Molecular Spectroscopy

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Spectroscopy’s “What’s Nu” newsletter in May highlights the development of lasers in spectroscopy, compensating for repack variation in near-infrared (NIR) spectroscopy, and validity by design.

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The final FDA guidance on Computer Software Assurance (CSA) was released in September 2025. This was followed by an update in Feb 2026 incorporating Quality Management System (QMS) based on ISO 13485:2016. Many proponents particularly outside of the medical device ecosystem have said that CSA will replace Computerised System Validation (CSV). But will it? Really?