New process is qualitative rather than quantitative
Computer system, cutting corners, self-certification all play a part
Stop fighting the auditors and get back to basics
Here’s a sample of some of the stories our readers found most interesting in 2019
Complete all 11 quizzes, and you will have satisfied the requirement in 21CFR211.25(a) for continuing CGMP training
Want to be part of FDA’s SaMD precertification program? Get your QMS up to par.
Standards under development seek to make AI practical for more settings
Future systems start with documentation hierarchies but focus on electronic process documentation
Producing safe food doesn’t just make sense. It’s the law.
We already have the tools, knowledge, and monetary incentive to address environmental issues
Halting the rollout of AI is not an option
Creating a culture of champions
Six common mistakes and how to avoid them
Three steps to enterprisewide clarity—and efficiency
Many of IATF 16949’s key clauses are relevant to nonautomotive applications
How manufacturers can best prepare as the FDA moves to adopt ISO 13485:2016
A third standard has just been published in this series
The agency seeks to balance expedient exemptions against public transparency about medical devices
European MDR update: Lowest risk medical devices must comply by May 26, 2020
Understanding the changes