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It's every drug- and devicemaker’s worst nightmare — inspectors coming through your front door with the power to shut you down. They're highly trained … ruthlessly committed to spotting your tiniest flaws … and tough as nails. If only you could question investigators in detail … before an inspection. Maybe you'd learn what you need to do to pass. Would they tell you? The answer is yes.
Organizations that audit device establishments must ensure that their findings document conformity, nonconformity or potential nonconformity with established best practices based on objective evidence, according to a draft standard released by the International Medical Device Regulators Forum. The GMP Letter