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.

My June 2025 article, “How to Avoid FDA Warning Letters,” points out that inadequate corrective and preventive action (CAPA) is a major reason

I had a great conversation with a friend of mine. He was bemoaning the fact that his company was almost completely dependent on one huge customer. He saw the inherent risks in that relationship but confessed that his organization had a bad habit it couldn’t kick.

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.

Ninety days to implementation vs. 12 to 18 months with traditional systems: That’s not just an incremental improvement—it’s a complete reimagining of what’s possible in life sciences quality management.

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.

Today, manufacturing is largely shaped by supply chain volatility, complex labor dynamics, and—like most global industries—the rise of AI.

Simulations still can’t predict precisely when an earthquake will happen. Still, with the incredible processing power of modern exascale supercomputers, they can now predict how they will happen and how much damage they will likely cause. 

Software selection, implementation, and ongoing maintenance are critical stages in the life cycle of biomedical software systems such as asset and calibration management platforms.

What if your quality system could detect and initiate corrective actions for equipment deviations before they affect product quality?