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A Tale of Two Deviations

From two companies worlds apart in organizational culture

The QA Pharm
Thu, 05/03/2012 - 12:13
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Body

It stands to reason that pharmaceutical companies in compliance trouble also have problems with their deviation management and corrective and preventive action (CAPA) systems. After all, maintaining a good compliance profile as well as an efficient operation requires the ability to detect problems, determine the root cause, and permanently eliminate the problems.

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Good companies rejoice that a problem was detected and reward the one who detected it. It’s another opportunity to improve—one more problem that the company never has to deal with again. It rises to the challenge to find technical solutions and engineer-out the problem. The company supports its thinkers who mindfully apply their education and experience. It celebrates finding and permanently expunging recurring problems. Management is aware of, and measures, recurring problems. They have no tolerance for it and hold department managers accountable for measurable results.

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Comments

Submitted by Douglas Waterman on Mon, 05/07/2012 - 10:36

irradiate / eradicate

Nice article, it certainly seems to be quite logical, no?

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