PID controllers for the pharmaceutical industry: Gefran presents the Multifunction series with advanced features for the traceability of 21 CFR-compliant data
Gefran has launched the CFR-compliant version of its Multifunction series of multiloop PID controllers, capable of meeting the standards required by the FDA (Food & Drug Administration) under 21 CFR Part 11.
PID controllers for the pharmaceutical industry: Gefran presents the Multifunction series with advanced features for the traceability of 21 CFR-compliant data
Models 2850T and 3850T CFR, ideal for the measurement, recording and control of production processes, already compliant with the AMS2750 standards for the Aerospace industry and CQI9 standards for the Automotive industry, will now include specific features that are necessary in the pharmaceutical industry, in particular for secondary production plants, such as: sterilisation autoclaves, environmental chambers, filtration systems, freeze dryers and laboratory incubators.
“21 CFR Part 11 is a section of the Code of Federal Regulations that establishes the guidelines of the FDA. In particular, this section refers to pharmaceutical products and medical devices. Our family of Multifunction products guarantees compliance with the criteria for electronic records and signatures in terms of accuracy, authenticity, and reliability in a digital format. The new CFR-compliant Multifunction products meet these data processing requirements throughout the production cycle”.