LIMSource News: What's New - March to April 2004

• Apotex Inc. Reports Rapid LIMS Upgrade
• LabVantage and SpectraLIMS Team Up to Address Laboratory Information Solutions for Growing French LIMS Market
• Natural Resources Canada Selects Sample Master LIMS to Enhance Productivity in Characterization Laboratory
• EarthSoft Announces the New EQuIS Data Processor
• Labtronics Releases Pipette Tracker Version 3.2
• LimsLinkCDS Interfaces Varian's Galaxie Chromatography Data System with any LIMS
• MiraiBio Launches DNASIS MAX Version 2.5 Sequence Analysis Software for Advanced Data Management and Analysis
• BioPoint Solutions Appoints Karen Moore Chief Science Officer
• Bruker Daltonics Appointed Seiichiro Tsurumaki as Assistant Vice President for Japan
• ARC Research Releases Report on Future of Warehouse Management Systems
• ARC Report States that the Expanding European Union has a Positive Impact on the ERP Market
• FDA Seeks Increased Funding for Fiscal 2005
• BIO Sets Agenda for 2004 to Encourage Innovations
• Applied Biosystems Announces Enhanced Version of Industry Leading SQL*LIMS Software
• PerkinElmer LabWorks Software Adds Features to Simplify Scheduling, Querying and Reporting
• Thermo Electron Releases SampleManager 2004
• LabVantage Announces SafeData for Scientific Data Management Operational Archiving
• AutoScribe Unveils Resource Planner
• Autoscribe Unveils New Matrix LIMS Software at Pittcon
• Thermo Electron Adds Web Capabilities to Nautilus LIMS
• Waters Corporation Introduces Digital Lab Notebook to Make Scientific Laboratories More Efficient
• MSC-LIMS Now Available for $500
• Green Mountain Logic, Inc. Launches LabPAS ~ Adaptive LIMS
• Bruker Introduces Novel Proteomics Research Information Management System (RIMS) for Drug Discovery and Target Validation
• PerkinElmer to Supply LIMS Software Solution For Hong Kong Water Supplies Department
• National Cancer Institute Core Genotyping Center Goes Live with LabVantage Sapphire Life Sciences LIMS
• EarthSoft Announces EQuIS Data Processor Purchases by EPA Region V and the Navy SouthDiv
• Transocean Inc. Signs Agreement with CARDIAC for IMATIS LIMS
• CARDIAC Delivers IMATIS LIMS to Statoil Tjeldbergodden
• Thermo Electron and Orbis Partnership Results in LIMS/CDS Integration Solution
• OPS Systems Acquires Telecation from RTS-Enabling Technology LLC
• Frost & Sullivan Recognizes LabVantage for Product Innovation in LIMS
• Frost & Sullivan Honors InnaPhase Corporation for Technological Innovation in LIMS
• ChemWare Receives 2004 Frost & Sullivan Award for Technology Quality Leadership
• Bio-Rad Further Extends Software Offerings to Academic Community
• Bio-Rad Launches Internet-Based Platform for Optimized Searching of Over 800,000 Spectra
• Chemical Inventory System Now Links to World’s Largest MSDS Database
• ChemSW's New Chemical Inventory System Module Links Unlimited Number of Documents
• Dionex Updates Chromeleon with Powerful New Features
• Labtronics Receives 2004 Frost & Sullivan Customer Service Innovation Award
• Labtronics BV Announces New Partnership in Germany, Austria, and Switzerland
• Labtronics Introduces New LimsLinkCDS Interface
• Agilent Technologies Combines Gene Expression, Proteomics and Reagents Businesses into New Life-Sciences Unit
• Agilent Technologies Introduces GC/MS Data System to Address Requirements of FDA 21 CFR Part 11
• Agilent Technologies Upgrades Software for Mass Spectrometry-Based Proteomics Research
• Varian Inc Launches Database Product for Secure Long-Term Storage of Chromatography Data
• Varian Introduces High-Throughput Autosampler for Automated Sample Introduction
• LIMS Expert Michael Tyszkiewicz Joins Innaphase Corporation
• New GE Fanuc Product Helps to Achieve 21 CFR Part 11, GMP Compliance
• Applied Biosystems, MDS Inc., and Waters Technologies Corporation Resolve Outstanding Litigation
• Bioworld Releases Biotechnology State of the Industry Report 2004
• FDA Revises Guidance on Premarket Validation for New Technologies
• New FDA Initiatives to Facilitate Innovation and Collaboration in Drug Development
• FDA Takes Steps to Protect Consumers from Counterfeit Drug Threats: RFID Considered

Apotex Inc. Reports Rapid LIMS Upgrade

InnaPhase Corporation, a world-leading provider of enterprise LIMS solutions, has announced that Apotex Inc., the largest Canadian-owned pharmaceutical company, has successfully and swiftly implemented and validated its Watson LIMS v. 7.0. "The installation and implementation time must have set a new benchmark," said Dr. Jeremy Desai, Sr. Vice President, Research & Development, for Apotex. "The Apotex team with InnaPhase's support and guidance produced a seamless implementation of the software with virtually no adverse impact on lab productivity." Watson is a built-for-purpose Laboratory Information Management System specifically designed to support DMPK/Bioanalytical studies in drug development. The system was developed by InnaPhase in conjunction with major pharmaceutical companies to accelerate bioanalysis and sample management in drug development. Apotex has been using Watson LIMS in its bioanalytical laboratories since 2002 at the company's research facilities in Toronto, Ontario, Canada. Apotex employs over 6,000 people in research, development, manufacturing and distribution facilities worldwide. Apotex produces more than 230 generic pharmaceuticals in approximately 4,000 dosages and formats which, in Canada, are used to fill over 55 million prescriptions a year -- the largest amount of any pharmaceutical company in Canada. InnaPhase Corporation provides 18 of the world's top 20 pharmaceutical organizations with its products and services. In addition to the EP Series, InnaPhase markets the 21 CFR Part 11 compliant Pharma LIMS Suite, a series of purpose-built LIMS applications which includes: Newton LIMS for batch release, quality control, formulation, stability and analytical development; Watson LIMS for pre-clinical and clinical bioanalysis; and Galileo LIMS for In Vitro testing. For details, visit http://www.innaphase.com.

LabVantage and SpectraLIMS Team Up to Address Laboratory Information Solutions for Growing French LIMS Market

LabVantage Solutions, Inc., a leading provider of Life Sciences LIMS and Enterprise LIMS solutions, and SpectraLIMS S.A., a leading French laboratory information solution provider, have announced that the two
organizations have signed a distribution agreement to jointly market and support the entire LabVantage Sapphire laboratory product line for the fast growing French and French-speaking European market. SpectraLIMS will provide the Sapphire information management solution to research institutes, service laboratories, and chemical, bio-technical, food, pharmaceutical, genomics, and proteomics labs. SpectraLIMS has become a preferred local French partner in quality management and research informatics initiatives because of its experienced project leaders, skilled technical support, and validation services. SpectraLIMS is certified ISO 9001 Version 2000, and has expertise in 21 CFR Part 11, GLP, BPF, COFRAC, FDA and GAMP requirements. For details, visit
http://www.spectralims.com or http://www.labvantage.com.

