21 CFR Part 11

Gas Analyzers (O2, CO2, N2) for Monitoring Modified Atmosphere Packaging in Pharmaceutical Products The use of a gas such as oxygen (O2), nitrogen (N2) or carbon dioxide (CO2) or a mixture of gases is commonly used in pharmaceutical packaging such as injection vials, liquid vials, pouches...

21 CFR Part 11 Compliant Instruments for the Pharmaceutical Laboratory The US Food and Drug Administration (FDA) requires that FDA-regulated facilities, such as the pharmaceutical industry, comply with software regulations that are contained in the Code of Federal Regulations (CFR), Title 21, Part 11 in a...