LIMSource: What's New - January to February 2005

• Nuvotec Announces Acquisition of LIMS Related Software from RTS Enabling Technology
• Haematologic Technologies Selects LabPAS Adaptive LIMS
• Microridge to Introduce WedgeLink Upgrade at Pittcon
• Group Logic Ships ExtremeZ-IP 4.0
• Protedyne to Install Thirteen BioCube System Modules at GlaxoSmithKline Laboratories
• Protedyne Announces Enhancements to the BioCube System
• QIAGEN Expands Strategic Alliance with Protedyne Corporation Targeting Ultra High-Throughput Markets of Molecular Diagnostics and Pharmaceutical Research
• Agilent Technologies Reports First Quarter 2005 Results
• FDA Issues Revised Guidance on Reporting Drug Impurity Data
• Labtronics LimsLinkCDS Enables Interface of Agilent Cerity for Pharmaceutical QA/QC with Any LIMS
• Proposed FDA Reforms Address Phase IV Studies, Patient Protection Office
• FDA Gets Comments From Industry on NDIs
• Drugmakers Hope to Avoid Premarket Drug Safety Reforms, FDA Official Says
• FDA to Mull the Use of Color on Product Labeling and Packaging
• Atrium Research Introduces New Report on Managing Scientific Data
• ATL Enhances Sample Master Version 8.0 with Built-in NWA Integration
• BioAnalyte Appoints David Cousins to Corporate Communications Post
• GenoLogics Secures U.S. $5 million in Funding from OVP Venture Partners, Yaletown Venture Partners and Growthworks
• GenoLogics Introduces ProteusLIMS Version 2.0
• STARLIMS Joins the Fight against Tuberculosis
• GAMP to Issue Guide for Electronic Records, Signatures
• FDA Issues Guidance on Nonclinical Evaluations of Drug Combinations
• Thermo Electron Corporation Exhibits Expanded Informatics Product Line at Pittcon 2005
• Autoscribe Launches New Web Site
• Computing Solutions Launches LabSoft LIMS v8 Designed for Process Industries
• QSI Highlights Cost Effective LIMS for Contract Labs
• ATL to Exhibit and Present 11 Technical Papers at Pittcon 2005
• QSI Adds Functionality to WinLIMS for Petrochemical and Lubricant Applications
• New MSC-LIMS 3.0 Demo Unveils New Features
• Thermo Electron Adopts Process Intimacy Strategy
• WinLIMS Provides Enhanced Features for Environmental Laboratories
• New WinLIMS Enhancements Address Pharmaceutical Requirements
• STARLIMS Adds ISO/IEC 17025 Features
• P-Wave Releases Latest Version of LabCORE
• VelQuest and DCSS Partner to Provide Integrated Solution to Take Pharmaceutical Labs Totally Paperless
• National Instruments Announces NI Vision 7.1 Development Module
• Agilent Technologies Acquires Computational Biology Corp - Pioneer in Gene Regulation Analysis
• Eastman Chemical Company Awards Global CDS Contract to Scientific Software for EZChrom Elite
• Labtronics Releases BalanceTalk XL Version 5.1
• Labtronics Introduces New Analyzer Program (NAP) version 4.2.2
• Integration of SAP NetWeaver and Microsoft Visual Studio.NET
• New SAP Business One 2004 Adds Integration with Microsoft Excel
• Agilent Technologies Names William Sullivan as President and CEO; Ned Barnholt to Retire
• ATL Welcomes LIMS Expert Michael Kelly as Director of Product Development
• Former HHS Official Says FDA's Inherent Flaws Remain Unaddressed
• Final Rule on Records to Protect Food Supply

Nuvotec Announces Acquisition of LIMS Related Software from RTS Enabling Technology

Nuvotec USA Inc, an innovative and established technology commercialization company focused on products, services, and growth opportunities in environmental management, web-based compliance training, and information technology, has announced the acquisition of all LIMS and Laboratory Automation software from RTS Enabling Technology, Inc. This includes the enterprise laboratory information management system, OmniLIMS. OmniLIMS, now at Version 2.7.8, supports QA/QC and contract analytical laboratories for the general manufacturing and the environmental industries. Max White, Vice President of Software Products and Services, stated, “Nuvotec is excited about the prospect of incorporating OmniLIMS into our suite of products and services. Our LIMS team, mostly brought over from RTS, has a combined 40 years of combined LIMS development, implementation, project management and consulting experience, giving Nuvotec the ability to offer superior service both before and after the sale.” The Nuvotec OmniLIMS solution provides the means of managing, organizing, and reporting information from a multitude of laboratory analytical instruments in a user-friendly fashion. The main features include data integrity, detailed record auditing, and automation of key laboratory business functions in a laboratory configurable system. For details, visit http://www.nuvotec.com.

