Pharma IT Articles

Not just a quick fix, e-procurement requires a thoughtful and thorough approach to produce the most rewards.

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I n Part I of this article, the authors discuss FDA expectations, specific requirements, and validation plans of networked systems and include a glossary of related terms. Part II will address the types of specifications, the installation, testing, and implementation of required validation for networks.

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The fundamental objective of testing is to prove some assertion. This sounds so obvious as to be silly , but the biggest cause of ineffective testing I have seen is the loss of clarity of this objective.


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Determining whether a data point is an "outlier" — a result that doesn't fit, that is too high or too low, that is extreme or discordant — is difficult when using small data sets (such as the data from three, four, or five conformance runs). The authors show that the Weisberg t-test is a powerful tool for detecting deviations in small data sets.

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How many of you have validated Programmable Logic Controllers (PLCs) or computers in the past? How many of you are going to have to do it again? And how many of you think that it is an awful, complicated, and terrible thing to have to do? If the answer is "Yes," I used to feel that way as well.
My first experience with PLC validation was absolutely awful; I knew there had to be a better way. I knew that it had to be much easier than I had made it and that I could somehow communicate that to others.

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Applied Clinical Trials, Mar 2, 2003

As discussed in the companion article in last month’s issue of BioPharm, many needs of pharmaceutical development and manufacturing, from excipients to contract laboratory services, increasingly are being purchased through e-procurement processes (1). o­ne such process, the o­nline reverse auction, allows buyers to exchange information with sellers and solicit and accept bids from multiple sellers in a Webbased electronic marketplace.

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Bridging the gap between compliant spreadsheet production and limitations in available technology can be achieved by the use of custom-created electronic solutions.

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Like all new technologies, the potential benefits of Linux also carry risk for pharmaceutical developers.

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Fail more often and fail faster. Pharmaceutical companies are increasingly realizing that the key to a successful product pipeline is eliminating the inevitable unsuccessful products as quickly as possible. And in the pursuit of failure, the most powerful tool is information. The massive commercial databases that contain terabytes of information — including the entire human genome — ought to make it easier than ever to eliminate dead ends. But there’s just o­ne problem: Every year large pharmaceutical companies spend billions of dollars o­n R&D o­nly to scrap hundreds of products that don’t pan out. The “what if” results that can kill a drug before it reaches clinical trials often show up o­nly after years of development. Until recently, 15 years was not uncommon. So the sooner researchers can see the endgame in their data, the better.