Iconics Suite - FDA 21 CFR 11
This article contains information about Iconics funcionalities in compliance with 21 CFR 11.
21 CFR 11
Using Iconics GENESIS64 solutions allows system integrators to create SCADA applications in compliance with FDA 21 CFR Part 11, which is an American regulation regarding security and auditing especially important in pharmaceutical, food and cosmetics industries (full name: Code of Federal Regulations: Food and Drug Administration Title 21, Chapter I, Part 11 - Electronic Records; Electronic Signatures).
Many FDA regulations, written well before the proliferation of computer systems, require handwritten signatures. In light of the new technologies available, 21 CFR 11 covers the proper handling of recording FDA-regulated information electronically and applying electronic signatures equivalent to handwritten signatures and documents.
Achieving 21 CFR 11 compliance with Iconics
A dedicated document from Iconics attached to this article describes functionalities available to achieve compliance with 21 CFR 11. It includes information about:
- GraphWorX64
- GenEvent Server
- Security Configurator
- Security Server
- Hyper Alarm Logger
- AlarmWorX64 Viewer
- AlarmWorX64 Historical Alarm Report
- AlarmWorX64 Logger
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