Natural Resources Canada Selects Sample Master LIMS to Enhance Productivity in Characterization Laboratory

Accelerated Technology Laboratories, Inc. has announced that the Characterization Laboratory/CANMET Energy Technology Centre-Ottawa (CETC-O) has selected ATL's Sample Master LIMS. CETC-O provides standard chemical analysis (ISO and ASTM) and R&D service to CETC-O’s in-house energy R&D programs, other government departments and private industry. The Characterization Laboratory was searching for a LIMS that would allow for a high degree of flexibility and user configuration in terms of PC screen interfaces (input) and reports (outputs). The laboratory is currently using its own terminology for individual samples, groups (or batches) of samples, sample labeling, individual and groups of analytical test codes. The laboratory staff is accustomed to this terminology and desired a new LIMS that would be configurable, to allow the continuing use of the same terminology. They selected Sample Master LIMS, which will allow the Characterization Laboratory to use its own terminology, thus optimizing training, easing the learning curve and decreasing implementation costs.
The Characterization Laboratory analyzes and tests samples for most projects involving bench and pilot-scale research established by CETC's technology programs. The Laboratory has active programs to develop novel analytical procedures and improve nationally and internationally standardized test methods. The Laboratory characterizes gaseous, liquid and solid products including by-products derived from the processing of coal, oil and biomass fuels. Its capabilities include a broad range of spectrometric, chromatographic and classical analytical techniques, the use of which is supported by a specially designed quality assurance program. For details, visit http://www.atlab.com.

EarthSoft Announces the New EQuIS Data Processor

EarthSoft has announced the EQuIS Data Processor (EDP) which improves on the critical data checking capabilities of its predecessor, the Electronic Lab Data Checker, and adds new features and user interactivity that significantly enhance usability and data processing tasks. Written in Visual Basic .NET and using XML-based format definitions, the EQuIS Data Processor retains basic data integrity checks such as reference values, field length, data type, and parent records while adding an optional interactive user interface that enables data corrections with immediate error status feedback, selection of valid values from drop down lists for standard data types, and custom data handlers to perform conditional checking (i.e. if field 1 is “A” then field 2 must be “B”), coordinate conversions, and other routine functions. The EQuIS Data Processor will also act as a preprocessor for several client-specific formats, such as the California State Water Resources Control Board’s Geotracker Laboratory Electronic Deliverable Format (EDF), ERPIMS, SEDD, and others. EarthSoft is aware of about twenty high volume formats, and there are hundreds of custom formats, presenting a huge problem for labs and organizations delivering data. The EQuIS Data Processor is provided to users under single, site, and corporate licensing. Current ELDC users with an up-to-date maintenance agreement will receive a credit towards their purchase of the EQuIS Data Processor. For details, visit http://www.earthsoft.com.

Labtronics Releases Pipette Tracker Version 3.2

Labtronics Inc. has released Pipette Tracker version 3.2, a pipette calibration and maintenance software that integrates directly with any serial Balance and with environmental monitoring devices for Humidity, Temperature and Pressure compensation correction. With an Instrument Library of over 400 pre-configured balance interfaces and a Pipette Library of over 700 pipette models, setting up the Pipette Tracker software with any type of pipette and interfacing directly with any balance is easy. A wide array of new features and enhancements are available for pipette calibration procedures. For details, visit http://www.labtronics.com.

LimsLinkCDS Interfaces Varian's Galaxie Chromatography Data System with any LIMS

Labtronics Inc. and Varian, Inc. have announced a new LimsLinkCDS interface for the Varian Galaxie Chromatography Data System (CDS), which provides Galaxie users with a direct and transparent connection with any LIMS. With the new interface, users can easily transfer information between the Galaxie CDS and the LIMS system used by their organization. LimsLinkCDS adds new menu items to the Galaxie data system that allow the user to access the LIMS without having to leave the CDS and authorized CDS users have access to the menu items without having to logon separately to use the LIMS interface. Configuration of the LimsLinkCDS - Galaxie interface is quick and easy using drop-down menus and check-boxes that use Galaxie terminology. LimsLinkCDS uses methods to store configurations allowing each analyst or group of analysts to use different pre-configured methods. LIMS worklists can be selected from directly within Galaxie. The analyst can view and edit the worklist to ensure it is complete and accurate before it is automatically expanded to include standards, check samples and replicates. LimsLinkCDS includes macros that can be used to automatically create a sequence name, RunName (prefix) and Run ID (suffix). The completed sequence is automatically stored in the directory specified by the Galaxie Project that the analyst has selected. Varian, Inc.'s Galaxie CDS is an intuitive, easy-to use-software platform that controls GC and LC instruments from a variety of vendors. For details, visit http://www.varianinc.com or http://www.labtronics.com.

MiraiBio Launches DNASIS MAX Version 2.5 Sequence Analysis Software for Advanced Data Management and Analysis

MiraiBio Inc. has introduced DNASIS MAX Version 2.5 Sequence Analysis Software, their next generation desktop bioinformatics tool offering advanced data management and analysis capabilities. DNASIS MAX is a robust sequence analysis software package that delivers industry standard functionality -- molecular biology tools, multiple consensus calling methods, and rapid BLAST searches -- as well as unique features that enhance common task performance and allow user-defined product customization. Notable functionality additions to DNASIS MAX Version 2.5 include customizable analyses and workflows using the product's unique open application programming interface (API) and software developer's kit (SDK) and direct interface with DNASIS Gene Index, the company's data query and knowledge mining service. Additional improved and enhanced product features include drag and drop analysis with instructional "wizard," improved tandem repeat, hairpin loop, tacking site search capabilities, and increased database functionality with novel text searching and editing options. For details, visit http://www.miraibio.com.

BioPoint Solutions Appoints Karen Moore Chief Science Officer

BioPoint Solutions, Inc., a provider of technology solutions and professional services for the biotechnology and pharmaceutical industries, has appointed Karen Moore, Ph.D., as Chief Science Officer. Dr. Moore will be responsible for overseeing the practical, science-based application of the company's flagship data management and workflow enforcement solution, DiscoverTrac², and related service offerings. Dr. Moore comes to BioPoint Solutions with more than 22 years experience in the life sciences and their practical application to medicine and the pharmaceutical industry. Most recently, Dr. Moore was a consultant for Etiologics Ltd., a UK-based biotechnology company, where she played a key role in the company's expansion to the United States. Prior to Etiologics, Dr Moore was Chief Science Officer and a co-founder of Hypnion, Inc., a biotechnology company dedicated to developing innovative therapies for sleep disorders. Prior to Hypnion, Dr. Moore served in a number of managerial level positions with Millennium Pharmaceuticals Inc. from its inception in 1993 until 2000. In her capacities as Director of Genetic Systems, Dr. Moore was responsible for the identification of numerous genes and targets in multiple therapeutic areas. Dr. Moore has authored over 60 publications, many of which have been published in the most eminent scientific journals such as Cell, Nature, Nature Genetics, Science and PNAS, and she is a named inventor on thirteen patents. While at both Hypnion and at Millennium, Dr. Moore was instrumental in the design of laboratory support IT solutions. This end user experience has contributed significantly to BioPoint Solutions' flagship product, DiscoverTrac. For details,visit http://www.biopointsolutions.com.

Bruker Daltonics Appointed Seiichiro Tsurumaki as Assistant Vice President for Japan

Bruker Daltonics Inc., an operating company of Bruker BioSciences Corporation, has announced that Mr. Seiichiro Tsurumaki has been appointed as its Assistant Vice President for Japan. Mr. Tsurumaki is responsible
for the management of the Company's marketing, sales, applications, customer support and research activities in Japan, and he will also join the Bruker Daltonics global management team. Mr. Tsurumaki has over 20 years of experience in sales and marketing of molecular biology research instrumentation in Japan, particularly concerning life-science mass spectrometry systems. In 1994, he became MALDI-TOF-MS and LC-MS Sales Manager for Nihon Perseptive Ltd. In 2000, he was appointed Sales and Marketing Director of Bruker Daltonics K.K. and established a new applications and customer center in Tokyo, from which he expanded both our direct sales and support system and also organized a nation-wide network of distributors in Japan. In 2002, Mr. Tsurumaki moved Bruker Daltonics K.K. to larger facilities in Yokohama and established an expanded applications and technical support center to further enhance customer support. For details, visit http://www.bruker-biosciences.com.

