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"The observed lapses, including but not limited to laboratory controls, documentation practices, and data integrity controls indicate fundamental weaknesses in the QUs oversight function." FDA Warning Letter, SV Labs Corporation, 2025 It may come as a surprise, but most of the citations arise from the mundane best practices that labs know they need to do but struggle with when managing data manually: good record-keeping, data hygiene, role-based access, and so on are nearly impossible with paper-based or spreadsheet systems, but come built into most cloud-based software platforms

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