Haematologic Technologies Selects LabPAS Adaptive LIMS

Green Mountain Logic, Inc. (GML) and Haematologic Technologies, Inc. (HTI) have announced that HTI has selected LabPAS, Adaptive LIMS to support their growing laboratory operations. GML is a provider of FDA compliant software solutions for life sciences laboratories. HTI is a primary manufacturer of high quality coagulation proteins and research reagents. LabPAS is designed to solve the problems of complex, high-compliance, and high-throughput life sciences laboratories. LabPAS utilizes patent pending technology that allows lab managers to quickly configure data entry screens and workflows to map laboratory procedures. LabPAS tracks workflow configurations within a version control system to support laboratories in achieving FDA 21 CFR Part 11 compliance. Once configured, LabPAS automatically assigns work within easy-to-use browser screens for data entry or interface with instruments and third-party software tools. LabPAS features sample tracking, inventory management, ordering and reporting. LabPAS is unique in supporting customization without requiring source code licenses or excluding the lab from future product upgrades. “We’re very excited that Haematologic Technologies has chosen LabPAS as their LIMS platform” stated John Rosenblum, president of GML. “As part of this implementation, we are developing an environmental monitoring module which will be offered to our customers in the future. We’re looking forward to a close relationship with HTI where LabPAS’ breakthrough features are shown meeting the needs of this cutting-edge life sciences lab.” For details, visit http://www.gmlogic.com.

Microridge to Introduce WedgeLink Upgrade at Pittcon

Microridge will be introducing a new upgrade to their WedgeLink software keyboard wedge at Pittcon 2005. The WedgeLink upgrade features expanded data parsing and DDE. DDE is a much faster and more efficient way to pass large amounts of data to an application than through the keyboard input stream. The expanded data parsing capabilities will allow users to handle more complex input data. Microridge will also exhibit two new WedgeLink hardware wedges, along with their family of GageWay interfaces. GageWay interfaces connect any combination of digital gages (calipers, micrometers, digital indicators, etc.) and RS232 devices to an RS232 serial, USB or network port. For details, visit http://www.microridge.com.

Group Logic Ships ExtremeZ-IP 4.0

Group Logic, developer of network workflow software products, has announced the availability of ExtremeZ-IP File Server 4.0, a major upgrade of its Macintosh file connectivity software for Windows servers. The new version of ExtremeZ-IP introduces significant improvements in the product's scalability. ExtremeZ-IP is the first and only Windows-based file server solution to fully support both Mac OS X and Mac OS 9, making it an essential tool for mixed Macintosh and Windows computing environments. ExtremeZ-IP 4.0 introduces a re-architected internal structure and an advanced caching strategy that give customers: Immediate startup; New active-active clustering capabilities for better control of node resources; Reduced memory; Configuration of multiple virtual servers on the Windows cluster; Superior performance under load; Kerberos; Improved uptime and stability; and, Greater flexibility in failover options and functionality. "Every year, ExtremeZ-IP customers are storing more files and connecting more users to fewer servers. Many are installing to clusters to increase uptime,” says T. Reid Lewis, President of Group Logic. "So we’ve re-architected ExtremeZ-IP 4.0 to support millions of files on massive, multi-node clusters with zero indexing time offering greater control and stability." "Mac OS X delivers an incredible level of platform interoperability straight out of the box,” said Ron Okamoto, Apple’s vice president of Worldwide Developer Relations. "We are excited that Group Logic continues to develop robust file sharing solutions that build on Apple innovation to support a great user experience within enterprises using both Mac OS X and Windows." The ExtremeZ-IP 4.0 product line provides stable and compatible Windows-based file and print server platforms for Mac OS X and Mac OS 9users. It is the only Windows-based file server to support the latest version of the Apple File Protocol (AFP) and to be actively enhanced and maintained. The 4.0 upgrade is aligned to support Mac OS 10.3 and will be fully compatible with Mac OS 10.4 “Tiger” when it ships later this year. For details, visit http://www.grouplogic.com.

