JD Supra

FDA Finalizes Guidance on Use of Part 11 Electronic Systems, Records and Signatures in Clinical Investigations

On October 1, 2024, the US Food and Drug Administration (FDA) finalized its guidance on the use of electronic records in clinical investigations of drugs, devices, biologics, foods, tobacco products ...

WEBINAR: FDA's 21 CFR Part 11 Add-on Inspections: Address Software That is Supporting the Company's Quality System and CGMP Documentation

Market opportunities arise in providing solutions for cGMP software verification and validation, addressing increased FDA scrutiny. Demand exists for expertise in FDA guidelines, risk management ...
JD Supra

FDA Clinical Investigations: New Guidance on Electronic Systems

On October 2, 2024, the U.S. Food and Drug Administration (FDA) released guidance in a question and answer format regarding the use of electronic systems, electronic records, and electronic signatures ...
Forbes

How Federally Regulated Companies Can Comply With FDA CFR 21 Part 11 For Digital Records And Signatures

Lila Kee is the General Manager for GlobalSign’s North and South American operations, as well as the company's Chief Product Officer. Sweeping changes brought on by digitalization have emphasized the ...
The National Law Review

FDA Revamps Guidance Concerning Use of Electronic Systems, Records, and Signatures in Clinical Investigations

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
The National Law Review

FDA Revises Recommendations Regarding Electronic Systems, Records, and Signatures in Clinical Investigations

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
Nasdaq

Box Sign Achieves Support for FDA 21 CFR Part 11 Compliance to Streamline Regulated E-signature Workflows

REDWOOD CITY, Calif.--(BUSINESS WIRE)-- Box, Inc. (NYSE:BOX), the leading Content Cloud, today announced that its native e-signature product, Box Sign, has achieved support for compliance with FDA 21 ...