Topic: 21 CFR Part 11 – A Standard for Industry

Message

   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.

Author	Message
tanushree Senior Member Joined: 04Apr2007 Online Status: Offline Posts: 2160	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. Post Resume: Click here to Upload your Resume & Apply for Jobs

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