Labroots

Preserving Data Integrity: 21 CFR Part 11 Compliance and Osmolality as a Process Parameter

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 ...
BioTechniques

FDA 21 CFR Part 11 and the importance of regulatory compliance in GMP and GLP labs

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 ...
Nasdaq

Box Sign Achieves Support for FDA 21 CFR Part 11 Compliance to Streamline Regulated E-signature Workflows

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 ...
Forbes

How Federally Regulated Companies Can Comply With FDA CFR 21 Part 11 For Digital Records And Signatures

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 ...