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Why Your Validation Documentation Keeps Failing GMP Inspections (And What to Fix First)
You stack twenty centimeters of validation documents on the conference table. IQ, OQ, PQ reports. Change control records. Validation summaries. It looks bulletproof. The inspector flips through the first IQ report, asks one question, and the whole thing falls apart. This happens more often than most pharma companies want to admit. And the confusion is real. “We did everything. We wrote every document. Why is it still not enough?” The uncomfortable truth: validation paperwork is not the same as validation compliance. For computerized systems in GMP environments, the gap between producing documents and building evidence you can defend is wider than most teams realize. The Four Traps That Sabotage Validation…


