The spring of 1997 was a significant time for theFood and Drug Administration (FDA). An overhaul of the Agency’s Good Manufacturing Processes (GMP) brought changes that had not been seen for a quarter ...
Dublin, Dec. 04, 2024 (GLOBE NEWSWIRE) -- The "21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries" webinar has been added to ResearchAndMarkets.com's ...
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 ...
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 ...
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 ...
IDBS has announced that its complete E-WorkBook Suite has been independently validated by the Sociedad de Validacion de Sistemas (SVS) against the FDA’s 21 CFR Part 11 and Good Laboratory Practice ...
This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach ...
The spring of 1997 was a significant time for theFood and Drug Administration (FDA). An overhaul of the Agency’s Good Manufacturing Processes (GMP) brought changes that had not been seen for a quarter ...
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