As the latest version of the vendor’s Windows-based, OEM-friendly HMI software, InteractX version 2.0 includes a streamlined HMI toolset for compliance with the FDA’s 21 CFR Part 11 and Good Manufacturing Process (cGMP) standards that require operator tracking and e-signatures.
InteractX’s Operator Tracking and E-Signature tools track events transparently, as part of daily operator activities, or can be used for operator authentication and supervisor approval E-Sig compliance needs. Simple checkboxes allow application developers to set approval requirements for specific events, while allowing operators to indicate desired changes in machine operation, reasons and authentication of his or her identity through predefined popup dialogs. Multiple user levels are available to establish approval requirements, and the system logs historical data to record events, requests, identities and approvals, creating a complete audit trail on a machine or group of machines.
No special programming or scripting is required. Machine OEMs will find it easy to deploy this solution to users in the field, says the vendor, thanks to auto detection of user admin security for Windows networks and seamless IT integration of MS access, SQL and OBDC database logging.
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