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Featured

IMAGINE AI/Adobe 

5 Misconceptions About Generative AI in GxP Quality and Validation
Fabrizio Maniglio
Most discussions about generative AI in life sciences start with the technology. Quality professionals should start somewhere else—with the record. Our job has never been to produce documents. It has been to produce evidence that decisions were made correctly, by the right people, on the right information. Generative AI is only useful to us if it makes that evidence stronger. If it weakens it,…

FDA Compliance

Downtime Isn’t Just a Maintenance Problem

When hospitals treat device downtime as isolated, one-off incidents, they miss a critical opportunity to improve system reliability, manage long-term costs, and safeguard patient care. Downtime patterns often reveal far more than a single equipment failure; they point to the underlying condition…

Building a Connected Supplier Quality Life Cycle

A longtime raw-material supplier exits the market, and a manufacturer needs a replacement quickly. The new supplier completes a questionnaire, receives approval, and begins shipping. Months later, delivery slips and defects increase. A broad audit produces a passing score, but the problems…

Quality Is the Common Thread in a Changing Industry

Manufacturing Day fell on Oct. 2 this year. Manufacturers opened their doors and showed the public what modern manufacturing looks like, and, hopefully, built some interest in manufacturing careers.

Visitors saw robots, sensors, software, and connected production systems. What…

Securing Water and Wastewater Operational Technology Environments

Recent cyberattacks on U.S. water and wastewater systems (WWS) are highlighting the escalating threat to our nation’s critical infrastructure and the practical challenges of securing it.

These incidents underscore an important challenge: The connectivity that utilities depend upon…

A Blueprint for Keeping Humans in Control of AI

William Overman began his Ph.D. program at Stanford Graduate School of Business at an auspicious moment—just two months before ChatGPT publicly launched in November 2022, exploding widely held understandings of what machines can do.

Even as Overman began enlisting AI for his…

ISO 9001:2026 Ethics and Quality Culture

Leadership responsibility is included in ISO 9001:2026, Clause 5.1.1,  to promote quality culture and ethical behavior. A strong argument could be made for adding safety as well.

Ethics has a very wide range of applications, including the need to avoid conflicts of interest (like…

more articles
Auditors Who Got Tired of Auditing by Hand Built a Machine
Owners of capital projects can now use it directly
Danaher to Open AI-Powered Autonomous Lab
Accelerating life sciences research
Interplay Learning Launches Skill Verification to Demonstrate Workforce Readiness
New simulation-based assessments provide insights into how workers perform a task before dispatch and new-hire placement
ANSI and America Makes Help Industry Navigate Additive Manufacturing Standards
A clearer view of the standards behind safe, consistent 3D-printed parts, and where work remains
AI4RVI Launches Edgevision, an NVIDIA-Powered Remote Visual Inspection System
HDTV imaging with onboard AI for anomaly detection and report generation
Fluor Joint Venture Selected for LNG Canada Phase 2 Expansion
Project advances with final investment decision
Key Technology Introduces New Enhancements for COMPASS Optical Sorters
Delivering precise, repeatable removal of foreign material and product defects
Relay Raises $36 Million From Industry Leaders to Drive Frontline Safety, Efficiency
Investment round led by industrial leader International Paper, alongside others
New AI Technique Could Make Minimally Invasive Surgeries Safer and More Precise
Patient-specific method helps doctors use X-rays for surgical navigation in fields such as orthopedics and neurosurgery
Global Public-Private Collaboration Makes Digital Identity Standards Accessible Worldwide
Reference portal available at no cost
Trimedx Agentic AI Capabilities Reduce Medical Device Cybersecurity Remediation
Delivering up to 95% identification and matching accuracy for connected medical devices
more news

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