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Featured

Andrii Yalanskyi / iStock

5 Key Elements of an Effective CAPA System
Etienne Nichols
The corrective and preventive action (CAPA) process is one of the most important elements within a medtech company’s quality management system (QMS). The goal of the CAPA system is to identify, address, and prevent systemic issues that could compromise product safety, regulatory compliance, and the overall operations of the business. Despite its importance, however, a lot of companies struggle…

Risk Management

Why QMS Software Is No Longer Optional in Regulated Industries

Many companies are still clinging to paper-based and unconnected electronic processes, despite the clear disadvantages. Without modern tools like QMS software, these organizations risk compromising product quality, falling behind in compliance, and ultimately losing competitive ground.

…

Transforming Audits With AI

For quality heads, compliance officers, auditors, and engineering leaders, audits have been a time-consuming, resource-intensive process, yet necessary to build resilient operations, prevent costly failures, and maintain competitive advantage.

The question isn’t whether to audit,…

The Ethics of Choice

In this article I’m exploring the need for ethics in systems thinking using the ideas of Heinz von Foerster and Russell Ackoff. The two come from different traditions within systems thinking. Von Foerster comes from physics and second-order cybernetics, and Ackoff from operations research and…

Why Forcing Women Back to the Office Will Cost Us Millions

As companies and government agencies push forward with return-to-office (RTO) mandates, they risk exacerbating a workplace problem that many have failed to address adequately: gender discrimination.

New research from the University of Toronto’s Rotman School of Management…

How Tech-Enabled Solutions Can Simplify BRCGS Packaging Materials

A global food safety and quality certification, BRCGS (British Retail Consortium Global Standards) initially focused on food safety but now comprises various sectors such as packaging, consumer products, and retail. It aims to ensure that businesses maintain high standards of safety and quality…

FDA Guidances on AI-Enabled Devices

As part of its effort to address the changing landscape around artificial intelligence (AI) in medical devices, the U.S. Food and Drug Administration (FDA) has recently released two new guidance documents on artificial intelligence-enabled device software functions (AI-DSF):
• “AI-enabled…

more articles
IBM Introduces Software to Unify Agentic Governance and Security
An industry-first view of enterprise risk status
82% of Physicians Question Safety and Quality of Medical Products They Prescribe
New study reveals declining confidence in regulators and an increase in medical misinformation
Rockwell Automation Launches PharmaSuite 12.00
Accelerates secure, scalable deployments
NAPT Announces Proficiency Testing Risk Analysis Module
No extra charge to the metrology community
VIAVI Launches Second-Generation RSR Transcoder
For assured PNT in GPS-denied environments
Annual ETQ Survey Reveals Widespread Labor Shortage Continues in 2025
Addressing the growing use of automation and AI
Aspiring Materials Expands to U.S. to Boost Domestic Supply of Critical Minerals
Leveraging abundant supply of olivine to deliver magnesium and nickel-cobalt-manganese hydroxides
Compliance Group Hosts Live Webinar on Digital pFMEA
Proactive manufacturing risk management and real-time alerts
LabWare Launches ASSURE
New SaaS platform comprises food product safety, quality control, and regulatory compliance
Rensa Filtration’s Advanced HEPA Filters
Certified to meet UL 900 safety standards
ATS Strengthens Workforce Well-Being Through Beyond Zero Challenge
Annual initiative promotes physical, emotional, social, and financial well-being at work
more news
      

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