證數(shù)據(jù)的完整性。
[Abstract]:Objective: to provide reference for the perfection of data integrity management system in pharmaceutical manufacturing enterprises. Methods: according to the relevant reports of FDA and the State Administration of Food and Drug Administration, the sources of data integrity problems were analyzed, the causes of data integrity problems were summarized and solutions were put forward. Results & conclusion: the reasons of data integrity problems in enterprises can be attributed to three aspects: employee, hardware / software system and quality management system. It is suggested that enterprises should adopt a gap analysis approach to evaluate existing systems, form data integrity management project teams and strengthen personnel training, upgrade hardware / software systems to ensure their security, stability and effectiveness, and establish good documentation specifications. In addition, the enterprise should establish quality culture, pay attention to the industry and regulation in real time, so as to ensure the integrity of data effectively.
【作者單位】： 中國(guó)藥科大學(xué)國(guó)際醫(yī)藥商學(xué)院;
【分類號(hào)】：R95
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本文編號(hào)：2071286