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FDA Updates Electronic Systems in Clinical Investigations Guidance

The FDA updated draft guidance for Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers which revamps recommendations from 2017 on the requirements of 21 CFR Part 11 and use of technologies in clinical investigations.

FDA Revamps Guidance Concerning Use of Electronic Systems, Records, and Signatures in Clinical Investigations | Nelson Mullins Riley & Scarborough LLP

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