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The trouble is, she admitted later, the more times you transcribe, the more opportunities for mistakes Sure enough, as Bekker prepared for the audit, she discovered that in a couple of cases we had maybe made a small mistake in transcribing data, leaving out a word or fact nothing significant, she quickly said Nothing that affected the trial results But for an FDA audit, you had to come clean, to explain why the source document and official form were not identical Over the next few weeks, her staff spent the equivalent of three or four days solid working time going through the records and writing explanations of any discrepancies Then time was up Two FDA inspectors arrived, stayed about two days, and were, Bekker said, pleasant, polite, and reasonable They asked Bekker about the discrepancies, of course But Bekker had expected far worse.





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I thought that we would have to pull up more, spend more time going through detail by detail, she said, a few months after it was over It was more the psychological hype than the reality Instead of reprimanding us, they knew that these things happen The agency even had a good suggestion, to simply drop the extra template Now, having survived an audit, Bekker says that the whole concept is not such a bad idea It sharpens everyone s sense of, We cannot afford to be complacent Otherwise, human nature being what it is, standards will drop The companies regulated by the FDA in fact have a complicated relationship with their overseer Love-hate does not quite describe it.

From the industry s point of view, it is more a combination of grudging acceptance, plus fear, plus desire for a gold star that can be used in marketing, plus the natural tendency of anyone to gripe about whoever is in a posi-.

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