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听众
性别保密
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发表于 2016-6-17 22:07:46
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1. Please clarify the following terms as they relate to CGMP records:
a. What is “data integrity”?
For the purposes of this guidance, data integrity refers to the completeness,
consistency, and accuracy of data. Complete, consistent, and accurate data should
be attributable, legible, contemporaneously recorded, original or a true copy, and
accurate (ALCOA).
FDA的文件。
http://www.fda.gov/downloads/dru ... ances/ucm495891.pdf
所以,Integrity是包括了完整性,一致性和准确性这三重意思在一起的。
至于怎么在中文里同时表现这三个意思,呃,需要找更专业的翻译人员了。
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