Let’s start with a definition of Industry 4.0, keeping in mind that we’re rapidly approaching Industry 5.0. Industry 4.0 is an era marked by enhanced digitization and the increased connectivity of smart technologies.

On Feb. 23, 2022, the U.S. Food and Drug Administration (FDA) released its proposed rule for the new Quality Management System Regulation (QMSR).

Since 2010, citations for insufficient corrective action and preventive action (CAPA) procedures have been at the top of the list of the most common issues within the U.S.

Amedical device company is expected to deliver innovative, life-changing devices while ensuring compliance and achieving true quality. This task bears loads of responsibility—all of which must be kept and documented within your quality management system (QMS).

Design controls are a frequent citation in 483 observations and warning letters from the U.S. Food and Drug Administration (FDA). In fact, the agency has noted a large proportion of past recalls that could have been prevented with design controls.

Medical companies work in an environment of ever-increasing challenge and complexity. Global regulations continue to evolve with advancements in technology and variations in requirements from country to country.

The levels of contaminants in our food supply are, generally, decreasing. That’s the good news.

Change of any kind often requires a catalyst. This is particularly true in a business environment where the rule of thumb is to do things the way they’ve always been done.

Life science organizations depend on quality management systems (QMS) to improve products, minimize risks, ensure patient safety, and support regulatory compliance.

I have a bold opinion: The corrective and preventive action (CAPA) process is the second-most important component of your quality management system (QMS). (If you want to know what I think is No.