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The United States Food and Drug Administration (FDA) is in the process of developing and issuing a series of guidance documents on electronic records and signatures requirements. This article discusses two recently published FDA guidance documents: validation requirements for electronic records and signatures and a glossary of terms. It also highlights the need for industry to provide comments on these documents to FDA.
美国食品药品监督管理局（FDA）正在制定并发布一系列关于电子记录和签名要求的指导文件。本文讨论了FDA最近发布的两份指导文件：电子记录和签名的验证要求以及术语表。文章还强调了行业向FDA提供对这些文件的意见的必要性。