Protedyne to Install Thirteen BioCube System Modules at GlaxoSmithKline Laboratories

Protedyne Corporation, a leading laboratory automation supplier, has been selected by GlaxoSmithKline to provide 13 BioCube System modules in four of the company's facilities. Following the announcement of Protedyne as a Preferred GSK Supplier, the two companies signed an agreement to automate assay development in GSK laboratories located in Pennsylvania, North Carolina and the United Kingdom, as well as a system for gene cloning in the UK. For details, visit http://www.protedyne.com.

Protedyne Announces Enhancements to the BioCube System

Protedyne Corporation has announced new components for the BioCube System, the company’s sophisticated liquid, sample, and data handling automation platform. Newly available features of the BioCube System are:
(1) Vision Positioning System (VPS) which employs advanced machine vision technology to perform ultra-precise positioning by calibrating disposable tips on the pipettor to the actual plate well centers; (2) "LILY-Schedule" Scheduling Software which employs a unique steady state optimization algorithm that produces a production schedule regardless of the number of plates that will be used for each run; (3) A newly redesigned Plate Sealer that automatically adjusts for different height plates - anything from 384 PCR or low profile sample plates up to deep well blocks; (4) A new design of their high performance, two-position Centrifuge; (5) A new Plate Loader optionthat has expanded the BioCube System’s capacity as well as the possibilities for 3rd party integration; (6) and, an updated its Single Cassette Stacking System (SCSS) and High Capacity Stacking System (HCSS.) For details, visit http://www.protedyne.com.

QIAGEN Expands Strategic Alliance with Protedyne Corporation Targeting Ultra High-Throughput Markets of Molecular Diagnostics and Pharmaceutical Research

Protedyne Corporation, a premier supplier of ultra-high throughput industrial robotics for research, drug discovery, and testing laboratories and QIAGEN N.V., one of the world's leading providers of innovative enabling technologies and products for the separation, purification and handling of nucleic acids and proteins, have announced that they have expanded their strategic alliance to jointly market and cross-promote the use of Protedyne’s BioCube System in conjunction with QIAGEN’s QIAamp nucleic acid purification products as an integrated fully automated ultra high-throughput sample preparation system for high-throughput research and molecular diagnostics markets. In addition, QIAGEN will invest approximately US$ 2.0 million in Protedyne’s current series D financing. QIAGEN has been granted exclusive access to Protedyne’s high-throughput automation platform technologies for filter-based nucleic acid sample preparation. This strategic alliance is the result of a successful collaboration announced in June 2004. The first commercial system will be available during Q2 of 2005. Both parties expect to expand their collaboration to add and validate further customer applications. Protedyne’s BioCube System addresses the needs of customers requiring ultra-high-throughput and fully integrated preanalytical and analytical processing in molecular diagnostics and clinical research. For these applications, Protedyne has built a leading position. This expanded alliance addresses ultra-high throughput systems (larger than 600 samples per day) and therefore uniquely complements QIAGEN’s leading position in automated solutions extending from low-throughput platforms to high-throughput systems. For details, visit http://www.protedyne.com.

Agilent Technologies Reports First Quarter 2005 Results

Agilent Technologies Inc. has reported orders of $1.61 billion for the first fiscal quarter ended Jan. 31, 2005, 7 percent below one year ago. Revenues during the quarter were $1.66 billion, 1 percent ahead of last year. First quarter GAAP net earnings were $103 million, or $0.21 per diluted share, compared with $71 million, or $0.14 per share, in last year's first quarter. Excluding a net $3 million of restructuring charges and tax benefits, Agilent reported first quarter operating net income of $100 million, or $0.20 per share. On a comparable basis, the company earned $103 million, or $0.21 per share, one year ago. "I am pleased with Agilent's first quarter performance," said Ned Barnholt, Agilent chairman, president and chief executive officer. "We executed well, with very good operating discipline and cash generation in a challenging market environment. This quarter we continued to build on our strong foundation of product innovation and operational excellence that I believe will benefit Agilent for years to come." The company reported first quarter revenues of $1.66 billion, consistent with its expectations of $1.60 billion to $1.70 billion. Operating earnings, at $0.20 per share, were at the top of the guidance range of $0.14 to $0.21 per share. Gross margins were essentially flat compared with last year, despite much more difficult conditions in Agilent's semiconductor-related businesses, and operating expenses remained under very good control. The company generated another $100 million in free cash flow from operations during the quarter, bringing total cash on hand to $2.5 billion. Looking ahead, Agilent said it expects relatively flat second quarter fiscal 2005 revenues of $1.60 billion to $1.70 billion, reflecting the $70 million lower revenues associated with the divestiture of the company's camera module business. Operating earnings are expected to be in the range of $0.18 to $0.23 per share. For details, visit http;//www.agilent.com.

