MAKING ITS EASY

In January 1998, 'Young and Rom formed IntralogiX using private funding The idea for the company is quite straightforward: Present all the relevant technical information for a wide variety of chromatography columns (GC, LC, capillary electrophoresis [CE] and size exclusion chromatography [SE]) from all vendors in one place, making it easy for chemists and purchasing agents to find existing alternatives to a particular column. Often chemists are aware of only one column for an application, either due to inertia or because that column, especially denoted during the method development and validation.

Column manufacturers will tell you that much of their business come from repeat customers who, after validation of a method, are not allowed to change or upgrade the column. However, many chromatography applications are not under such strict controls, and, new column technology or some reasonable alternatives should be considered. This customer is the ideal candidate for Intralogix.

When you first log in to the Intralogix site, you are asked to set up a member profile that includes your name, title, mailing address, e-mail address, and the disciplines you are particularly interested in (e.g., chiral columns, gel permeation chromatography, ion exchange). The information in your profile the system to deliver a very useful, personalized product update every time you log in (personalization seems to be a key differentiator among Web sites these days). Addenda to the print catalog are ( available online, as are any product changes, updates, and technical notes All notices are deleted automatically thir ty days after posting.

In the normal search part of th screen, you can search by part number, trade name, or part of either. For example search for "255-55" brings up Hypersil ODS 120 column -with thah part number. When you click on the hypertext link for this part number, all the relevant technical information for this column is presented, including complete specifications in either a document format or Adobe portable document format (*.pdf), so the sheet can be printed exactly as laid out by the manufacturer, including example chromatograms.

The technical specifications for most products are put into a common format for easy comparison, and some column manufacturers supply Intralogix with additional material. What is remarkable and extremely useful about this database is that it automatically gives you all the similar columns from other vendors (eleven in the Hypersil ODS 120 case), including fist prices. So in essence, just by knowing a part number or something characteristic about a column, the comparison is automatically generated with an absolutely minimum amount of knowledge (and effort).

When the database is used more fully, a wide variety of selection criteria is available. LC columns are divided into HPLC, chiral, ion exchange, and GC/SEC; GC columns are separated into regular capillary and chiral. There is also a CE/capillary electrochromatography selection. Once into a particular category, perhaps HPLC columns, the criteria for sorting and selecting are very extensive. For LC columns, you can specify phase class (eg, C8, C14, cyano, or wax), pore size, any special characteristics, base material (alumina or polystyrene), particle size, carbon loading percentage, end-capping characteristics, inner diameter, and USP code.

The Intralogix search engine is flexible enough that you can select perhaps three pore sizes, two base materials, and three particle sizes. Once a search has been done and the particular columns have been selected, it is simple to compare them in detail. You can select perhaps four or five of your top choices for a further comparison, and then each of the columns is compared side by side, with all the technical details.

Chromatography columns are a natural for this kind of comparison shopping, because there are many suppliers and because several technical specifications are needed to really match one column with another (the Intralogix site contains an address book of almost forty suppliers of chromatography columns and supplies). Even then-as experienced chromatographers are quick to explain-the columns might not be exactly equivalent when subjected to the real test: the crucial separation in your laboratory.

Just who is the prime audience that Intralogix is trying to reach with this service? Obviously, the major purchasers of chromatography columns-chernical and pharmaceutical companies such as Abbott, Procter & Gamble, Pharmacia, and Upjohn-are likely candidates, as are large government labs and research institutes. Can this use of the Internet for comparison shopping be expanded in the future, perhaps to scientific instruments, chemicals, or software? That's what the people at Intralogix are thinking. Perhaps other categories will be added, but it will be much more difficult to handle instruments and software because such complex purchases don't lend themselves to the side-by-side comparisons the way columns (and mortgages and airline tickets) do. So, for the moment, the experiment is with chromatography columns. If this project succeeds, then perhaps there is a chance that we will see it extended to more chemistry-related purchases.

In the June 1998 column about software validation and computerized systems, we recommended that you occasionally visit the US Food and Drug Administration (FDA) Web site for updates. Well, now would be a good time, because the FDA recently published another document related to the design and testing of the good laboratory practice software. A number of readers have written to say that they were not able to successfully navigate through the site to find the desired information, so we specify the Internet (or other) references here.

The best place to start is at the FDA!s Center for Devices and Radiological Health (www.gov/cdrh/ode/software.pdf). On 10 July 1998, the FDA published the "Guidance for FDA Reviewers and Industry: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." This document is especially helpful in providing a flowchart that describes when this document is relevant, as opposed to the FDA!s other guidelines, such as "General Principles of Software Validation."

Other resources are also available for software validation investigators. Perhaps the best starting point is "Software Development Activities, FDA Technical Report July 1987." This report can be obtained free of charge from the Fl), Ns Center for Drug Evaluation and Research (Office of Communication Management, FDA, CDER, HFD-210, 5600 Fishers Ln, Rockville, MD 20857). Available on the Web is a European paper, "The Application of the Principles of GLP to Computerised Systems" (Organization for Economic Cooperation and Development, Environmental Monograph No. 116, Paris, 1995; www.oecd.org/ehs/ehsmono/ene51434.pdf).

A draft guidance, released in June 1997, is entitled "Guidance for Industry: Computerized Systems Used in Clinical Trials" (www.fda.gov/cder/guidance/index.html). "Guidance for Industry: General Principles of Software Validation" (www.fda.gov/cdrh/comp/swareval.html) also was released in June 1997. Although developed for medical device software, this guidance says it is "based on generally recognized software validation principles and could therefore be applicable to any software." To become familiar with software validation technology, check the "Glossary of Computerized System and Software Development Terminology, August 1995" (www.fda.gov/ora/inspect_ref/igs/gloss.html).

TERRANCE A- ROONEY is a computer consultant in Santa Rosa, CA He worked for twenty one years in the analytical instruments industry, in the development and marketing of scientific software programs. He received his Ph.D. in physical analytical chemistry from the University of Iowa. His e-mail address is TRooney@Pacbell.net.