All Features
Scott Crow
W ithin the utility industry, regional entities increasingly focus on internal controls as a measuring stick for overall compliance performance.
Developing and executing rock-solid internal controls with an automated compliance management software solution can help maintain compliance, not only…
Rob Moorey
Biomedical equipment technicians (BMETs) are facing increased workloads and staffing shortages that are expected to get worse as the current workforce retires.
About one-third of healthcare technology management (HTM) professionals are older than 55, putting pressure on health systems to attract…
ISO
Modern-day security breaches, such as the SolarWinds or T-Mobile attacks, aren’t one-off events; they are prime examples of how someone can steal your organization’s credentials and use them to gain illegitimate privileged access to sensitive assets. Data breaches happen daily, and in too many…
Harish Jose
In this article, I’m looking at Weber’s Law. It’s named after Ernst Heinrich Weber (1795–1878), a German physician who was one of the pioneers of experimental psychology. I highly recommend the Numberphile YouTube video that explains this in detail.
A simple explanation of Weber’s Law is that we…
Steve Ilmrud
As we approach 2025, one of the most pressing challenges manufacturers face is a growing labor shortage. Research anticipates that 1.9 million jobs will go unfilled during the next decade. This issue, compounded by the retirement of experienced workers and the lack of interest from younger…
James Chan
Asset maintenance isn’t just about fixing things when they break. It’s a complex mix of strategies, both proactive and reactive. Finding the most cost-effective blend makes all the difference in the success of your maintenance program and your business as a whole.
Whether your team is scrambling…
ISO
Cybersecurity has become increasingly critical in the digital age as organizations across all sectors face growing threats from cybercriminals.
Imagine that hackers breached a small healthcare practice through “phishing”—sending a scam email and gaining access to sensitive patient data, including…
Julie Gowthorpe
Management goals commonly include maintaining harmonious work environments that make employees happy and motivated. But how do you achieve this when people don’t get along? “Sort it out on your own” is no longer an option when employees are in conflict. As teams grow and experience turnover, a…
ISO
ISO and the United Nations Development Program (UNDP) have unveiled the world’s first international guidelines to help businesses and organizations expedite their contributions to the U.N.’s sustainable development goals (SDGs).
New guidelines for urgent action
The ISO/UNDP guidelines for…
Thierry Mantel
Metal cold-rolling is a critical process in manufacturing various steel and aluminum products. As manufacturers look for ways to modernize and streamline their manufacturing and quality control processes, digital technologies are poised to transform the metal cold-rolling industry by offering…
Stephanie Ojeda
How can a quality manager secure stakeholder engagement and hold individuals accountable for the quality of their work throughout the corrective and preventive action (CAPA) cycle?
With the burden of quality and compliance on their shoulders, it can be tempting for a quality manager to gather…
Seb Murray
Last year, the corporate world adopted a new term: flattening. This refers to how tech companies, which rapidly hired droves of middle managers during the pandemic boom, are now eliminating this layer through widespread job cuts.
Recent research by Mustafa Dogan, Alexandre Jacquillat, and Wharton’…
James Chan
The U.S. Food and Drug Administration (FDA) is the country’s chief agency for regulating the manufacture, marketing, and distribution of critical consumer goods including food, cosmetics, medical devices, biological products, and pharmaceuticals. The FDA provides direct oversight of the businesses…
Nadav Klein
When conflicts in a team, no matter how minor, are left unresolved, they can eventually breed resentment. If unaddressed, this could lead to cynicism and distrust, as well as harm to individual and team performance. How should leaders deal with this?
The intuitive answer might involve…
Jennifer King
Many people don’t realize just how long AI has been around in the healthcare industry—and are surprised to find out that it’s something that’s been relied on for 50 years already.
MYCIN, a computer-based model with machine learning capabilities, was developed by a team of researchers at Stanford…
Michael Platt, Vera Ludwig
Four years after the Covid-19 pandemic accelerated remote work, its advantages and drawbacks have been well documented. For leaders, the biggest hurdles have remained constant: building employee engagement, trust, and communication.
Nano Tool
Scientists from the Wharton Neuroscience Initiative …
Robyn Coward, Brian Brooks
This year, the Medical Device Innovation Consortium held an Excellence in Quality Summit where it was promised that participants would receive a “unique opportunity to learn adoptable cutting-edge practices to maximize the impact of investing in quality across [their] total product life cycle.”…
John Tschohl
Are your employees empowered to make decisions on the spot in favor of the customer? Your single goal should be to have overly happy customers. Too many things go wrong each day. You want your employees to understand they are in customer service, and their No. 1 responsibility is to take care of…
Touradj Ebrahimi
For the last 30 years, the JPEG image format has been a staple for the internet’s billions of users. While the technologies used to display images have evolved tremendously during the past few decades, the JPEG format is still used everywhere. This is a great example of what can happen when a new…
John Hilgendorf
Whether you’re an executive with limited energy or an hourly employee trying to minimize work, the bottleneck in your productivity isn’t time or money but mental effort. And in a digital age where all data can be stored electronically, the most valuable functions of software—especially those in…
Mike Figliuolo
Reading the news (or even your email) can be distressing to the point of despondency. It can also be fun. It’s especially fun when people say or write silly stuff, and the reporter or editor has to write [sic] after a misspelling or a stupid comment in the original transcript. Sic, usually placed…
Etienne Nichols
On Jan. 31, 2024, the U.S. Food and Drug Administration (FDA) released its final rule for the new Quality Management System Regulation (QMSR).
The new QMSR is the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s quality system regulation (QSR) with the…
Stephanie Ojeda
There’s no question about it: Should an auditor or inspector visit your facility, one thing that will certainly be under the microscope is your corrective and preventive action (CAPA) system.
CAPA management is a recurring theme in U.S. Food and Drug Administration (FDA) warning letters, a fact…
George Schuetz
In this job, I get a lot of questions. In fact, I did some figuring the other day and estimated, conservatively, that we have probably answered at least 50,000 gauging questions over the past 35 years or so.
Some of these questions have been challenging. They’ve pushed me to learn more about my…
Chris Rush
Ensuring the accuracy and security of clinical data, as well as compliance with good clinical practice (GCP), will in large part determine the success of your study and regulatory submission to the U.S. Food and Drug Administration (FDA). Data management and reporting are essential practices when…
