YSI’s 2900 Series Analysers are fully compliant with the United States Food and Drug Administration regulation 21 CFR Part 11 covering electronic records and electronic signatures.
United States Food and Drug Administration (FDA) regulated industries such as the food and beverage, pharmaceutical, cosmetics and medical device industries must comply with that part of the Code of Federal Regulations covering electronic records and signatures.
This regulation, 21 CFR Part 11(21 CFR 11), covers computer systems that store data in order to report to the FDA or to make quality decisions. This includes laboratory results then used to determine factors such as purity, quality, efficacy, safety and strength.
YSI, a leading world water technology company, have published a compliance report to show how their YSI 2900 Series of Biochemical analysers, which incorporate closed computer systems that generate electronic records for FDA regulated processes, are fully compliant with 21 CFR 11. The full report can be downloaded from this page.
