How to use a refractometer or polarimeter to comply with FDA 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.

Bellingham + Stanley manufacture refractometers and polarimeters that can help you satisfy the requirements of FDA regulation 21 CFR Part 11 throughout your pharmaceutical workflow.