ARC Research Releases Report on Future of Warehouse Management Systems

The worldwide market for Warehouse Management Systems (WMS) experienced a rough year. Year over year revenues (2003 as compared to 2002) have shrunk. Total revenues dropped by 2.7 percent. According to Steve Banker, Service Director for Supply Chain Management at ARC Advisory Group, “Even more worrisome, because it is a key future predictor of growth, is that software revenues shrank by 6.9 percent. In other enterprise software markets we have examined, this has been a pre-cursor to several years of shrinking revenues for a market.” Steve Banker is co-author of ARC’s “Warehouse Management Systems Worldwide Outlook: Market Analysis and Forecast through 2008.” The report examiens the role that a new technology — passive tag Radio Frequency Identification (RFID) — could play. RFID is a hands free, remote sensing version of bar code technology. Many large companies are now mandating that their suppliers gear up to ship all cases and pallets with RFID tags, as well as to continue using bar codes. Wal-Mart was the first to mandate these changes; the US Department of Defense, Target, Albertsons, Metro, Tesco, and others are playing the role of fast follower and will soon announce their own RFID mandates. ARC predicts that in the short term, WMS suppliers can help suppliers to the retail behemoths become compliant through offering a new add-on WMS module that allows RFID tags to be placed on cases in the Warehouse. In the longer term, RFID capabilities are apt to become part of most suppliers’ base solution. Some manufacturers, not under immediate pressure to become compliant, may also choose to gain RFID capabilities through a WMS upgrade once suppliers have RFID enabled their base package.For details, visit http://www.arcweb.com/res/wms.

ARC Report States that the Expanding European Union has a Positive Impact on the ERP Market

The European Union, previously known as the European Community, is currently comprised of fifteen countries and some 370 million people with 11 official languages. They share the common institutions and policies that
have brought EMEA (Europe, Middle East, Africa) to be the leading geographical region implementing Enterprise Resource Planning (ERP) solutions. The worldwide market for ERP was $9.10 billion in 2003 and is forecasted to be over $12 billion in 2008, growing at a Compounded Annual Growth Rate (CAGR) of 5.7 percent over the next five years. The European Union, created after World War II to unite the nations of Europe, surpassed North America economically as the leading ERP region in 2002, and it continues that trend in 2003. The European Union is the largest economic entity in the world and it is now solidified even further by the single currency, the euro. ARC predicts that the European Union will become even a larger economic entity in 2004, and it is a key element of the growing ERP market. For details, visit http://www.arcweb.com/Newsmag/ent/erp040804.asp.

FDA Seeks Increased Funding for Fiscal 2005

The Bush administration is requesting funding of $1.49 billion for the FDA in fiscal 2005 and $350 million in drug industry user fees, according to FDA acting Commissioner Lester Crawford. Under the request, the agency would see a net budget authority increase of $108.8 million above fiscal 2004 approved appropriations, said Crawford, who laid out some of the agencyís budget priorities at a hearing before the Senate Agriculture, Rural Development and Related Services Appropriations Subcommittee. Crawford said in fiscal 2005, the agency plans to save $23.1 million through a 7.5 percent reduction in administrative staff. In addition, the FDA has not requested funding for its buildings and facilities budget, which will provide a savings of $7 million. The agency plans to carry over about $4.6 million from fiscal 2004 for these expenses. For details, visit http://www.fda.gov.

BIO Sets Agenda for 2004 to Encourage Innovations

The Biotechnology Industry Organization (BIO) has five major elements in its advocacy agenda for this year, according to the trade group's policy chief. Declaring 2003 to have been a banner year for the biotech industry because of robust investment and product development, BIO's Michael Werner said the trade association's challenge for this year was to sustain and enhance those accomplishments. The areas in which BIO will be working to ensure policies that encourage innovation include favorable tax treatment of net operating loss carry-forwards, passage of comprehensive energy legislation, project BioShield, U.S. Patent and Trademark Office fees and policymaking, and small business legislation. For details, visit http://www.fda.gov.

Applied Biosystems Announces Enhanced Version Of Industry Leading SQL*LIMS Software

Applied Biosystems has announced the latest version of its LIMS, SQL*LIMS version 5.0. The latest version includes an enhanced user interface delivered via a Web services application that provides a comprehensive, enterprise-accessible productivity solution for pharmaceutical manufacturing organizations. Additionally, the new SQL*LIMS software includes enhancements, such as instrument calibration, user qualification and reagent inventory tracking. SQL*LIMS software, installed in more than 1,000 laboratories worldwide, is a complete solution that automates sample tracking, laboratory processes and workflow, data access and storage, and regulatory compliance. The new, open platform Web services application was built using industry standard technology including the Oracle Application Server 10g, Database 9i and provides an extensible J2EE standards-based application. Additionally, Applied Biosystems expects to deliver a series of new product updates to SQL*LIMS software version 5.0 over the coming months. For details, visit http://www.appliedbiosystems.com.

PerkinElmer LabWorks Software Adds Features to Simplify Scheduling, Querying and Reporting

PerkinElmer, Inc., a leading provider of drug discovery, life science research and analytical solutions, has announced a range of new capabilities for its LABWORKS ES LIMS software that significantly improve scheduling, organizing and reporting critical laboratory data. Among the new capabilities is a Process Scheduler module used to schedule routine sampling and to monitor sample statuses throughout an organization. The Process Scheduler can flexibly define sampling groups based on time, frequency, sample locations, and type of analysis. A new Calendar View allows viewing of timed samples in a monthly or daily format and the color-coded system makes determining sample statuses easier. Other additions include a sophisticated new query function that makes it easy for users to work with data in both LABWORKS and outside databases. “The new capabilities added to LABWORKS help to automate some of the most important ongoing tasks in any lab,” said Stephen Delity, analytical solutions business manager for PerkinElmer Life and Analytical Sciences. “Saving time with sample-oriented work flow, more powerful analysis and reporting are top priorities for lab managers who need to maximize productivity and deliver secure, reliable results for better decision making.” For details, visit http://www.perkinelmer.com.

Thermo Electron Releases SampleManager 2004

Thermo Electron Corporation has released SampleManager 2004, a new generation of its flagship LIMS now offering powerful Web capabilities such as XML (eXtensible Markup Language) processing and an advanced Web interface for dynamic data submission. Providing the foundation for a laboratory automation solution, SampleManager 2004 is the ideal choice for organizations seeking a proven, dependable LIMS to serve as a corporate standard for consistent performance and predictable deployments across the global enterprise. SampleManager 2004 incorporates new Web services architecture that opens up core business logic to allow other applications and systems to access its functionality. The product utilizes XML to seamlessly integrate with enterprise resource planning systems, as well as chemical information databases and document management software. A new Web browser facilitates access by a wider user base, including business managers and process engineers located anywhere in the world. Samples and testing requirements can also be submitted via a web interface through a standard Internet security model.T he SampleManager solution also now offers new instrument integration capability that provides significant advantages to customers, including streamlined system administration and advanced functionality for the mapping and parsing of instrument output. As opposed to conventional PC-based instrument integration applications, SampleManager’s design utilizes scalable architecture based on Microsoft .NET technology. For details, visit http://www.thermo.com/informatics.

