Validation Built on Process Thinking

Validation:

A Profession Built on Process Thinking

Validation can often feel like just another compliance task. Fill out the forms. Check the boxes. Submit the documents. But beneath the paperwork is something much more important: true process understanding.

When I first entered the life sciences field, I brought with me a chemical engineering background. Unlike some engineering disciplines that focus on designing objects, chemical engineering trains you to design processes. You learn to think about how materials move, change, and stabilize through every step of production. That same thinking applies directly to validation.

Many organizations approach validation by focusing on the product: What is it? What does it do? But effective validation also asks: How is it made? Where are the risks? Which steps introduce variation? Which controls truly matter?

Without strong process knowledge, companies may either over-validate or overlook hidden risks. They might test the wrong things, apply the wrong level of scrutiny, or struggle to justify their validation plans to regulators.

At Brayearst, this is why process-focused thinking is central to our approach. The fully registered CAGES® Framework helps teams build clear validation strategies that combine product knowledge with process expertise. Through Validation Training & Spot Check Reviews, we support organizations in building audit-ready, risk-justified validation documentation that grows with their manufacturing needs.

Validation isn’t just about paperwork. It's a profession — and process thinking belongs at its core.

Schedule a conversation to strengthen your team’s process approach. Visit meet.brayearst.com to explore Validation Training & Spot Check Reviews customized for your stage of growth.