Medical device companies, as well as pharmaceutical makers and other manufacturers involved in the life sciences, have struggled to adapt to the rigors of maintaining electronic records and 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 ...

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 ...

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 ...

SANTA CLARA, Calif.--(BUSINESS WIRE)-- 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 ...

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 ...

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 ...

Figure 1. Economic impact of Part 11 compliance. (Click to enlarge.) Companies and organizations required to comply with 21 CFR Part 11, FDA's rule governing electronic signatures and records, are ...

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 ...

Compliant documentation in the drug manufacturing process is essential. 21 CFR Part 11 compliance software helps achieve this from raw materials to finished goods. In addition, the qualifications of ...

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

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 ...