Re: FDA and Offshore standards



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Charles Waite (waite(at)waterw.com)
Fri, 4 Oct 1996 16:47:57 -0400


Nancy wrote: "I don't understand why this should be scary. Why is it any different than looking it up in a book? The book might even have been scanned into the computer or, as is the case now, probably written on the computer. So what? Given that it is easier to store a computer than an entire library in a doctor's office, this seems to be an advantage. What is the risk over what we used to do?" On the face of it, it would appear Nancy has a point, but there are issues beyond just putting a book onto a computer. I have recently performed work for two clients who are instituting "document management systems." The biggest problem I have found is ensuring that the "right" document is the one being read. Unfortunately, lab procedures can change as fast as PC micro-processors. Has the lab maintained configuration control over the data on the computer? Have backups (assuming we're talking about volatile storage) been made? Are the reagents being used the ones for which the procedure was tested? Does the technician have a clue? Obviously, many of the same risks apply to books. But books can be written in. Notes indicating steps that didn't work can be physically inscribed. And while not quantifiable, computers are still looked at as machines that give answers by a large segment of the population. If the software has presented the wrong procedure because the technician hit the wrong key (next document versus next page), is the technician prepared to question the result. Bottom line, I agree with Nancy in suggesting the same risks may apply to paper and computer media. So perhaps the risks lie outside the computer, but they are risks none-the-less. Charles Waite Kemper-Masterson, Inc. c/o 38 Fox Run Mount Laurel, NJ 08054 (609)235-4275


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