CENTUM CS 3000 R3

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.

Key Points

Actual Results

By supporting control systems with 21 CFR Part 11 compliant capabilities, Yokogawa has gained broad support from customers.

Maintenance of 21 CFR Part 11 Compliant Package

The 21 CFR Part 11 Compliant package not only fully conforms to the 21 CFR Part 11 regulations, but also improves maintenance convenience and management efficiency.

Compatible with Legacy Control System

A legacy control system (CENTUM-XL) can be gradually upgraded to a 21 CFR Part 11 compliant system with the full use of existing assets.

Step 1: Upgrade Operator Console to 21 CFR Part 11 Compliant

Add new HIS

Step 2: Upgrade Instrumentation Engineering and Recipe Engineering Stations to 21 CFR Part 11 Compliant

Add new builder packages and replace the CPU (FCS) to the latest version.

Implement 21 CFR Part 11 compliant packages.

At this stage the legacy system becomes a complete CS 3000 R3 system.

Catalog of FDA : CFR Part 11 Compliant Package


	CENTUM CS3000 R3