I was browsing topics on astm.org and stumbled upon something I never thought I'd see. Most standards discussing process validation for medical devices use three terms: installation qualification, operational qualification, and performance qualification. For over 20 years, I've been practicing, training, and mentoring in validation activities. And I've never been comfortable with the inconsistency in the parts of speech used. But today, I finally found someone who feels the same way. The title for the additive manufacturing process validation standard uses the terms installation, operation, and performance.

 Had enough of tongue-twisting terminology? Let's start a movement for clear, consistent validation speak! Who's with me? Share to join the crusade!

About Brayearst Validation Consulting

Brayearst Validation Consulting leverages Six Sigma methodologies to provide targeted validation services for the life sciences industry. We specialize in process, cleaning, software, and analytical test method validation, ensuring compliance with FDA requirements while optimizing operations for efficiency and quality. Our team combines technical expertise with a deep understanding of regulatory standards to deliver process-driven validation documents that withstand rigorous auditor scrutiny. From strategy development to study execution, we empower our clients to achieve operational excellence and bring high-quality products to the market with confidence.