Change Tracking to Comply with FDA 21 CFR Part 11 and Other Regulations

FoxCTS adds enhanced change tracking, security, configuration, and management functions toI/ASeries systems in response of best practices and various regulations.

Regulatory Position

FoxCTS is a response to practices required by FDA regulation 21 CFR Part 11, OSHA 1910, and by other governmental regulations. These regulations require that changes made to a control system be documented and distributed to all affected parties, especially to the process operators and their supervisors, and that access to the system be controlled and monitored. Though FoxCTS provides support for these regulations it is not sufficient by itself to ensure that any given installation is compliant.

FoxCTS

Certification of any given installation as compliant is achieved not only through the application of hardware and software products, like FoxCTS, but also through external review, internal procedures, and a variety of other mechanisms.

Invensys is committed to having a combination of services, policies, procedures and automated tools to facilitate compliance. Please contact your account representative about more information on services provided by Invensys to assist you in meeting theseregulations.