A recent report indicated that in 2016, around 79% of 483 warning letters from the FDA to the pharmaceutical industry highlighted weaknesses in data integrity. 1 The FDA outlines its expectations for ...
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 ...
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 ...
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 ...
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 ...
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 ...
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