LabVantage Announces SafeData for Scientific Data Management Operational Archiving

LabVantage Solutions, Inc., a leading provider of Enterprise LIMS and Life Sciences LIMS solutions, has announced the introduction of SafeData. SafeData is a secure and accessible scientific data management solution for the live data phase of a project. SafeData automates the storage of operational data in its native format, and maintains easy access to files during the iterative analysis period, with versioning, to protect intellectual property. The targeted markets for SafeData are: pharmaceutical, biotechnology, research and science-based industries. LabVantage SafeData is a completely automated solution for collecting, processing, storing, and retrieving raw
analytical data. In environments where high levels of compliance to GLP/GMP regulations are required, LabVantage SafeData is a reliable, easy-to-administer, and secure method for archiving raw data within seconds of its creation or change. SafeData removes the reliance on individual scientists to move data from potentially unsafe instrument computers to secure locations - with no manual input required. SafeData breaks through the "my data" mentality that permeates through most research organizations. Developed with today's analytical systems in mind, SafeData takes into account the complex file structures of data acquisition software, and the need for flexible laboratory control of the transfer process, within a compliant framework. SafeData has two main modules. The first module, called Source Publisher, is for system administration. The second module, called Senior Editor, establishes overall approaches, rights, privileges, and standards to publish and access data for the scientific community. ASafeData Starter Kit with full product functionality is available for $5,000. For details, visit http://www.labvantage.com/safedata.

AutoScribe Unveils Resource Planner

To help laboratories raise productivity through better resource tracking and planning, a new software package called Resource Planner has been unveiled by Autoscribe. This highly intuitive system delivers rapid results and is easy to operate. Often in a laboratory, new tasks arrive at different times and, in some cases, resources are lost. This complex and time consuming process places a significant drain on resources and planning. To address this need, Resource Planner uses ‘what-if’ scenarios by recalculating work completion times, and adjusting the priority of tasks accordingly. Resource Planner looks at any new or outstanding laboratory task and suggests an optimal plan for completion based on workload priority, task completion times, and resource availability. Short term planning is achieved through automatic weekly scheduling and work sheet generation, whilst longer term planning is possible through due date checking and task completion time allocation. Resource Planner identifies expertise and instrument availability, and even the appropriate member of staff assigned to a specific task. Information is also presented in clear, highly intuitive graphs for quick and easy assessment. Built using the latest Microsoft.NET framework, Resource Planner has the look and feel of Matrix LIMS, Autoscribe’s primary laboratory management system. It uses Artificial Intelligence algorithms to generate plans for maximum performance and results in the workplace. For details, visit http://www.autoscribe.co.uk.

Autoscribe Unveils New Matrix LIMS Software at Pittcon

Leading software systems developer, Autoscribe unveiled three major new software solutions for the scientific laboratory, general business and industry training sectors on booth 654 of the Labinformatics section at Pittcon 2004. All of these products have been developed using the .NET framework. The first new solution was Matrix Version 5: a new updated version of Autoscribe’s LIMS that offers even greater flexibility and usability. Access is now possible via conventional Windows client or Internet connections, and interfaces are easy to produce using the powerful Matrix configuration tools developed by Autoscribe. For maximum convenience and minimum training time, the user screens for both web and client access are identical in appearance. Resource Planner is another new software solution that maximises the allocation of resources within a laboratory. Designed to save time and effort, it can operate as a standalone system or with a linked LIMS. Resource Planner makes use of advanced artificial intelligence and was developed in conjunction with the University of Reading, UK. Ideal for any company, Training Manager simplifies the organisation of training programmes for greater efficiency and productivity. This powerful new software tracks the training needs of all company individuals, whether related to job titles or specific tasks in a laboratory, and maintains records of all current and completed courses, as well as future training schedules. Other laboratory specific solutions making their debut include Magic, a powerful interface between Matrix LIMS and the Varian Galaxie chromatography data system; the new updated ‘Instrument Calibration and Maintenance’ software for total instrument management, ‘Sample Tracker’, and the highly functional ‘Stability Management’ system. For details, visit http://www.autoscribe.co.uk.

Thermo Electron Adds Web Capabilities to Nautilus LIMS

Thermo Electron Corporation has announced the availability of a new Web browser interface and powerful XML (eXtensible Markup Language) processing capabilities in the latest version of its Nautilus LIMS. These latest enhancements speed deployment, facilitate integration with other technologies and applications, and reduce operating costs. Nautilus LIMS sets new standards for configurability, functionality and efficient use of resources in R&D laboratory environments. This new version of Nautilus greatly simplifies access to data, allowing for more streamlined lab processes with users able to work more efficiently within the lab. Functionality can quickly and cost-effectively be extended to authorized scientists and researchers operating at other facilities, conducting related and collaborative projects outside the lab. Individuals can submit samples and access up-to-date sample data and reports via an intuitive Web interface. Nautilus security ensures users access only those sample results they are authorized to view. As users submit samples and view data remotely, lab personnel spend less time responding to requests for status updates and have better insight to upcoming workloads. In addition, the intuitive Web interface allows even the most casual users to generate HTML reports, which can be viewed from the browser. For details, visit http://visit www.thermo.com/informatics.

Waters Corporation Introduces Digital Lab Notebook to Make Scientific Laboratories More Efficient

Waters Corporation introduced its Waters eLab Notebook software at Pittcon 2004. The eLab Notebook software is for any scientist currently keeping paper notebooks to record scientific information. It is also for multi-national organizations and their IT professionals intent on protecting intellectual property, improving organizational efficiency, ensuring adherence to good lab notebook practices and cutting time-to-market by allowing scientists, no matter where they are, ready access to more of the work done by colleagues. Waters eLab Notebook Software electronically captures information – spectra, chemical structures, observations, experimental conditions, ideas, findings, images and drawings, tables, spreadsheets, even movies – just about anything that scientists enter into their present-day notebooks, regardless of the software application it originated in. Standard notebook templates can also be created to match a lab’s established workflows, making the transition from paper to digital documentation easier and allowing organizations to maintain rules of good notebook practice. Searching for information through the Waters eLab Notebook Software is easy. The software automatically extracts metadata descriptions of saved information. Scientists can perform contextual searches and locate specific chemical structures, substructures, reaction conditions, and so forth, months and years after the notebook entry. Of course, text searches can be done as well. The product is built with an Object Linking and Embedding (OLE) technology framework, enabling the eLab Notebook Software to seamlessly share information among a variety of programs used by scientists. Once captured by the notebook, information is centrally archived in electronic form, and is available to anyone with authorized access. For details, visit http://www.waters.com.

MSC-LIMS Now Available for $500

Mountain States Consulting, LLC, has announced a significant reduction in the cost of its annual subscription license to $500 per user per year for the complete MSC-LIMS system. The new subscription price heralds the June 2004 release of MSC-LIMS version 3.0, an Access 2002-based version. Annual subscriptions are available for both standalone and multi-user configurations, and technical support and version updates are included throughout the subscription period. The annual subscription provides a complete non-source code version of all MSC-LIMS software including MSC-LIMS Archiving and MSC-LIMS Messaging. MSC-LIMS’ integrated Excel interface extends the system’s capabilities with custom reporting, data importing, and instrument interfacing without the need for customization. MSC-LIMS is a complete laboratory information management system (LIMS) designed for small to mid-sized labs, and successfully implemented for nearly a decade in environmental, food testing, and petrochemical laboratories. The new annual subscription appeals to labs with requirements satisfied by MSC-LIMS “out of the box,” allowing even the smallest lab to enjoy the benefits of a complete LIMS. A detailed price list, all product literature, and downloadable MSC-LIMS demo, MSC-LIMS Report Viewer, example reports, and Excel report examples, are available at http://www.msc-lims.com.