FDA Issues Revised Guidance on Reporting Drug Impurity Data

The FDA has made significant revisions to a November 1999 guidance that provides recommendations on the types of drug impurity data included with drug applications. The agency released a new draft guidance that supersedes the November 1999 guidance titled, "ANDAs: Impurities in Drug Substances." Both the revised and the original guidances provide recommendations on what chemistry, manufacturing and controls information to include regarding drug substance impurities when submitting abbreviated new drug applications (ANDAs), ANDA supplements or drug master files. The revisions were necessary, the FDA said, to update information on the listing of impurities, setting of acceptance criteria and qualifying impurities. Additionally, sections of the 1999 guidance needed to be removed because they are addressed in the International Conference on Harmonisation's "Q3A Impurities in New Drug Substances" (Q3A(R)) guidance, which offers guidance on impurities in drug substances for new drug applications. The FDA said many of the recommendations included in the Q3A(R) can also be applied to ANDAs. The sections of the 1999 guidance that were removed addressed the classification of impurities, the rationale for the reporting and control of impurities, analytical procedures, and reporting impurity content of batches. Drugmakers needing guidance on those subjects should refer to the Q3A(R) document. To view the new draft guidance, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/1998d-0514-gdl0003.pdf.

Labtronics LimsLinkCDS Enables Interface of Agilent Cerity for Pharmaceutical QA/QC with Any LIMS

Labtronics Inc. and Agilent Technologies Inc. has announced the availability of a secure, bi-directional
LimsLinkCDS interface that connects Agilent Cerity for Pharmaceutical QA/QC with any LIMS. The interface enables users to communicate and transfer data between the Cerity chromatography data system (CDS) and any LIMS efficiently, securely and in accordance with the U.S. Food and Drug Administration's ruling on electronic records and signatures (21 CFR Part 11). Cerity users can use the LimsLinkCDS/Cerity interface to query their LIMS for a list of samples that are due for testing. The LIMS worklist can then be automatically expanded to include special samples such as standards, controls and replicates. LimsLinkCDS formats the completed sequences and transfers them to the Cerity CDS using the secure Cerity XML Import interface. The LimsLinkCDS/Cerity interface can capture any printed report from Cerity and transfer the report data directly to the LIMS, with a single click of the mouse. The integration of LimsLinkCDS and Cerity for Pharmaceutical QA/QC provides Cerity users with a secure, off-the-shelf solution for LIMS interfacing that can be configured through a set-up menu, without the need for a customization project. Agilent and Labtronics will work together on the successful deployment of the solution in their customers' environments. For details, visit http://www.agilent.com or http://www.labtronics.com.

Proposed FDA Reforms Address Phase IV Studies, Patient Protection Office

Two prominent Democratic senators have announced FDA reform plans — one calling for the government to require certain postmarketing studies on drug products, and another proposing the creation of a new drug safety watchdog office under the auspices of the FDA commissioner. The separate bills, by Sens. Edward Kennedy (D-Mass.) and Christopher Dodd (D-Conn.), aim to address recent drug safety issues, including the discovery of adverse cardiovascular events related to the use of Cox-2 inhibitors and the link between antidepressant use and suicidal behavior in children. Kennedy's Affordable Health Care Act, S. 16, would authorize HHS to require drug sponsors to conduct Phase IV studies if certain safety issues surface about the product after it's approved, including through the FDA's MedWatch postmarket surveillance system, epidemiological studies or scientific literature. Dodd's proposed Patient Protection Act of 2005, calls for establishing a new Office of Patient Protection (OPP), which would remain in the FDA but would report directly to the FDA commissioner. OPP would have independent authority to act to protect patients, according to Dodd's announcement. The bill creates a new "watchdog office in the FDA" that could pull drugs off the shelf if they are deemed to be unsafe for patients, he said. Dodd would appropriate $100 million annually to fund OPP. For details, visit http://www.fda.gov.

