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Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered ...
Computerized Systems Used In Clinical Trials (CSUCT) is a guidance document established by the U.S. Food and Drug Administration in 1999 and revised in 2007. [1] [2] It is legally binding in the United States.
Recently both the American FDA and the UK Medicines and Healthcare products Regulatory Agency have added sections to the regulations specifically for the use of computer systems. In the UK, computer validation is covered in Annex 11 of the EU GMP regulations (EMEA 2011). The FDA introduced 21 CFR Part 11 for rules on the use of electronic ...
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
Electronic data capture. An electronic data capture (EDC) system is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials. [1] EDC replaces the traditional paper-based data collection methodology to streamline data collection and expedite the time to market for drugs and ...
Health information technology (HIT) is "the application of information processing involving both computer hardware and software that deals with the storage, retrieval, sharing, and use of health care information, health data, and knowledge for communication and decision making". [8] Technology is a broad concept that deals with a species' usage ...
The U.S. Food and Drug Administration (FDA) has also offered guidance and driven regulation on medical software, particularly embedded in and used as medical devices. [2] [12] [13] [14] There was an expansion of medical software innovation with the adoption of electronic health records and availability of electronic clinical data. In the United ...
An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.