Green Mountain Logic, Inc. Launches LabPAS ~ Adaptive LIMS

Green Mountain Logic’s highly adaptive LIMS solution, LabPAS, made its public debut at the recent Pittcon 2004 conference. LabPAS incorporates advanced Process Automation functionality to map directly to the operations of specialized labs with complex workflows. LabPAS has a powerful workflow engine and configurable task, test, and result entry tools to conform to laboratory’s operating procedures and business rules. LabPAS has a browser-based user interface that offers enterprise-wide sample tracking, worklists, ordering, inventory, lot management, lab metrics, donor management, internal messaging, instrument interfacing and many more features. LabPAS also employs Adaptive Hook Technology to allow labs to customize the application for their specific needs while preserving forward compatibility and supportability. The system is FDA CFR 21 Part 11 compliant and is backed by a comprehensive warranty. Green Mountain Logic also provides the full range of professional services to ensure a successful implementation and adaptation to laboratory environments. Green Mountain Logic is a software products and services company specializing in solutions for high-compliance laboratories, hospitals, and medical device companies. For details, visit http://www.labpas.com.

Bruker Introduces Novel Proteomics Research Information Management System (RIMS) for Drug Discovery and Target Validation

At the 2004 Pittsburgh Conference in Chicago, Bruker BioSciences Corporation announced Proteomics RIMS, a new proteomics research software environment based on modern web and database technologies, that features a novel approach to integrate different proteomic methods for transforming data into knowledge. Proteomics RIMS is a bioinformatics solution that combines and integrates the data, information and knowledge generated in the proteomics research workflow from complementary mass spectrometry and x-ray crystallography technologies. In addition, Proteomics RIMS provides access to proteomic interaction and structural data provided by SPR-MS (in collaboration with Biacore) and by NMR (in collaboration with Bruker BioSpin). Proteomics RIMS combines Bruker BioSciences' ProteinScape software for managing the workflow in expression proteomics and Bruker BioSpin's SampleTrack LIMS applications to form the backbone of a data warehousing technology providing an environment of data, programs and links to databases to support efficient data analysis, research decision-making and knowledge generation in proteomics. Consolidating information across different platforms is a key to gaining in-depth understanding and to finding relationships and information in experimental data. The information management part of Proteomics RIMS covers instrument control, data acquisition, and the retrieval of data for documentation and archiving. Proteomics RIMS enables the integration of all these functions and controls them from one single user-interface. It informs about the status of the laboratory measurements and manages the application flow and activities within the laboratory. In addition, Proteomics RIMS also manages and integrates advanced data analysis and database search results.For details, visit http://www.bruker-biosciences.com.

PerkinElmer to Supply LIMS Software Solution For Hong Kong Water Supplies Department

PerkinElmer, Inc., a leading provider of drug discovery, life science research and analytical solutions, has announced that it will provide its LABWORKS Enhanced Security (ES) LIMS software for managing critical laboratory data for the government of Hong Kong Special Administrative Region. Valued at about US$1.2 million, covering both system implementation and maintenance services, the contract deploys the software to more than ten sites operated by the Hong Kong Water Supplies Department (WSD). Water quality in a major metropolitan area such as Hong Kong requires a very large monitoring infrastructure that measures hundreds of samples daily. The PerkinElmer LABWORKS ES LIMS software will improve laboratory efficiency and productivity while ensuring data integrity by scheduling sample test requests, collecting information from the various analytical instruments in the labs and controlling the flow of data so that activity in the lab is carefully documented and the information obtained properly recorded and disseminated to authorized users for decision making. The LABWORKS ES LIMS software to be installed in Hong Kong is an Enhanced Security (ES) version that gives users the ability to develop more efficient processes and meet regulatory requirements that rigorously identify users, login and track samples, and audit workflow. In addition, LABWORKS ES LIMS makes it easy to gather information about groups of samples to reveal trends or flag results outside specifications for quality and that require rapid response to assure water purity. For details, visit http://www.perkinelmer.com.

National Cancer Institute Core Genotyping Center Goes Live with LabVantage Sapphire Life Sciences LIMS

LabVantage Solutions, Inc., has announced that the National Cancer Institute (NCI), the federal government's principal agency for cancer research and a component of the National Institutes of Health, is now live with LabVantage's Sapphire Life Sciences LIMS solution. The Core Genotyping facility of the Intramural Program of the National Cancer Institute performs high-throughput genotyping and sequencing to support genetic analysis for a broad range of projects for NCI's Division of Cancer Epidemoilogy and Genetics (DCEG) and Center for Cancer Research (CCR). The Core Genotyping facility is currently performing high throughput gentic analysis of over 25 different case-control and cohort-based association studies, with as many as 75,000 separate samples expected to be analysed. NCI's Core Genotyping facility is using LabVantage Sapphrie software to perform the high throughput genotyping analysis. For details, visit http://www.labvantage.com.

EarthSoft Announces EQuIS Data Processor Purchases by EPA Region V and the Navy SouthDiv

EarthSoft has announced several purchases of the new EQuIS Data Processor (EDP) and the Electronic Lab Data Checker (ELDC). The Navy SouthDiv and EPA Region V have purchased re-distribution licenses of the EDP data-checking tool for use by their labs and consultants preparing data submittals. Over 100 labs in the US now have either the EDP or ELDC, making EQuIS EDDs and EQuIS EDD checking tools one of the most widely used in the industry. Other EQuIS data quality tools, including the Completeness Checker, Data Qualification Module, and EDP Online, are used by many labs and consultants to ensure data quality and improve analytical correctness and completeness. The new EDP is a built on the Microsoft .NET framework and utilizes modern W3C standards (including XML and XML Schema) for defining and checking EDDs. EarthSoft develops and markets software for the management of environmental data. For details, visit http://www.earthsoft.com.

Transocean Inc. Signs Agreement with CARDIAC for IMATIS LIMS

Transocean Inc., one of the world's largest offshore drilling companies, and CARDIAC have signed a contract for delivery of CARDIAC’s IMATIS LIMS as a”Data Gathering System (DGS)” at the rig Polar Pioneer. The solution includes delivery of IMATIS PIMS (process information management system), hardware from National Instruments (Fieldpoint I/O system), design of human-machine interfaces and electric installation. In connection with Transocean’s needs for upgrading the Data Gathering System at Polar Pioneer, a solution from CARDIAC was chosen. The new system shall be installed in existing infrastructure and shall be connected to existing sensor signals. The new I/O-system delivered by CARDIAC is Fieldpoint from National Instruments. The system utilizes the OPC standard for communication with CARDIAC’s IMATIS PIMS that acquires, analyzes, stores and all data in real time as well as historic. Included in the delivery is a trend-system, an integrated alarm and event system and human-machine-interfaces for the operators. The system shall primarily be used in various control rooms at the rig, however it is scalable and can through its web-based architecture also be utilized in all other parts of the Transocean network. For the electrical installation Profitek Industri & Offshore AS, Stavanger is CARDIAC sub-contractor. For details, visit http://www.cardiac.no.

CARDIAC Delivers IMATIS LIMS to Statoil Tjeldbergodden

CARDIAC has signed a contract with Statoil Tjeldbergodden for delivery of IMATIS LIMS to the production plant. Four plants currently make up the Tjeldbergodden industrial complex in the mid-Norwegian county of Møre and Romsdal. These are a gas receiving station, an air separation plant, a methanol plant and a gas liquefaction facility. IMATIS LIMS gives Statoil a high quality and audit system for all analyses from the production and laboratory. With IMATIS LIMS, Statoil control the production quality in real time, receive results direct from instruments, do statistic analysing and trace all events and transactions in the system. For details, visit http://www.cardiac.no.

