The contract laboratory environment creates some unique compliance problems because most laboratories work with many clients, often in many different locations, The recently issued U.S. FDA Electronic Records and Electronic Signatures rules (21 CFR Part 11) are among the agency's most challenging standards, and this article describes how one contract laboratory delivers data to its customers that is compliant with the new standards. [References: 6]
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机译：合同实验室环境会带来一些独特的合规性问题，因为大多数实验室通常与许多客户在很多地方工作，因此，最近发布的美国FDA电子记录和电子签名规则（21 CFR Part 11）是该机构最具挑战性的标准之一，本文介绍了一个合同实验室如何向其客户提供符合新标准的数据。 [参考：6]
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