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Paula Suliga
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Join date: May 15, 2024
About
Paula is a curious and open-minded scientist, determined to achieve compliance objectives and provide a best-in-class customer experience. She has professional experience in both the Life Sciences and Information Technology fields, blending expertise from both domains to drive innovative solutions.
Posts (2)
Jul 7, 2026 ∙ 7 min
Commissioning, Qualification, and Validation in Life Sciences: What's the Difference
Commissioning, qualification, and validation are three distinct activities in GxP environments -- each with different purposes, regulatory expectations, and ownership. This article breaks down the differences in plain language, with a practical example, a quick reference table, and the most common mistakes to avoid.
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May 15, 2024 ∙ 5 min
Differences Between Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD)
Learn about SaMD and SiMD: What they are, how they're regulated, and why they matter for medical devices.
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