Thermo Electron and Orbis Partnership Results in LIMS/CDS Integration Solution

Thermo Electron Corporation has announced the availability of a new LIMS/CDS integration solution resulting from its partnership with leading systems integrator Orbis Information Systems. Thermo now offers SampleManager-Millennium, a new interface for its flagship SampleManager LIMS and the Millennium32 or Empower Chromatography Data Systems (CDS) from Waters Corporation. The solution facilitates seamless electronic data flow and full integration between the two products, supporting compliance in regulated environments. Orbis is a Strategic Implementation Partner of Thermo and a charter partner in the Waters software partnership program. These partnerships, combined with direct product design input from pharmaceutical industry customers, have allowed a collaborative approach to the development of SampleManager-Millennium. As a result Thermo is able to provide powerful bi-directional integration with SampleManager for organizations that have standardized on Millennium32 CDS. The Thermo/Orbis partnership has resulted in other successful niche integration products, including SampleManager-IP21, the standard interface between SampleManager and the InfoPlus.21 PIMS (Process Information Management System) from AspenTech Technologies, Inc. For details, visit http://visit www.thermo.com/informatics.

OPS Systems Acquires Telecation from RTS-Enabling Technology LLC

OPS Systems has announced the acquisition of the Telecation lporodiuct line, including the Aspen LIMS software, from RTS Enabling Technology LLC. OPS Systems provides strategic data management software and preventative maintenance software solutiosn for water and wasterwater plant operations. For details, visit http://www.opssys.com or http://www.telecation.com.

Frost & Sullivan Recognizes LabVantage for Product Innovation in LIMS

In a recent analysis of the world LIMS market, Frost & Sullivan highlighted the tremendous advances pioneered by LabVantage Solutions, Inc. in developing LIMS solutions that minimize deployment costs and maximize investment returns. LabVantage’s Industry Solution Accelerators – first released for proteomics research – provide out-of-the-box functionality for specific industry needs. In the past, LIMS implementations required significant customization, which made deployment a time-intensive and costly exercise. This negatively affected return on investment and, in a tight economy, limited the adoption or replacement of LIMS. A product that reduced implementation costs while maintaining functionality was needed to stimulate demand outside the traditional customer base. “LabVantage has demonstrated a customer savvy that has enabled it to increase its market share, most notably in the proteomics industry. More than 50 percent of proteomics LIMS installations are performed using Sapphire LIMS,” says Nate Cosper, industry manager for Frost & Sullivan. For its keen understanding of customer needs and demonstrated excellence in new products and technologies within the industry, LabVantage is the recipient of the 2004 Frost & Sullivan Award for Product Innovation. The award recognizes innovation through the launch of broad line of emerging products and technologies. The strategy of developing Industry Accelerators is an approach that underscores LabVantage's commitment to delivering innovative products that address key customer needs. LabVantage develops LIMS solutions that provide clear value to the customers by forming partnerships with best-in-breed vendors and by designing specific industry applications. For instance, the company collaborated with major healthcare vendors to ensure that the Proteomics Accelerator maximizes productivity in the research laboratory. For details, visit http://www.frost.com or http://www.labvantage.com.

Frost & Sullivan Honors InnaPhase Corporation for Technological Innovation in LIMS

In a recent analysis of the World LIMS market, Frost & Sullivan named InnaPhase Corporation recipient of its 2004 Award for Technology Innovation for developing purpose-built, ready-to-deploy LIMS solutions that are designed to address the specific needs of pharmaceutical laboratories. In its study, Frost & Sullivan highlighted InnaPhase’s focus on providing cost-effective solutions, to the pharmaceutical industry in particular, by developing a series of purpose-built applications for its Pharma LIMS Suite. Within the LIMS industry, many vendors promote generic LIMS that were not designed with industry challenges in mind. These systems require that a compromise be reached between existing laboratory protocols and the capabilities of the LIMS product. Often, this process involves substantial customization of the systems, which increases the costs of the implementation. InnaPhase understands that formulations groups and long-term stability laboratories have standard practices that are substantially different from those of quality control laboratories. By developing a series of purpose-built applications as part of its Pharma LIMS Suite, InnaPhase has ensured that each laboratory within a pharmaceutical organization has a LIMS application that is specifically designed for their business practices. For details, visit http://www.innaphase.com.

ChemWare Receives 2004 Frost & Sullivan Award for Technology Quality Leadership

In a recent analysis of the World LIMS Markets, Frost & Sullivan recognized ChemWare, Inc.’s focus on devoting significant resources to develop a product based on user-selectable business rule parameters and for significantly reducing the risks, resources, and time associated with LIMS deployment. When implementations go awry, the LIMS project becomes an end in itself, forcing the management to rely even more on the IT staff for control over business practices. In many cases, the need for extra IT support can substantially decrease the original benefits of the LIMS project. Embracing the client’s need for business control, ChemWare focused its design strategy and development efforts on producing an off-the-shelf LIMS solution that shifts the laboratory reins from the IT department back to the business unit leader. The company accomplished this by creating an open architecture LIMS platform, which promotes configuration instead of customization. In fact, not a single HORIZON user has had to change source code in order to meet industry- or lab-specific needs. The HORIZON LIMS from ChemWare offers a complete audit trail, 21 CFR Part 11 and CROMERR-compliant record keeping. In addition, it provides state-of-the-art data management and reporting tools made possible through its OEM partnerships with NuGenesis Technologies Corporation and Actuate Corporation. For details, visit http://www.chemware.com.

Bio-Rad Further Extends Software Offerings to Academic Community

Bio-Rad Laboratories, Inc. has announced the introduction of KnowItAll Informatics System version 4.0, which will give academic chemistry software users "on-demand" access to additional software options. In September 2003, Bio-Rad released the KnowItAll Academic Edition to promote learning and research initiatives in academia. Since then, users from thousands of universities around the world have downloaded the KnowItAll Academic Edition via http://www.knowitall.com/academic. This product offers completely free and fully integrated chemical structure drawing, publishing, and spectral analysis software applications. Because of the success of the fall academic program and the increasing demand for other solutions offered by Bio-Rad, the company is initiating "on-demand" access to expand its offerings to the academic community. With "on-demand" access, Academic Edition users can automatically activate additional software options within KnowItAll, such as the IUPAC NameIt for IUPAC naming and Model It HNMR for advanced proton NMR spectrum prediction. All transactions take place via a secure Internet connection, and there is no need to install additional software to access the new or upgraded applications. KnowItAll users simply choose the software and database options they wish to purchase, and the new functionality is automatically activated. For details, visit http://www.informatics.bio-rad.com.

Bio-Rad Launches Internet-Based Platform for Optimized Searching of Over 800,000 Spectra

Bio-Rad Laboratories, Inc. has introduced a new Internet-based client-sever platform designed for high-speed searching of more than 800,000 spectra. With this new platform, users now have the option to access award-winning KnowItAll spectral databases via the internet rather than installing the data on their own computers. This new on-line capability will enable scientists to free up local hard drive space and conduct structure, substructure, chemical property, spectral, and peak databases searches at dramatically higher speeds than previously possible. Internet access to KnowItAll databases will also decrease IT maintenance and updating burdens. Installation procedures using an Internet-based platform for databases only require installation of KnowItAll client software. Internet-based searching saves both the end user and the IT department time, local server installation costs and maintenance, and also enables Bio-Rad to offer more cost-effective site licensing options. For details, visit http://www.informatics.bio-rad.com.

Chemical Inventory System Now Links to World’s Largest MSDS Database

ChemSW, Inc. demonstrated its link to ChemWatch at Pittcon 2004, enabling users of the CIS Chemical Inventory System CISPro to subscribe and link to the largest database of independently researched MSDS (materials safety data sheet) documents. Available in multiple languages, the ChemWatch database provides the most detailed information available on chemical hazards identification, first aid, first response, personal protective equipment, physical properties, toxicology and regulations. Data is available for 40,000 pure substances and 75,000 mixtures. ChemSW’s CISPro was developed specifically for the management and tracking of laboratory chemicals in regulated environments. For details, visit http://www.chemsw.com.

