Regulatory Compliance Coverage & Reference between FDA 21 CFR Part 11 and EU Annex 11

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Until recently, clinical trials have been performed in a mostly paper-based processes. Advancements in technology, surge in remote work and digitization of the processes is driving the clinical research industry and consequently, there is increased use of electronic records and electronic signatures to support these processes. Though the regulations around electronic records and signatures, such as FDA 21 CFR part 11 and EU Annex 11, have been published for a long time, their application has amplified manyfold in the recent times. To ensure continued compliance to these regulations, it is imperative for clinical researchers to understand the similarities and differences between these regulations.

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