Change Management Solutions

The FDA's requirements for electronic records as defined in regulation 21 CFR Part 11 has a tremendous impact on life science manufacturing operations. Designed with this in mind, GE Fanuc Life Science offers the industry's leading solution for version control and change management of control software. Among our broad selection of applications is Proficy Change Management to assist FDA regulated companies in achieving compliance in their automation systems.

Components:
Provides Electronic Record Keeping
Electronic Signature
Complete Audit Trails
Record Security
Designed for 21 CFR Part 11 Technology

White Papers

White Paper

Proficy Change Mgmt &
21 CFR Part 11

The following is a copy of the 21 CFR Part 11 specification with responses on how Manager can be used in a networked environment to assist in achieving 21 CFR Part 11 validation. Achieving Part 11 compliance requires a combination of properly implemented products with sufficient training and procedures. Read More.

Technical White Paper

Proficy Change Management - Technical White Paper

Manager is a product that provides a solution for managing data assets in an industrial environment. Data Assets in a plant include PLC Programs, CNC Programs, HMI/SCADA application files, CNC data, CAD drawings, Robot programs and more. Read More.

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GE Fanuc industrial solutions include Proficy automation software, embedded solutions, motion control systems, overall equipment effectiveness (OEE) software, and CNC software, parts and retrofits.