文章基本信息

标题：Security issues for systems used for collecting, storing and interpreting human biological data
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作者：David Harrison
期刊名称：Journal of Commercial Biotechnology
印刷版ISSN：1478-565X
出版年度：2002
卷号：8
期号：4
DOI：10.5912/jcb447
语种：English
出版社：thinkBiotech LLC
摘要：Over recent years there has been a substantial increase in the number of computerised systems used within the healthcare industry. The system's operation and the data produced are vital in ensuring the safety and efficacy of pharmaceutical products. At the same time the healthcare industry has been battling to keep ahead of the increasing regulatory demands of computerised system validation, one integrated component of which is system security. This paper looks at the regulatory requirements for system security and considers the impact of 21 CFR Part 11 on system security methods and practices.
关键词：computer systems validation;physical security;logical security;biometrics;non-biometrics;21 CFR Part 11