title: New FDA guidance on electronic records and signatures.
abstract: 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.
authors.affiliation: donawa@srd.it
authors.forename: M
authors.initials: M
authors.lastname: Donawa
mesh_terms: D001319:Authorship; D016494:Computer Security / Q000592:standards*; D032962:Consent Forms / Q000592:standards*; D019451:Information Management / Q000592:standards; D016247:Information Storage and Retrieval / Q000331:legislation & jurisprudence / Q000592:standards*; D008499:Medical Records / Q000592:standards*; D017410:Practice Guidelines as Topic; D012986:Software Validation; D009626:Terminology as Topic; D014481:United States; D014486:United States Food and Drug Administration; D014584:User-Computer Interface; D018875:Vocabulary, Controlled