FDA Gets Comments From Industry on NDIs

The American Botanical Council, the American Herbal Products Association and the Utah Natural Products Alliance recently filed public comments with the FDA, responding to the agency's request for comments on the premarket notification program for new dietary ingredients (NDIs), according to NPI Center. The comments were prepared in response to a notice filed by the FDA in the Federal Register Oct 20, 2004, in which FDA announced a public meeting to be held on Nov 15, 2004, at which various parties were able to present their views on how the FDA should regulate NDIs. The agency allowed the public to file written comments on NDIs until Feb 1. For details, visit http://www.fda.gov.

Drugmakers Hope to Avoid Premarket Drug Safety Reforms, FDA Official Says

As lawmakers and the FDA mull over proposals to address recent drug safety concerns, pharmaceutical firms are hoping that any potential fix will not focus on the premarket side of the equation, according to a top FDA official.
Potential changes to the premarket workup and approval standard for pharmaceutical products is the greatest concern to industry, said Janet Woodcock, the FDA's acting deputy commissioner for operations. "They think it could result in prolonging drug development ... and even affect the probability of success," she said at the World Health Care Congress in Washington, D.C. Woodcock warned that there is a trade-off between developing greater certainty during the premarket phase and approving drugs in a timely fashion, she said. Still, Congress or the FDA may be spurred to take some action in light of recent drug safety issues, Woodcock said, including the links between antidepressant use in children and suicidal behavior, and increases in cardiovascular events among patients taking Cox-2 inhibitors. The furor over these events has undermined public confidence in the FDA's regulatory process and has raised concerns about the structure and integrity of the drug review process, Woodcock said. "Periods of perception of crisis in drug regulation frequently lead to changes," she added. But Woodcock also noted that any potential premarket modifications are unlikely to affect some products, including short-term treatments such as antibiotics, as well as drugs that treat life-threatening illnesses. It is the long-term treatments for non-life-threatening symptoms that raise the biggest questions about the kind of evaluation that is needed, she said, including what kind of clinical trials to conduct and the number of trials that should be required. For details, visit http://www.fda.gov.

FDA to Mull the Use of Color on Product Labeling and Packaging

The FDA has issued a public call for information on the use of color on pharmaceutical labeling and packaging to determine if the practice is one that warrants further action from the agency. As part of this effort, the Center for Drug Evaluation and Research has scheduled a public hearing for March 7 to discuss a number of general issues related to the use of colored labeling and packaging. Color is typically used on labeling and packaging to help classify, differentiate and identify pharmaceutical products. The main purpose of the March meeting is to gather information from the public so the FDA can weigh the pros and cons of color use, FDA Director of the Division of Medication Errors and Technical Support Carol Holquist said. Holquist said the FDA currently does not have enough information to make an informed decision about what steps, if any, the agency should take on the issue.
Holquist noted that if the reaction from the public was overwhelmingly negative about the use of color on pharmaceutical packaging, the agency might consider developing guidance on the issue. But until then, the FDA "simply doesn't have enough information to go anywhere with it," she said. To view a copy of the meeting announcement, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/05n-0036-nm00001.pdf.

Atrium Research Introduces New Report on Managing Scientific Data

Atrium Research has introduced a new research study, Managing Scientific Data: The Data Lifecycle. This 250 page in-depth report looks at the technology, architectures, standards and products for the collection, storage, utilization and archiving of scientific data. Over sixty pages are devoted to reviewing and rating sixteen commercially available data management products. 70 charts, tables and figures illustrate key points. The explosive growth of scientific data has forced organizations to look at new ways to control and protect knowledge assets. Fundamental concepts of system architectures, the data lifecycle, storage, metadata management, searching, mining, security, and retention are presented in a way that is both understandable and informative. Newer technologies, such as XML Web services, the Semantic web, PKI, grid computing, and RSS, are discussed in detail on how they can help organizations realize their vision of electronic R&D. The report also looks at the development and progression of industry standards in ontologies and data formats. Common user needs, legal considerations, and best practices for system implementation are covered to assist users in the development of their own project requirements. Strategic market analysis, drivers, restraints, benefits, and trends of scientific data management are also presented. For details, visit http://www.atriumresearch.com.