ChemSW's New Chemical Inventory System Module Links Unlimited Number of Documents

ChemSW, Inc. demonstrated its new Internal Document Storage Module for the CIS Chemical Inventory System CISPro at Pittcon 2004. This feature saves time and eliminates paper trail steps by linking all documents that relate to a particular chemical container in the inventory tracking system. Critical documents include Certificates of Analysis and MSDS, as well as any testing results. The new software module is available for any CISPro Chemical Inventory System, from desktop to enterprise and web-enabled versions. ChemSW’s CISPro was developed specifically for the management and tracking of laboratory chemicals in regulated environments. For details, visit http://www.chemsw.com.

Dionex Updates Chromeleon with Powerful New Features

Dionex has introduced Release 6.6 of the Chromeleon Chromatography Management System software. The new release expands instrument control, adds new data analysis capabilities, and enhances compliance-related features. Release 6.6 adds over 30 new LC and GC instrument drivers, bringing Chromeleon's automation portfolio to over 200 chromatographic instruments from more than 25 manufacturers. New instrument control capabilities include sequence scheduling, graphical editing of programs, and fraction collection and reinjection with the new APS-2000 Autopurification System. A new Simultaneous Injection feature allows a sample to be analyzed on two chromatography systems that share one autosampler. New Standard Addition methods quantitate analytes at ultratrace levels and in challenging matrices. Optional inversion of variables before curve fitting improves quantitation for certain applications, and new apex logic ensures consistent assignment of retention times, even for poorly resolved shoulder peaks. Peak retention windows help ensure correct peak identification, and a new "mirrored" display option for chromatogram comparison simplifies analysis. Automatic repeating of report blocks generates a report table for each sample or peak, without requiring changes to the report form when sample sets or peak sets change. Changes made to report forms are now tracked in audit trails, and new search functions speed and simplify audit trails. Administrators can now specify who can stop a batch, and can prohibit printing of unsaved reports. Chromeleon's unique Network Failure Protection now offers fully automated data resynchronization. Enhanced encryption of database transactions further strengthens security. For details, visit http:/www.dionex.com.

Labtronics Receives 2004 Frost & Sullivan Customer Service Innovation Award

Labtronics Inc. has announced that they are the 2004 recipient of the Frost & Sullivan Customer Service Innovation Award. To choose the award recipient, the analyst team tracks all customer service innovation and new system implementation in the industry. This is accomplished through interviews with market participants, extensive secondary research, and customer surveys. Also considered is whether industry adoption of similar systems followed the previous innovation. Competitors are then compared and ranked for relative position. The company chosen to receive the award is determined to hold the number one industry ranking. In selecting Labtronics as the award recipient, Frost & Sullivan noted that Labtronics has a history of creating products that enable information technology to deliver the promise of increased operational efficiency. For details, visit http://www.labtronics.com.

Labtronics BV Announces New Partnership in Germany, Austria, and Switzerland

Labtronics BV has announced the appointment of Vialis GmbH as their distributor for LimsLink and Nexxis software in Germany, Austria, and Switzerland. Vialis will provide full LimsLink and Nexxis implementation services to their clients. As part of Vialis' "Paperless Laboratory Solutions", LimsLink will provide secure and accurate transfer of data from any analytical equipment directly to any LIMS. Nexxis will provide both RS232 interfacing and real time SOP control and automation. For details, visit http://www.vialis.ch or http://www.labtronics.com.

Labtronics Introduces New LimsLinkCDS Interface

Labtronics Inc has introduced a new LimsLinkCDS interface that simplifies the creation of a secure, bi-directional
connection between Chromeleon Chromatography Management Systems and any LIMS. Configuration of the LimsLinkCDS - Chromeleon interface is quick and easy using drop-down menus and check-boxes that use Chromeleon terminology. Each analyst or group of analysts can setup and store their own interfacing configurations. The fileless Chromeleon/ LimsLinkCDS interface communicates directly with Chromeleon
and the LIMS without creating additional files outside of either application, a critical consideration with respect to 21 CFR Part 11 compliance. For details, visit http://www.labtronics.com.

Agilent Technologies Combines Gene Expression, Proteomics and Reagents Businesses into New Life-Sciences Unit

Agilent Technologies Inc has announced the formation of the Integrated Biology Solutions (IBS) unit within its Life Sciences and Chemical Analysis business group. This new unit consolidates management of Agilent's growing gene expression, proteomics and reagents businesses under the leadership of Fran DiNuzzo. DiNuzzo, who joined HP/Agilent in 1981, has held several senior R&D, manufacturing and marketing management positions during the past 20 years, including vice president of the Chemical Analysis Solutions unit and, most recently, vice president of the Bio-Reagents, Consumables and Services business. "The new structure will provide a single interface through which Agilent can better serve its customers in basic research, drug discovery and early-stage drug development," said DiNuzzo, vice president and general manager of IBS. "It will enable the rapid development of products that bridge multiple disciplines, thereby facilitating a more integrative study of biological organisms often referred to as 'systems biology.' " Pharmaceutical, biotech and academic customers use a combination of technologies to research disease and potential new drugs. The data obtained during research -- whether from RNA, DNA or proteins -- is applicable to the broader study of biological systems such as molecular pathways and cellular metabolism. But it has traditionally been very difficult to integrate these diverse technologies and the data they produce. Agilent's new business unit pulls these technologies and markets under the same leadership with an eye toward the development of more comprehensive and integrated customer solutions. For details, visit http://www.agilent.com.

Agilent Technologies Introduces GC/MS Data System to Address Requirements of FDA 21 CFR Part 11

Agilent Technologies Inc. has introduced the Agilent MSD Security ChemStation, the first data system for gas chromatography/mass spectrometry (GC/MS) from Agilent that addresses all requirements of FDA 21 CFR Part 11 for a closed system. The new software facilitates the compliant use of GC/MS in pharmaceutical environments.
With the introduction of this new ChemStation software, Agilent has compliance solutions for all its major analytical platforms used in the pharmaceutical industry, including GC, GC/MS, liquid chromatography (LC), LC/MS, capillary electrophoresis (CE), CE/MS, and UV/Vis spectroscopy. The new MSD Security ChemStation provides productivity and compliance support features to address the data security, integrity and traceability requirements of FDA 21 CFR Part 11. The software offers result versioning and version management; user-independent, automatic audit trails; and electronic signing capabilities for electronic records. Access to the application is protected by mandatory logon with a user identification code and password. Electronic records generated by the application are always stored with all related raw, meta and result data. For details, visit http://www.agilent.com.

Agilent Technologies Upgrades Software for Mass Spectrometry-Based Proteomics Research

Agilent Technologies Inc. has introduced a major upgrade to its Spectrum Mill MS proteomics workbench. The new version improves its performance and ease of use in a broad range of proteomics applications. The Spectrum Mill workbench is a suite of software tools for identifying proteins from mass spectrometry (MS) data, determining protein expression levels and correlating data from multiple samples or experiments. It includes advanced data extraction and searching capabilities that greatly speed protein identification and reduce the
number of false positive matches. The software can process data from both Agilent and non-Agilent mass spectrometers. The new version of the Spectrum Mill MS proteomics workbench supports the Microsoft Windows Server 2003 and Windows 2000 Server operating systems. For details, visit http://www.agilent.com.

