More than half of the U.S. adult population today uses dietary supplements, including vitamins and minerals. Supplements in the U.S are currently regulated by the Federal Drug Administration as “foods,” not “drugs.” This is an important distinction; drugs must be shown to be effective as well as safe, while foods are only required to demonstrate safety.
FDA guidelines cover not only the manufacture of supplements but their data management as well, including the storage and protection of electronic records and the application of electronic signatures. With more than 50,000 dietary supplements on the market, this can get quite complicated.
4Life Research, a leading Utah-based dietary supplement manufacturer, uses Agilent OpenLAB software to help ensure the quality and safety of its products. “From the moment we generate data, Agilent’s OpenLAB ECM [Enterprise Content Manager] and ELN [Electronic Lab Notebook] provide a secure repository,” says 4Life’s David Vollmer. “If we make any changes, those changes are noted, validated and signed off, so we have traceability throughout the whole process.”
“Many dietary supplement manufacturers aren’t aware that Agilent offers a solution to help them comply with FDA regulations,” says Agilent’s Archie Hoggan. “The 4Life sale has helped us address that situation. Ever since the installation of Agilent’s OpenLAB ECM and ELN at 4Life, the company has served as an advocate and reference for more potential business.”
This information is for research purposes only. It is not intended for any use in diagnostic procedures.
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