On 20 February 2003, the US Food and Drug Administration (FDA) published a new draft guidance relating to 21 CFR Part 11. The new guidance mainly affects the compliance requirements of systems with a ...
21 CFR Part 11 (Part 11) establishes U.S. Food and Drug Administration (FDA) regulations on electronic records and signatures. In the pharmaceutical world, some of the first questions we get asked is: ...
The benefits of using computers and electronic records are proven in most fields of modern-day work, none more so than in laboratories. The opportunities for automation have improved productivity; the ...
The FDA rule relating to the use of electronic records and electronic signatures is 21 CFR Part 11. In the early 1990s, the FDA convened a meeting with members of the pharmaceutical sector after ...
The regulations for food and drugs in the United States, described in Title 21 of the Code of Federal Regulations (CFR), are critical in ensuring safe and ethical drug administration. Whether you are ...
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