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zenon

and FDA 21 CFR Part 11 compliance

zenon creates compliant HMI/SCADA projects in a framework of regulation, embracing the FDA 21 CFR Part 11 regulations forms the beginning of how zenon manages validated projects efficiently with built in functionalities, zenon offers much more.



FDA 21 CFR Part 11

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FDA 21 CFR Part 11

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All functionalities are integral to zenon and designed solely by COPA-DATA, this offers severe advantages to simplifying the validation process as all functionalities works seamlessly together as one product, from a standalone application to a fully integrated client-server relationship.

 

Being able to implement this level of functionality through configuration enhances this environment further, as a GAMP software category 4 product validation efforts are significantly reduced.

Audit trail and version control: Design modifications at any stage of a projects life-cycle are logged & reported in detail, zenon's project version control ensures effective project management for GMP environments.

Audit Trail and Alarm management: secure traceability of all process and operator actions.

User Administration: full local user administration and zenon's compatibility with Windows and Active Directory, brings a secure environment to any unique situation.

GAMP software category 4: Provides full FDA 21 CFR Part 11 compliance through project configuration where no programming is needed, thus removing significant validation workload and management from a project.

Integrated solution: one environment for HMI/SCADA with a full suite of functionality, and perfect connectivity to other systems through native drivers and communication protocols.

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Find additional information about zenon and FDA 21 CFR Part 11 compliance in the zenon Compass.