ATL Enhances Sample Master Version 8.0 with Built-in NWA Integration

Accelerated Technology Laboratories, Inc. (ATL) has announced that Sample Master Version 8.0 LIMS now features tighter integration with Northwest Analytical Inc.’s (NWA) Quality Analyst software. NWA specializes in providing SPC charting and analysis software for a wide variety of industries, enabling a better understanding of processes, enhancing productivity and quality. NWA’s flagship product, Quality Analyst is a powerful, flexible, and easy to use statistical package. It enables a wide range of users to graphically analyze process behavior and judge the impact of process-improvement decisions. Sample Master with embedded Quality Analyst functionality allows users to easily create detailed charts including Capability Histogram, Pareto, Regression, Run Charts, Scatter Diagrams and Variable charts. This will allow ATL’s LIMS users to better manage their processes and increase efficiency and productivity. For details, visit http://www.atlab.com.

BioAnalyte Appoints David Cousins to Corporate Communications Post

BioAnalyte has announced that David Cousins will lead its corporate communications effort as the company rolls out its Trawler Nets product through the spring season of national biotechnology conferences. Cousins holds a 1989 graduate of Gorham High School and a 1994 business bachelors degree from of the University of Southern Maine and has led Night and Day, a graphical design consulting company since 2002. Other firms employing Cousins for graphic design consulting include Brims Ness Corporation, On-Course Financial Planning, Fogstone Enterprises, O’Hare Associates and Signature Capital. Trawler, a software product that simplifies data analysis on unwieldy genomic and proteomics data sets, is available for free from the company’s web site. Automating this process -- trawling the data – is available with a per-data-set license called a Net. For details, visit http://www.bioanalyte.com.

GenoLogics Secures U.S. $5 million in Funding from OVP Venture Partners, Yaletown Venture Partners and Growthworks

GenoLogics Life Sciences Software Inc., developer of an open bioinformatics software platform that assists life science and pharmaceutical research laboratories manage, integrate and analyze enormous volumes of scientific data, has completed a $5 million (U.S.) round of financing. Co-led by Seattle headquartered OVP Venture Partners and Vancouver, B.C. based Yaletown Venture Partners, OVP is the first venture firm in the Northwest U.S. to fund a Bio-IT company in Western Canada. Yaletown and OVP are also joined in the Series A round by the Working Opportunity Fund managed by GrowthWorks Capital Ltd. of Vancouver, B.C., one of Canada’s largest fund
managers. "With the closing of our Series A funding, GenoLogics is in an ideal position to scale the company
to satisfy the growing demand for our technology,” said Michael Ball, CEO of GenoLogics. GenoLogics is building an open bioinformatics software platform for the life sciences global marketplace, initially specializing in the emerging high growth field of proteomics research. Studies indicate many aspects of proteomics research (and specifically the study of proteins within cells), are focused around early disease detection including cancer. "An integrated open software platform is needed to help the life sciences sector adjust to the explosion taking place in the market,” said OVP General Partner Chad Waite. “GenoLogics is one of the very few players to develop an environment which will create an integration standard for all instruments in the market. The company also is our sixth Northwest investment in Bio-IT within the last 6 months.” The GenoLogics flagship product for proteomics, ProteusLIMS, provides systems for sample tracking, lab management, instrument integration, and workflow and scientific data management for gels, mass spectrometry and protein searches. Researchers in academic and commercial proteomics laboratories can analyze and integrate data, easily collaborate with peers, and quickly turnaround results to accelerate development and advances in health research. For details, visit http://www.genologics.com or http://www.ovp.com or http://www.yaletown.com or http://www.growthworks.ca.

