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  2. Title 21 CFR Part 11 - Wikipedia

    en.wikipedia.org/wiki/Title_21_CFR_Part_11

    Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)).

  3. Common Rule - Wikipedia

    en.wikipedia.org/wiki/Common_rule

    The Common Rule is a 1991 rule of ethics (revised in 2018) [2] regarding biomedical and behavioral research involving human subjects in the United States.The regulations governing Institutional Review Boards for oversight of human research followed the 1975 revision of the Declaration of Helsinki, and are encapsulated in the 1991 revision to the U.S. Department of Health and Human Services ...

  4. Code of Federal Regulations - Wikipedia

    en.wikipedia.org/wiki/Code_of_Federal_Regulations

    In the law of the United States, the Code of Federal Regulations (CFR) is the codification of the general and permanent regulations promulgated by the executive departments and agencies of the federal government of the United States. The CFR is divided into 50 titles that represent broad areas subject to federal regulation.

  5. Title 21 of the Code of Federal Regulations - Wikipedia

    en.wikipedia.org/wiki/Title_21_of_the_Code_of...

    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). [1] It is divided into three chapters: Chapter I — Food and Drug Administration

  6. Laboratory information management system - Wikipedia

    en.wikipedia.org/wiki/Laboratory_information...

    A LIMS covers standards such as 21 CFR Part 11 from the Food and Drug Administration (United States), ISO/IEC 17025, ISO 15189, ISO 20387, Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), FDA Food Safety Modernization Act (FSMA), HACCP, and ISBER Best Practices.

  7. Computerized system validation - Wikipedia

    en.wikipedia.org/wiki/Computerized_system_validation

    The validation process begins with validation planning, system requirements definition, testing and verification activities, and validation reporting. The system lifecycle then enters the operational phase and continues until system retirement and retention of system data based on regulatory rules.

  8. Declaration of Helsinki - Wikipedia

    en.wikipedia.org/wiki/Declaration_of_Helsinki

    This means that there was an 11-year gap between comprehensive revisions (from 1964 to 1975) and a 25-year gap (from 1975 to 2000), respectively. Consequently, the DoH, essentially in its 1975 version, had a quarter-century to establish itself within the medical research community, and this has significantly contributed to its current status.

  9. Investigational New Drug - Wikipedia

    en.wikipedia.org/wiki/Investigational_new_drug

    The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.

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