Dublin, Nov. 03, 2022 (GLOBE NEWSWIRE) -- The "21 CFR Part 11 Compliance for SaaS/Cloud Applications" training has been added to ResearchAndMarkets.com's offering. This highly interactive two-day ...
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 ...
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 ...
21 CFR Part 11 compliance requires that closed computer systems must have a collection of technological and procedural controls to protect data within the system. It is like a permission to use ...
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 ...
21 CFR Part 11 compliance is obligatory for all healthcare industries that manufacture or export their products in or to the U.S. market. Part 11 is designed to help FDA-regulated companies benefit ...
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 ...
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 ...
You’re under pressure to innovate quickly and improve patient outcomes. Don’t let paper-based processes, legacy GxP technology, and app sprawl slow you down. Speed up R&D, maintain GxP compliance, and ...