Pharma IT Articles

There was a time when information technology (IT) professionals needed only technical skills to obtain positions in the pharma and biotech industries. Today, this has all changed. Recently, the demand for skilled professionals in pharma has been hot, and that's expected to continue as 2007 unfolds.

In today's highly competitive pharma and biotech environments, hiring managers are seeking candidates with strong technical and domain skill sets, as well as extensive industry knowledge, resulting in a much more critical eye when trying to fill crucial IT positions. But with a tight job market, hiring managers will have a hard time finding candidates with a combination of tech skills and industry expertise, and will need to wade deeper than before into the talent pool.

View Full Article

When revenue gains soften, costs start to attract greater executive attention. And so it is with Pharma. It’s widely acknowledged that the pressure to control and reduce costs is the next major challenge facing companies contributing to the Pharma industry’s global value chain. Growing generic competition, imminent patent expirations, and shorter pipelines are all contributing to eroding margins.

But as part of their efforts to improve financial performance, many pharmaceutical companies are finding it hard not to turn the cost-cutting spotlights on IT. And for good reason; not only does the Pharma industry, according to recent research, spend six times more on IT than the average U.S. industry (15% of revenues vs. 2.5%) but many companies are still waiting to chalk up measurable IT-driven business value from this huge and growing investment. It’s little wonder that pharmaceutical executives are asking why IT costs so much and yet seems to deliver so little.

Bryan L. Singer, CISSP
The adoption of open networks in manufacturing environments, and the expanding connectivity and decentralization of computer systems and databases, are making the need to secure a company's automation and production systems more important than ever. The direct linking of manufacturing systems to information systems through the presence of Ethernet on the factory-floor creates an environment where traditional information technology (IT) and manufacturing worlds collide. This trend increases the vulnerability of these systems to the same security threats facing today's IT environments. Attacks — whether direct or indirect — from hackers, worms, viruses, and employees can affect the safety and security of people, products, processes, and productivity.

This article provides practical advice for remaining in compliance with 21 CFR Part 11, the Electronic Records; Electronic Signatures Final Rule.1 It is directed at those who are responsible for maintaining this compliance. And just how do we do this? Descartes, in his Discours de la Methode, provided a clue when he wrote, “Each problem that I solved became a rule which served afterwards to solve other problems.” For our purpose, this translates to: remember how we got here and make sure we keep the momentum going.

For full Article Click Here

…this paper is to discuss a potential approach to validation for LIMS. Any effective validation exercise begins with thorough planning, based upon a sound approach.

For full text article Click Here

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

For full article Click Here

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.

For full article Click Here

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.


For full article Click Here

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.

For full article Click Here

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.

For full article  Click Here