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Magnus Jahnsson [8], the indirect impact level doesn t add any value to the assessment, so the only two levels that are relevant are impact or no impact. There is always the question of how many levels of risks should be de ned. In the examples below, three levels are used: high, medium, and low. It is possible to have more, but then the question of de nitions is hard and will lead to long discussions. Only advanced risk assessors should use more than three. A four-level division will give too many options, and the nal result won t be very different from the three-level division. Figure 12.2 shows one company s identi cation of risks and how it de nes its four-level seriousness/impact scheme. The company has included four risk types (technical goals, regulatory requirements, cost, and project plan) in the assessment. Identify Product/Process Risks This step is the determination of whether the system function or subfunction represents a risk when assessed against a series of GxP criteria. Regardless of whether your organization is a production or laboratory facility, the same risks are still present, even if the focus may be more on results or customers than on patients. Unidenti ed risks in a forensic laboratory can have serious consequences: people who may end up in jail due to unidenti ed and/or unmitigated risks. Create your own list, to include your organization s functions and potential risks. It is easy to see from the list below that computerized systems are involved in several of these processes. Examples of risks that may be identi ed include, but are not limited to, the following: r The pharmaceutical quality of the nished product (including clinical supplies): incorrect composition raw material errors

We wish we could give clear advice Stocks are cheap, so it s time to go all in or The economy is getting worse, so sit in cash but we can t because we don t have a strong feeling about what the market s going to do We re nding quite a few exceptionally cheap stocks to buy and we obviously have a great deal of conviction about what we own, but we ve had so many unpleasant surprises that we ve become very cautious It s very hard to differentiate between the handful of genuine, safe, pro table value opportunities and the many deadly value traps in today s markets.

Our applications grow more complex every day, with endless evolving topologies, heterogeneous hardware platforms, shrink-wrapped vendor solutions, black box run-time environments, and third-party extensions, plug-ins, add-ons, and more. After going through all the trouble of verifying that the system works, how do we protect it as it evolves and as new releases of software and new downloads of information are pulled into its architecture This problem is very hard. The common strategy to solve this problem is to pretend that it does not exist. In this chapter, we have described some mechanisms for enabling trust, distributing active content, using digital intellectual property, and relying on our ability to read code to trust programs. The architectural pattern that we have repeatedly attempted to emphasize is that enabling trust involves the creation of structure within and without an application, the creation of policy, and the definition of trusted third parties.

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We think this economic crisis is unlike any we ve experienced in our lifetimes and it will turn out to be the most severe economic downturn since the Great Depression (though we don t think things will get anywhere near that bad, so let s call this one the Great Recession) Thus, while we wouldn t bet on much more downside for US stocks in general, we wouldn t bet on much of a recovery, either, for quite some time In light of this uncertainty, our main advice is that you don t have to be a hero by calling the bottom on the market or a particular stock Pretty much everyone who has tried to do so has been taken out on a stretcher by this brutal market Instead, be cautious and humble, make smaller bets than usual, and be ready to admit mistakes and change your mind.

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