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Clarifying Suitability Testing: A Common Source of Misunderstanding in Regulated Assay Work

Download our technote, Clarifying Suitability Testing: A Common Source of Misunderstanding in Regulated Assay Work, to better understand the distinct roles of method suitability, matrix effect evaluation, and system suitability testing (SST) in regulated analytical workflows. This resource explains how these tests differ, where they overlap, and how they should be applied to meet FDA, EMA, and ICH requirements without duplicating efforts. It also offers practical guidance on SOP design, positive control implementation, and strategies to avoid redundant testing while maintaining full regulatory compliance.