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A Review On Scope And Application Of 21 Cfr Part 11
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| Author:
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V.S.THIRUVENGADARAJAN, I.PONNILAVARASAN, GOWTHAM.A, LOGANATHAN A
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| Abstract:
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The 21 CFR, Part 11 is the code of federal regulations that establishes under USFDA regulations on electronic records and electronic signatures used for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, and medical devices. Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP) and its 50 titles that represent broad areas subject to Federal regulation. Each title is divided into chapters, which usually bear the name of the issuing agency. The Validation of computerized system, Audit Trail, Legacy System, Copies of Records, Record Retention. In this review article, an attempt has been made to compile the reported 21 CFR Part 11 scopes and applications to drug makers, medical device manufacturers, biotech companies, biologics developers, CROs, and other FDA-regulated industries.
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| Keyword:
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21CFR Part 11, USFDA, Audit Trail, Legacy System, Record Retention.
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.03.241
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| Download:
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Request For Article
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