When Validation Crosses Categories

Validation Is About Process, Not Just Product

When I worked in medical device manufacturing, we made cell culture media. Our customers were pharmaceutical and biologics companies. Their products were classified as drugs. Ours were classified as medical devices.

But as I went through audit after audit, sometimes two in a single month, I started to notice something important. Even though the end products were labeled differently, the validation expectations were nearly the same.

Why?

Because the process steps were the same:

Blending. Refining. Packaging. Labeling. Testing.

No matter what the label says—drug, device, or biologic—the work of validation happens in those process steps prior to sale. It does not matter if the product will be swallowed, injected, or used in a diagnostic kit. What matters is whether the process that made it was consistent, well-documented, and proven to be capable.

This is where many life sciences teams get stuck. They are told to follow industry-specific guidance but are not taught how to adapt those guidelines to their actual technology.

That is why I talk about validation as a process-focused discipline. It is how we build credibility, not just compliance. And for smaller teams especially, this mindset can make all the difference in scaling safely and sustainably.

Ready to rethink your approach?

Schedule time at meet.brayearst.com to talk about strategies that fit your process, not just your product.