Measuring samples as small as 65 uL and returning results in just 35 seconds, our new Vi-CELL MetaFLEX™ bioanalyte analyzer evaluates pH, pO2, pCO2, glucose, lactate, electrolytes and more. With less maintenance, more reliability and a surprisingly small footprint, it’s a sophisticated research solution that profiles test samples quickly, easily and accurately—keeping your test cell cultures in balance, viable and growing.
R&D, QC and Manufacturing Applications
21 CFR Part 11
The Electronic Records and Electronic Signatures Rule (21 CFR Part 11) was established by the Food and Drug Administration (FDA) to define the requirements for submitting documentation in electronic form and the criteria for approved electronic signatures. Since analytical instrument systems such as the Vi-CELL MetaFLEX generate electronic records, these systems must facilitate compliance with the Electronic Records Rule. The Vi-CELL MetaFLEX features the following key system components to facilitate 21 CFR 11 compliance: