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Message Icon Topic: 21 CFR Part 11 – A Standard for Industry

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tanushree
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Quote tanushree Replybullet Topic: 21 CFR Part 11 – A Standard for Industry
    Posted: 16Oct2007 at 3:28am
21 CFR Part 11 – A Standard for Industry

The Food and Drug Administration’s regulation 21 CFR Part 11 Electronic Records; Electronic Signatures; Final Rule came into effect on August 20 1997. Part 11 applies to industries that are subject to regulation by the FDA. Its purpose is to specify the requirements when electronic systems are used to manage records subject to FDA regulations. Any regulated organisation intending to do business in the United States must comply with all applicable regulations, including Part 11.

Part 11 is split into three parts:

•Subpart A specifies general provisions covering the scope of the regulation, implementation of electronic records systems and definitions.

•Subpart B specifies the electronic records requirements.

•Subpart C specifies the electronic signatures requirements.



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