21 CFR Part 11 is a section of the US Code of Federal Regulations (CFR) established by the Food and Drug Administration (FDA). This section regulates electronic records and electronic signatures in the pharmaceutical, biotechnology and medical industries. The aim is to ensure that electronic data and signatures are just as reliable and trustworthy as paper-based documentation. This regulation is particularly relevant in the following industries:

• Pharmaceutical production
• biotechnology
• Food and beverage industry
• Medical device industry

21CRF Part 11 Polarimeter

Our VariPol Polarimeter especially designed for pharmaceutical applications, 21 CFR Part 11 ready and uses 21 CFR Part 11 compliant software.