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The DAQSTATION DX9100P/DX200P paperless recorders for Pharmaceutical were designed to comply with the requirements of 21 CFR Part 11.

21 CFR Part 11 is a regulation stipulated by the Food and Drug Administration of the United States. With 21 CFR Part 11, the FDA defines the criteria for determining which electronic records and electronic signatures may be considered the equivalent of 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 access.
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 compliance activities carried out with the CENTUM CS 3000 R3 are categorized according to the following groups: operators, instrumentation engineers, and recipe engineers.



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