Part 11 compliance is frequently misunderstood — either over-engineered into paralysis or under-implemented until an audit surfaces the gaps. Here's a grounded take.
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Regulatory & Compliance
Grounded takes on 21 CFR Part 11, ISO 17025, GxP, and other regulatory requirements as they actually play out in LIMS projects.
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Every LIMS vendor is telling you AI changes everything. After 30 years in this industry, I've learned to ask a different question: which parts are real, and what happens if you get it wrong?
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