Varian Inc Launches Database Product for Secure Long-Term Storage of Chromatography Data

Varian, Inc. has introduced a new option for its Galaxie Chromatography Data System (CDS). With the Galaxie DataBase, customers have the option to collect and store chromatographic data in a flat file format, as an object within a relational database, or both. It also includes powerful data archiving features for long-term records storage. It is fully integrated with the Galaxie CDS to offer customers a single efficient tool for handling multiple chromatographic data needs. The software contains a suite of features that allow customers to comply with FDA 21 CFR Part 11 regulations, meeting the FDA requirements that pharmaceutical laboratories store data and associated information for 10 or more years. The Galaxie DataBase offers a host of benefits for pharmaceutical and other regulated laboratory customers, such as: a relational database for chromatographic record storage, easy retrieval through multi-criteria queries, archiving functions, and integration with either an Oracle or a Microsoft SQL Server for use in any IT environment. For details, visit http://www.varianinc.com.

Varian Introduces High-Throughput Autosampler for Automated Sample Introduction

Varian, Inc. has unveiled a new autosampler – the SPS3 Sample Preparation System – that demonstrates unparalleled speed and sampling throughput with Varian’s range of AA, ICP-OES, ICP-MS, and UV-Vis instruments. For modern analytical laboratories, sampling throughput and automation are the keys to laboratory success. For both large and small operations, faster analysis translates into revenue growth, lower running costs, reduced gas consumption, and savings in labor expenses. The SPS3 base system offers multiple productivity enhancing features and can be easily re-configured by busy laboratories to further improve processing speed. In addition to its impressive stand-alone sampling capabilities, the SPS3 can be customized with Varian, Inc’s high performance diluter to make it an ideal automated tool for sample preparation. For details, visit http://www.varianinc.com.

LIMS Expert Michael Tyszkiewicz Joins Innaphase Corporation

InnaPhase Corporation, a world-leading provider of enterprise LIMS solutions, has announced the addition of Michael Tyszkiewicz, formerly of Applied Biosystems, as director of product development. Mr. Tyszkiewicz’s primary focus at InnaPhase will be to guide product development strategies in preparation for a new product release to be previewed at the 2004 Pittsburgh Conference. With over 30 years experience in laboratories, he has focused for 20 years on LIMS solutions, including implementation, system management, sales and product development. Previously, Mr. Tyszkiewicz managed professional services at Applied Biosystems, developing methodology and project management for the delivery of successfully validated LIMS solutions in the pharmaceutical industry. He studied chemistry at Rutgers University and information technology at Louisiana State University. For details, visit http://www.innaphase.com.

New GE Fanuc Product Helps to Achieve 21 CFR Part 11, GMP Compliance

GE Fanuc's new open architecture Information Portal Solution provides a framework for manufacturers seeking to achieve 21 CFR Part 11 and GmP compliance, meeting government regulations specifically aimed at production record keeping. This software toolset is designed to help life sciences companies capture, analyze and act on plant production data to improve profitability, efficiency and compliance while performing product genealogy reporting for traceability. According to the company, this suite of plant intelligence software applications provides web-based batch reporting, data collection and batch record analysis, captures and maintains proof of compliance, and facilitates real-time quality analysis. This helps users to capture critical production information that can be securely shared while simultaneously recording any change information in a compliant repository. For details, visit http://www.gefanuc.com.

Applied Biosystems, MDS Inc., and Waters Technologies Corporation Resolve Outstanding Litigation

Applied Biosystems Group and MDS Inc., through their Applied Biosystems/MDS Sciex partnership, and Waters Technologies Corporation have entered into a settlement agreement resolving outstanding litigation between them. The settlement provides for the resolution of patent infringement claims made by certain of the parties against the other in the United States and of international cases brought by Applied Biosystems and MDS against Waters Technologies in the United Kingdom, Canada and Japan. In connection with the settlement, Applied Biosystems and MDS and Waters Technologies have entered into royalty paying license agreements cross licensing the use of the technology described in the parties’ respective patents at issue. In addition, Waters Technologies Corporation has agreed to make a one-time payment to Applied Biosystems and MDS of $18.1 million. For details, visit http://www.appliedbiosystems.com.

Bioworld Releases Biotechnology State of the Industry Report 2004

Year-end figures show that money flowed more freely into biotech during 2003 than it has in recent years, as the industry raised about $16.5 billion, a sizable up-tick over the $10.25 billion brought in a year earlier. That 2002 figure, along with $14.7 billion raised in 2001, were a far cry from the approx. $38 billion raised in 2000. As the financing markets swung back, the 2003 figure ranks second in terms of total funds ever raised in the industry. These findings and more are revealed in the new edition of the BIOWORLD BIOTECHNOLOGY STATE OF THE INDUSTRY REPORT 2004. The 441-page report contains hard data from every facet of the industry: new product development, biotech stock performance, corporate deals and scientific breakthroughs. For details, visit:
http://mailiwant.com/links.jsp?linkid=11671&subid=729397&campid=134992&type=0.

FDA Revises Guidance on Premarket Validation for New Technologies

Drug manufacturers that use new, advanced technologies to ensure batch quality may not have to produce multiple validation batches before the initial distribution of a new drug, according to a revised guide released by the FDA. While the FDA has in some instances approved marketing applications before a firm has manufactured conformance or validation batches on a commercial scale, the new policy lists conditions under which a firm may be exempted from making the batches prior to premarket approval. The guide, a revision of an 11-year-old policy, also deletes a reference to three validation batches as being adequate minimum proof of product validity; a particular or specific number is no longer suggested. To see the new guide titled “Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval,” visit
http://www.fda.gov/ora/compliance_ref/cpg/cpgdrg/cpg490-100.html.

New FDA Initiatives to Facilitate Innovation and Collaboration in Drug Development

The FDA is proposing a series of new initiatives to encourage drugmakers and academic institutions to collaborate with the agency to remove obstacles along the drug development path so that innovative new products can reach patients as quickly and as inexpensively as possible, the agency said in a recent report. One goal of the initiative is the creation of a National Critical Path Opportunities list that will identify areas of product development most likely to benefit from innovative approaches and emerging technological advances. The agency also is hoping to draft a new generation of performance standards and predictive tools, such as new computer-based predictive models, biomarkers for safety and effectiveness, clinical evaluation techniques models, clinical trial endpoints and new assays. To see the report titled "Innovation or Stagnation? — Challenge and Opportunity on the Critical Path to New Medical Products," visit http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.pdf.

FDA Takes Steps to Protect Consumers from Counterfeit Drug Threats: RFID Considered

The Food and Drug Administration (FDA) is taking steps to keep the U.S. drug supply secure against increasingly sophisticated criminal efforts to introduce counterfeit drugs. The final report from the FDA task team highlights ways the agency believes will assure that the nation's drug distribution system can protect Americans from counterfeit drugs. These measures address six critical areas: securing the actual drug product and its packaging; securing the movement of the product as it travels through the U.S. drug distribution chain; enhancing regulatory oversight and enforcement; increasing penalties for counterfeiters; heightening vigilance and awareness of counterfeit drugs; and increasing international collaboration. As a result of the FDA’s counterfeit drug initiative, the bio-pharmaceutical industry may have to make dramatic and expensive changes in their packaging, labeling, and supply chain model to meet new requirements that will occur over the next three to four years, as well as the immediate requirements of the FDA Barcode Ruling issued February 25, 2004. It is important to note that the FDA has concluded that adoption and common use of RFID as the standard track and trace technology is feasible in 2007, and would provide better protection for citizens. For details, visit http://www.fda.gov.

What's New - March to April 2004 The following is a wrap-up of news of interest during the months of March to April 2004

What's New - March to April 2004
The following is a wrap-up of news of interest during the months of March to April 2004