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ISO
In today’s digital age, the question isn’t whether you’ll experience a cybersecurity attack, but when this might occur. Cybercriminals strike when you least expect it, with devastating consequences for your day-to-day operations. If your organization is lucky, it can block the attacker and limit…
Bennie Caldwell
In manufacturing, failure isn’t an option—it’s a liability. A defective part or a missed delivery triggers a chain reaction that can disrupt schedules, undermine trust, and drain resources.
So when someone suggests a strategy with the word fail in it, skepticism is understandable, because…
David Hall Rode
In 2025, there’s been a marked increase in FDA warning letters. During the second quarter of 2025 alone, the U.S. Food and Drug Administration (FDA) issued 172 warning letters. A notable enforcement surge occurred in September 2025 when the FDA released 80 warning letters in a single week. Although…
Artem Kroupenev
Quality has always been a defining metric in manufacturing when it comes to industry trust, brand longevity, and customer loyalty. Manufacturers are already expected to abide by stringent regulations. But as economic complexity rises and experienced operators retire, maintaining consistent quality…
Bryan Christiansen
From manufacturing and mining to hospitality and healthcare, computerized maintenance management systems (CMMS) have become all but essential. Wherever there are assets to maintain, a CMMS plays a critical role in reducing downtime, controlling costs, and keeping operations running smoothly.
But…
ISO
In 2021, container ships idled for weeks outside the Port of Los Angeles, a stark visual reminder of just how fragile modern supply-chain reliability had become. The backlog sent shockwaves across industries. Factories stalled, shelves emptied, and businesses scrambled for alternatives. It was a…
CANEA
The role of quality leaders, and quality itself, is expanding. It includes thinking strategically, solving problems, implementing improvements, and driving change throughout the organization.
Quality leadership also requires managing challenges and anticipating what lies ahead regarding quality…
Stephanie Ojeda
When organizations implement an enterprise quality management system (EQMS), the instinct is often to begin with high-visibility processes like corrective and preventive action (CAPA) or supplier quality. While these functions are critical, starting there can be a misstep. Without the right…
Lexi Sharkov
We’d be willing to bet your key collaborators aren’t all in the same building. Your team members, contract partners, clients, and suppliers are likely scattered across the globe. That makes collecting physical, “wet ink” signatures nearly impossible and turns digital approvals into a daily…
Lexi Sharkov
When an issue arises, it’s important to take quick action. Whether that means launching a software patch, pulling a batch, or halting the use of a reagent, it’s critical to tackle the immediate problem.
But just as critical as “How do we fix this?” is “How do we make sure this doesn’t happen again…
Walter Nowocin
Software selection, implementation, and ongoing maintenance are critical stages in the life cycle of biomedical software systems such as asset and calibration management platforms. Yet few industry resources provide detailed, practical guidance for managing these processes effectively.
One notable…
Mike Regan
In July 2024, CrowdStrike rolled out a software update that crashed more than 8 million Windows systems worldwide. The faulty release disrupted hospitals, grounded flights, halted banking operations, and affected government services. Comparable to a major cyberattack, the incident caused more than…
William A. Levinson
A vital concept from the chemical process industry, management of change (MOC) relates primarily to safety. It means that whenever we change a factor in a cause-and-effect diagram (e.g., machine, material, manpower, method, measurement, environment, or any other factor), we create risks of…
Cindy Mielke
Over the years, there have been many developments in systems and technologies that have helped industries redefine how businesses are structured. These changes, especially in sectors like manufacturing and distribution, have led to new roles and responsibilities for employees.
However, often with…
Jake Walton
Imagine you’re a student trying to pass a challenging class, one where the entire grade rests on the big test at the end of the semester. Fortunately, the professor handed out a syllabus that outlines exactly what will be on that final exam. Better still, you can also find a posted list of common…
ISO
Security configuration management (SCM) is a critical concern for organizations and a fundamental part of many cybersecurity frameworks. Consider this scenario: A team member tweaks a hardware setting on their personal laptop to boost software performance. However, this change causes unforeseen…
Lexi Sharkov
They may seem simple, but SOPs (standard operating procedures) are surprisingly tricky. On the surface, they describe how a specific process is carried out at your organization. Pretty straightforward, right?
In reality, there are a lot of requirements for writing a good SOP, and auditors have a…
NIST
A rapidly growing category of drugs called protein-based biotherapeutics can be used to treat cancers and genetic and autoimmune disorders. These drugs, which usually take the form of large protein molecules, are manufactured by growing living cells that are genetically engineered to produce the…
Stephanie Ojeda
Global-scale events have tested the bounds of supply chain systems. The coronavirus, for example, made it clear how critical an efficient supply chain is for continuity and survival. It’s a real-world example of how important it is to have an enterprisewide system that uses a quality management…
Nimax
Pharmaceutical serialization practices are on the rise and have progressively become a worldwide standard as a result of stringent regulations in various of markets, including the United States, European Union, China, and Argentina. Recent estimations found that by 2022 serialization practices had…
Etienne Nichols
Good supplier management is one of the most important methods of building a safe and effective medical device. A single device may be made up of dozens of parts and components coming from several different suppliers, and many medical device companies outsource the manufacturing of their device to a…
Akhilesh Gulati
Complacency won’t show up on a control chart. But its damage is real. Can AI and systems thinking help us detect it and respond before trust is lost?
As customer expectations evolve, one question remains: Are customers still at the core of your company’s operations?
Back in 1999, a simple but…
Hexagon Manufacturing Intelligence
Did you know that shutdowns, turnarounds, and outages (STOs) can consume up to 50% of a plant’s annual maintenance budget? That’s according to a report by the Boston Consulting Group.
STOs are among the most complex and high-stakes events in industrial operations. They’re costly, especially when…
Bryan Christiansen
Facility teams are constantly balancing urgent repairs, preventive tasks, asset tracking, and compliance, all while ensuring smooth day-to-day operations. But when processes are manual, fragmented, or unclear, even simple tasks can spiral into delays, miscommunication, and wasted time.
The…
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…