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”.
Click here and read the press release.