Re: Sarbanes-Oxley
And I respond that the original assertion is not incorrect and that Peter, while not incorrect either, may have misunderstood.
With Big Government Regulations (BGRs) (the FDA's QSR is one I'm most familiar with, but I'll bet SOX follows the same model, as does the tax code), there are many levels of interpretation interposed between the letter of the act and the practice on the ground.
I can respond, with knowledge, having spent approx. 37 years interpreting the tax code and regulations. It is important to understand the regulatory purpose for any law. for example, the tax code was designed to raise revenue, the Food and Drug law to protect the health of the populace. However, lest I stray too far from tech writing, there can be great difficulty when someone follows the letter of the law. As soon as one does, if it works to the taxpayer's favor, a new layer of interpretations is imposed, or laws enacted, to attempt to close the loophole. When the new layer comes down, there is a 90% chance that it will open up new layers of complexity and new loopholes. The compliance writer must, as you say be careful that the version produced is the most current.
<snip>
Second, nothing in the "final guidance" is a hold-harmless clause. You can follow it to the letter in everything you do, but this does not guarantee that you have complied with the underlying Act and that you cannot be fined administratively for violating it or thrown in jail, either. So you have to know the back story, bring in insider consultants, and pay your own lawyers a fat retainer to review your practices and keep your backside out of the hot bacon grease.
Reasonable interpretations based upon the advice of counsel, when there is reason to rely on such advice, will not, (no make that should not,) result in filing criminal charges. However I do not think that general practice in the industry is not by itself, a valid excuse for non-compliance. (But officer everybody was doing 90 mph in the school safety zone.)
Third, none of the BGR documents actually spell out what you are supposed to do. They provide standards against which inspectors are expected to judge your behavior, but they don't tell you what the content of form of your documentation is actually supposed to consist of. The object is not to micromanage every company in every industry but to hold up a yardstick against which your behavior is measured.
That is precisely why they want experience. It takes a good amount of business judgment, of the kind not recorded in any textbook, combined with the knowledge of the red flag phrases and ow not to use them, while remaining in compliance.
--
Peter (aka loophole)
Sisyphus had it easy
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References:
Re: Sarbanes-Oxley: From: Andrew Plato
Re: Sarbanes-Oxley: From: Peter
Re: Sarbanes-Oxley: From: Dick Margulis
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