GenoLogics Introduces ProteusLIMS Version 2.0

GenoLogics Life Sciences Inc. has announced the introduction of ProteusLIMS Version 2. software platform for proteomics. ProteusLIMS provides sample tracking, lab management, instrument integration, and proteomics focused workflow and data management for gels, mass spectrometry and protein searches. Significant innovations featured in this next version release of ProteusLIMS make it a leading system for proteomics, providing labs with solutions that improve productivity and scientific decision making. Version 2.0 introduces significant new functionality in integrating with analytic software for gels and protein search, as well as new features to improve reporting, usability and workflow support for new experimental techniques. ProteusLIMS seamlessly integrates with Progenesis, an industry leading 2D gel analysis software from Nonlinear Dynamics. This development enables labs to pull experiment data and in-depth gel analysis together with other information and put it in context with the rest of the research for more sophisticated analysis and decision making. For details, visit http://www.genologics.com.

STARLIMS Joins the Fight Against Tuberculosis

STARLIMS Corporation, a leading global provider of Laboratory Information Management Systems, (LIMS), has unveiled a joint effort with Lilly MDR-TB partnership in the battle against the expanding crisis of multi-drug resistant tuberculosis (MDR-TB), a virulent mutated type of tuberculosis (TB) that is difficult to treat, and
therefore much more likely to spread. The Lilly MDR-TB Partnership is a uniquely comprehensive initiative with the World Health Organization (WHO), the U.S. Department of Health and Human Services' Centers for Disease Control and Prevention (CDC), Brigham and Women's Hospital (BWH), an affiliate of Harvard Medical School, the
International Council of Nurses (ICN) and Purdue University to increase the number of trained personnel and drugs available to treat the expanding crisis of MDR-TB. Through funding from Lilly, the CDC have begun the implementation of STARLIMS as a platform for extensive laboratory-based electronic surveillance of patients resistance to drugs used for treating MDR-TB, in clinics throughout Russia and Kazakhstan. STARLIMS is an enterprise level information system that brings together all public health laboratory activities into a single platform, offering comprehensive reporting, surveillance, and networking capabilities compatible with national and international standards. Public health solutions from STARLIMS are designed as a platform for linking between
regional public health partners working under the PHIN framework, HL7 messaging protocols and using LOINC and SNOMED as the common vocabulary for test names and observations. This functionality enables cross site sample transfer and data exchange. "The CDC and STARLIMS partnership allows us to apply LIMS technology to monitor treatment effectiveness. This is a very critical component of our whole effort to address MDR-TB", stated Dr. Gail Cassell, vice president, scientific affairs and distinguished research scholar for infectious
diseases, Eli Lilly and Company. For details, visit http://www.lillymdr-tb.com or http://www.starlims.com.

GAMP to Issue Guide for Electronic Records, Signatures

The Good Automated Manufacturing Practice (GAMP) Forum, a division of the International Society for Pharmaceutical Engineering (ISPE), will release its "GAMP Good Practice Guide: Risk Management Approach to Electronic Records and Signatures," on February 18 at an ISPE conference in Tampa, FL. "The guide is the culmination of more than a year's effort by the GAMP Europe and Americas steering committees," committee member Michael Wyrick said. "The document was developed by GAMP at the request of the FDA. The agency was seeking industry risk-based guidance approaches to support the scope and application changes advocated by the agency in its August 2003 21 CFR Part 11 guidance document." The electronic records guide provides comprehensive guidance on meeting current regulatory 21 CFR Part 11 expectations for compliant electronic records and signatures, including requirements for record integrity, security and availability throughout the required retention period. "The guide documents how to meet these requirements through a combination of validated, well-documented systems, together with the application controls appropriate to the impact of the records concerned and the risks to those records," said Wyrick, senior director of validation and good manufacturing practices compliance services for Washington Group International in Indianapolis. For details, visit http://www.fda.gov.

FDA Issues Guidance on Nonclinical Evaluations of Drug Combinations

The FDA has released a draft guidance providing recommendations on nonclinical safety evaluations to support the clinical study and approval of drug combinations, including fixed-dose combination products, co-packaged products and adjunctive therapies. The draft guidance includes recommendations for three subgroups of drug combinations: combinations involving only previously marketed drugs; combinations including one or more new molecular entities (NMEs) and one or more previously marketed drugs; and combinations consisting of more than one NME. The FDA said it elected to discuss the drug combination types separately because nonclinical studies may differ for each type based on the toxicologic and pharmacokinetic profiles of the individual drugs, the treatment indication or indications, or the target population. To view the draft guidance, titled "Nonclinical Safety Evaluation of Drug Combinations," go to http://www.fda.gov/OHRMS/DOCKETS/98fr/2005d-0004-gdl0001.pdf.

