The FDA established the Electronic Records and Electronic Signatures Rule (21 CFR Part 11) in order to outline the necessities for electronic form records and the accepted electronic signatures ...

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 ...

Lack of data integrity is the main reason for most FDA warning letters In 2017, data integrity issues were cited in 65% of all FDA warning letters. The main reason was incomplete data. In the Pharma ...

The regulations for food and drugs in the United States, described in Title 21 of the Code of Federal Regulations (CFR), are critical in ensuring safe and ethical drug administration. Whether you are ...

Agilent Technologies Inc (NYSE: A) today announced the release of a new 21 CFR Part 11 compliance software for the Agilent xCELLigence Real-Time Cell Analysis (RTCA) eSight system. The software ...

Dublin, Jan. 20, 2025 (GLOBE NEWSWIRE) -- The "21 CFR Part 11 Compliance for SaaS/Cloud Application" training has been added to ResearchAndMarkets.com's offering. This highly interactive two-day ...

The FDA rule relating to the use of electronic records and electronic signatures is 21 CFR Part 11. In the early 1990s, the FDA convened a meeting with members of the pharmaceutical sector after ...

SANTA CLARA, Calif., December 01, 2025--(BUSINESS WIRE)--Agilent Technologies Inc (NYSE: A) today announced the release of a new 21 CFR Part 11 compliance software for the Agilent xCELLigence ...