21 CFR Part 11 – A Standard for Industry
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Printed Date: 28Jun2024 at 4:44pm
Topic: 21 CFR Part 11 – A Standard for Industry
Posted By: tanushree
Subject: 21 CFR Part 11 – A Standard for Industry
Date 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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