FDA Regulation Title 21 CFR Part 11 REFRACTOMETERS AND POLARIMETERS FROM BELLINGHAM + STANLEY

How to comply with FDA Regulation Title 21 CFR Part 11 What is FDA Regulation Title 21 CFR Part 11? FDA Regulation Title 21 CFR Part 11 (also known as 21 CFR 11), Electronic Records/Electronic Signatures, is the part of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures. Specifically, 21 CFR 11 defines the requirements for submitting documentation in electronic form and the criteria for approved electronic signatures. Who needs to comply? All FDA-regulated industries, which includes...

Key benefits for 21 CFR 11 RFM900-T Series refractometers, ADP450 polarimeter & ADP600 Series polarimeters offer the following key benefits for 21 CFR 11. • Compliance without an intermediate PC – less data security risk and lower system cost • Server synchronised clock to prevent data tampering • Multi-reading PHR Method for batch measurement as per GLP/PHR • Print to Secure PDF with custom header (customer logo can be input) • Electronic signatures including multi-verification (Submitter > Reviewer >> Approver) • XML output strings with encryption & MD5 check for easy connection to LIMS/Server...

1) The tissue in plants that brings water upward from the roots; 2) a leading global water technology company. Bellingham + Stanley is part of Xylem Analytics and a leading provider of refractometers and polarimeters. Xylem Analytics’ global brands have been leaders in the laboratory instrumentation market for decades, and are relied upon every day across more than 150 countries. Working in true partnership with our clients, we listen, learn and adapt to individual needs, offering deep application expertise built upon our long history of innovation in instruments and services. Our solutions for...