When AGILE may not work
<p>Example? Pharma industry. In the US it’s regulated by <a href="http://www.fda.com/" rel="noopener ugc nofollow" target="_blank">FDA</a> (Food and Drug Administration), in the EU by <a href="https://www.ema.europa.eu/en/homepage" rel="noopener ugc nofollow" target="_blank">EMA</a> (European Medicines Agency) etc. They control a lot of the aspects of R&D (Research and Development), Manufacturing, Supply etc. And when I say “control” I mean that they have a list of recommended practices (related to documentation, organization of employees’ daily routine, segregation of duties and so on and so forth) which companies selling products on certain territories must follow and they can inspect them any time to make sure that everything is done in accordance with their codex. If not, many bad things can happen: penalties, products calling off from shelves, reputational damages, prosecution, you name it. The reason for that is clear: one mistake in formula or wrong temperature regime during distribution and you can get a poison in your vein instead of a medicine.</p>
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