All Features
Aity Ritesh Raj
FDA inspectors don’t just check your records. They bring their own thermometer.
And when their reading doesn’t match six months of logged data from the sensor on your cold room wall, the honest explanation is one nobody wants to say: The monitoring system was compliant; the measurement just wasn’t…
David Isaacson
Quality Digest recently spoke with David Isaacson, the executive director of portfolio marketing at Octave. Besides his work on marketing strategies, he also helps people manage, understand, and better control their operations with software solutions that protect industry assets and people while…
Seb Murray
Industrial robots don’t just shape pay today. Research from Pinar Yildirim, a Wharton professor of economics and marketing, shows they also make workers less likely to move into higher-paying occupations, cutting expected lifetime earnings.
“Workers aren’t necessarily losing their jobs, and it…
Patrick Gale
Hospitals continue to face increasing financial uncertainty as healthcare reimbursement rates shift and margins tighten.
Medicare reimbursed hospitals at just 83 cents on the dollar in 2024, driving more than $100 billion in underpayments. At the same time, rising labor, supply, and technology…
Arysha Alif Khan
Chemical manufacturing employs roughly 500,000 people in the United States. According to the Bureau of Labor Statistics, workers in that sector noted a total recordable incident rate of 4.2 in 2024, compared to the all-industry average of 3.2. That’s a 32% gap, and it has resisted decades of…
Takeisha Wright
A CAPA investigator opens an AI-enabled quality management system and asks for potential root causes. The system produces several plausible explanations, summarizes similar historical events, and recommends corrective actions. The investigator reviews the suggestions, selects one, and closes the…
Etienne Nichols
The U.S. Food and Drug Administration’s April 2, 2026, warning letter to Purolea Cosmetics Lab is making the rounds, mostly under some version of “FDA cracks down on AI in manufacturing.”
That’s the wrong way to read this. If you build medical devices, treating this issue as an AI story will cause…
MIT News
MIT launched a new initiative—titled Science Is Curiosity on a Mission—to make the case for the long-horizon, curiosity-driven science that has powered generations of American innovation. Through stories of scientists pursuing open-ended questions, the project highlights how fundamental discovery…
Pramin Pradeep
Here’s a scenario that should make any quality leader in pharma or medical devices uncomfortable: A software team building a diagnostic support tool uses an AI coding assistant to generate a data-processing module. The module looks correct, passes validation testing, and ships. Eighteen months…
Quality Digest, Josh Santo
Josh Santo, senior director of industry strategy and solutions at EASE, spoke more about the findings behind a full layered process audit (LPA) benchmark report of plant-floor quality audits. Data covered 2.3 million process checks spanning more than 2,200 manufacturing sites. The report not only…
Paddy McNamara
The food manufacturing industry has spent the last two years trying to figure out where AI fits: Vision inspection systems? Predictive maintenance? Yield optimization? Contamination detection? The applications are real, but they’re expensive, technically complex, and often require significant…
Chengyi Lin, Michael Lee
Many leaderships teams staring down the barrel of organizational transformation face a similar dilemma: How do you take a leap into the unknown when there are no clear data, no well-trodden path to follow, and no assurance of success? What if the change you’re considering is uncharted territory,…
Jeff Dewar
Our video producer Chris Smith almost watched the Artemis II launch in person. He drove to Kennedy Space Center with all his fancy gear, along the way got stuck in the snow twice—in Texas, of all places—and then NASA scrubbed the launch and rolled the rocket back for repairs. So Chris drove back to…
Kiran Myalur Dharmaputhra
Corrective and preventive action (CAPA) is the backbone of any quality management system. It’s where problems get solved, risks get reduced, and processes become more robust. Yet in many organizations, CAPA has become little more than a documentation exercise.
Forms get filled. Boxes get checked.…
Andy Addington
Three years ago, I’d never heard the term biomedical equipment technician (BMET). I didn’t know the field of healthcare technology management (HTM) existed. Today, I’m a BMET II responsible for making sure critical medical equipment is available and safe for patient care. It’s incredible to look at…
SoftExpert
Digital transformation has stopped being a trend and become a condition for competitiveness. In practically every sector, including manufacturing, automotive, food and beverage, healthcare, and logistics, the pace of technological change is redefining what it means to manage quality with excellence…
Cooper Schorr
The era of the unlimited, always-on, general-purpose AI agent is ending. Subscriptions weren’t priced for behavior that never sleeps, and a monthly plan burning thousands of dollars in computation was never going to survive the unit economics.
If you’ve tried to get an AI pilot past Phase One,…
Lily Fang
Software is eating the world, venture capitalist and entrepreneur Marc Andreessen famously declared in 2011. The ensuing 15 years proved him prescient. In February 2026, a Substack article by Citrini Research grabbed headlines and triggered a market sell-off of SaaS (software-as-a-service) firms,…
Stephanie Ojeda
Growth has a way of outpacing the quality systems built to support it: more products, more sites, more users, more regulatory requirements, and the quality team is expected to absorb all of it.
Document reviews stall waiting for approvals. Training assignments require constant follow-up. Approval…
Jake Walton
Nobody would get into a self-driving car simply because the door locks worked and the alarm system was functioning properly. Those security features protect the car from being stolen or tampered with, but they say nothing about whether the car’s AI will stop in time when a child runs into the road…
Matt McFarlane
It can be surprisingly difficult for businesses to get accurate answers to questions about their own data. Often, the data live in different systems or aren’t easily accessible to employees without specific technical skills. Some data may be in Salesforce but not in the company’s content management…
Scott Ginsberg
At Dozuki, our teams are constantly on the factory floor. We spend hundreds of hours every year walking production lines, sitting in breakrooms with operators, and standing alongside quality managers during high-stakes audits. These site visits have given us a front-row seat to witness the friction…
Mike King, Massimo Franza
‘This product isn’t approved to be imported into this market,” says a customs official while reviewing the importation documentation.
Local quality and regulatory teams are quickly brought into the conversation and see that the product’s registration has been valid for several years, and no local…
Lisa Morris
AI adoption in medical practices is growing steadily, with most providers seeing positive ROI. But progress depends on overcoming integration, skills, and trust barriers to focus AI where it delivers real clinical and operational support.
As the healthcare industry continues to embrace digital…
Greg Rankin
For decades, the process industries have relied on layers of protection to prevent hazardous events. When risk reduction requirements were high, safety instrumented systems (SIS), governed by standards such as IEC/ISA 61511, provided a clear framework for design, operation, and life-cycle…