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21 CFR Part 11 is a regulation stipulated by Food and Drug Administration of United States. In 21 CFR Part 11, FDA approves the electronic records and electronic signatures compliant to the regulation are equivalent to the conventional paper documents. In a control system, the functionality for complying 21 CFR Part 11 consists of "Access Control" and "Audit Trail“.
(FDA: Food and Drug Administration)
Access Control (User Authentication)
Protecting the system and data from illegal accesses
Complete user authentication by applying specific restrictions to each user.
Audit Trail
Operation records (When, Who, What, Where, Why, How) are automatically recorded.
The 21 CFR Part 11 compliant activities carried out in CENTUM CS 1000 R3 are categorized in the groups of operator, instrumentation engineer and recipe engineer.
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