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 ...

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 ...

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 ...

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 ...

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 ...

CFR Part 11 compliance helps companies in industries such as pharmaceutical, biotechnology, healthcare, clinical research, medical devices, and financial services keep electronic records compliant ...

SANTA CLARA, Calif.--(BUSINESS WIRE)--Agilent Technologies Inc. (NYSE: A) today announced the release of new NovoExpress software that introduces integrated compliance tools for NovoCyte flow ...

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 ...

21 CFR Part 11 (Part 11) establishes U.S. Food and Drug Administration (FDA) regulations on electronic records and signatures. In the pharmaceutical world, some of the first questions we get asked is: ...