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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The FDA updated draft guidance for Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers which revamps recommendations from 2017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. ....

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FDA Revises Recommendations Regarding Electronic Systems

Food and Drug Administration FDA issued updated draft guidance, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers. Draft Guidance revamps earlier recommendations from 2017 regarding requirements of 21 CFR Part 11. ....

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iQue® Software Module for 21 CFR Part 11 : Get Quote, RFQ, Price or Buy

Sartorius’ software module for 21 CFR Part 11 compliance for the iQue® product allows stringent compliance procedures to be integrated and logged into everyday function. ....

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