YSI 2900 Series Analysers are Fully Compliant with the FDA’s 21 CFR part 11 Regulation
YSI’s 2900 Series of Biochemical Analysers incorporate closed computer systems that generate electronic records for United States Food and Drug Administration (FDA) regulated processes.
As such, YSA, like other similar medical and pharmaceutical device companies,must comply with the FDA’s Code of Federal Regulations covering electronic records and signatures. This part of the code, 21 CFR Part 11 (21 CFR 11), is applicable to laboratory results which are then used to determine qualities such as purity, quality, efficacy and safety and strength.
YSI use Good Automated Manufacturing Practices (GAMP® 5) Category 4 configured software in order to assure 21 CFR 11 compliance.
YSI have published a full compliance report to show how their 2900 Series of Biochemical Analysers comply with 21 CFR 11. The report can be downloaded here.
Date added: 2016-08-22 16:39:49