FDA Compliance
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.…
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…
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…
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…
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…
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…