Standards
When you go to a medical appointment, does the doctor look at you while you talk? Or are they busy typing everything you say into a computer? If it’s the latter, you may find that will change soon, thanks to artificial intelligence.
Some doctors’ offices are using AI services to…
In recent months, through several of my professional activities, a recurring and increasingly concerning pattern has emerged: The use of AI to generate client responses to accreditation assessment findings (nonconformities) as well as participant essays, exercises, and examination answers from…
During a June 2025 webinar on pragmatic AI applications in healthcare quality management and regulatory affairs, live polling of quality and regulatory professionals revealed that approximately 80% of respondents were actively implementing AI solutions or seriously considering their use in…
The medical device industry is counting down to an important deadline: On Feb. 2, 2026, the U.S. Food and Drug Administration’s new Quality Management System Regulation (QMSR) formally replaces the Quality System Regulation (QSR).
Although the full text of the QMSR has been…
If you’ve flown in the U.S. in recent years, you’re probably familiar with the airport security experience of entering a booth, raising your hands above your head, and having a machine check your body. That machine is called a millimeter wave scanner.
I’ve done this many times and…
Increasingly, inspectors for the U.S. Food and Drug Administration (FDA) will evaluate your CMMS provider’s security controls—not just your internal procedures. In a cloud-hosted GxP environment, data doesn’t stop at your firewall; your vendor’s security posture becomes part of your compliance…