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 ...
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 ...
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 ...
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 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 ...
DeNovix Inc. announces the launch of EasyApps Secure, a 21 CFR Part 11 Compliance Ready software option for CellDrop Automated Cell Counters. The new suite of controls for EasyApps software enables ...
SAN FRANCISCO, Jan. 11, 2012 /PRNewswire/ -- goBalto, developer of new generation web-based clinical research solutions, announced that it successfully completed a FDA 21 CFR Part 11 compliance audit ...
Dublin, May 30, 2023 (GLOBE NEWSWIRE) -- The "6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA" webinar has been added to ResearchAndMarkets.com's offering.
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