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21 CFR Part 11What is Title 21 CFR Part 11?
The Code of Federal Regulations Title 21 CFR Part 11 (referred to as 21 CFR Part 11) regulates the use of electronic systems in clinical trials. Any pharmaceutical company seeking to submit their clinical trial results to the US Food and Drug Administration (FDA) must first comply with 21 CFR Part 11 as part of their trial and pharmaceutical commercialization process.

Gear LeverThe Changing Business Processes Situation
Some manufacturers are now commercializing their own products and are starting to function as wholesale distributors as well. The economic compulsion behind this strategy shift is bearing fruit, however it is instigating changes to business process more quickly and more profoundly than has previously been the case.