Thermo Electron Corporation Exhibits Expanded Informatics Product Line at Pittcon 2005

Thermo Electron Corporation, a world leader in analytical instruments, will showcase its expanded Laboratory
Software Solutions offering at Pittcon 2005 at the Orange County Convention Center in Orlando, FL, February 27 - March 4. A full range of LIMS and integrated chromatography data systems (CDS), including award-winning commercial off-the-shelf (COTS) LIMS solutions for the pharmaceutical industry will be on display at Booth # 2917. Thermo's exhibit will feature its world-class SampleManager LIMS, Nautilus LIMS and Atlas CDS solutions along with complementary laboratory software that was added to the company's portfolio with the September acquisition of InnaPhase Corporation, a provider of innovative software products for the pharmaceutical industry.
Thermo's expanded portfolio now provides a full range of software solutions to take pharmaceutical corporations from discovery through to manufacturing. These include Watson LIMS, the industry standard for bioanalytical labs at top 20 pharmaceutical companies, biotech and contract research organizations worldwide, and Galileo LIMS, designed specifically in vitro testing in early drug discovery and development, as well the Enterprise Pharmacology (EP) Series and Kinetica, database analytical tools for pharmacokinetics and pharmacodynamics. Thermo also announced that 12 technical presentations on informatics and services were accepted by the Pittcon committee. In addition to its Informatics solutions, Thermo will be exhibiting a wide range of industry leading instrumentation, software and services at Booth # 2917. Pittcon highlights include user-friendly and cost-effective turnkey solutions for the modern laboratory with an emphasis on easy implementation, performance and integration .For details, visit http://www.thermo.com/informatics

Autoscribe Launches New Web Site

Autoscribe has launched a new web site focused exclusively on the company's LIMS, scientific and business data management systems and services. The web site was created based on input from global customer and prospect representatives and staff. The result is a comprehensive online resource for current customers and prospective Autoscribe users. Users will find a variety of topical industry-related news, including a listing of Autoscribe partners and an overview of industry exhibitions, conferences and meetings. Other features include links to regulatory sites, partner and customer sites, viewer and plug-in downloads, interesting scientific and other website links, documentation, white papers, etc. For details, visit http://www.autoscribe.co.uk.

Computing Solutions Launches LabSoft LIMS v8 Designed for Process Industries

Computing Solutions, Inc. has announced the release of LabSoft LIMS v8, which offers features that increase the efficiency and accuracy of logging samples and recording test results. These new features includes support for Test Plans; Enhanced Instrument Validation Features; Ability to store and use historical control limits in addition to the current control limits; and more. For example, when logging a sample, the new Test Plan feature suggests a pre-qualified group of tests to be included based on any property of the sample. The Enhanced Instrument Validation Features, on the other hand, provide advanced information on the validation of the instrument used to obtain the test results. This allows the user to drill down on a process result and not only view the instrument that was used to obtain the result, but view a control chart of the actual validation (i.e. standards) results. For details, visit http://www.LabSoftLIMS.com.

QSI Highlights Cost Effective LIMS for Contract Labs

Industry is looking more and more to outsourcing its analytical and testing needs to contract laboratories. This places on those labs a need for a flexible yet structured and error-free means of handling and reporting sample information and results. A LIMS can provide all this, but some laboratories have been reluctant to invest because of concerns about the time and costs associated with specification, commissioning and the perception that they need a tailor-made system. According to Clive Collier of QSI, their WinLIMS technology has developed and matured to the extent that all the functionality required by contract laboratories -- be they environmental, micro or QA/QC -- is available "out-of-the-box". Said Collier "Of particular interest to contract laboratories will be WinLIMS' state-of-the-art reporting tools. We now offer cost-effective distributed web reporting, whereby a number of a laboratory's customers can simultaneously interrogate the system directly, on line, for their results. This is totally secure, so that customers have access only to their own information. They can even remotely log-in their samples, saving time and cutting out transcription errors. The standard functionality combines all the flexibility needed to handle ad hoc and routine customer requests in a structured yet accessible and secure way. Sample and business information are integrated, so that invoicing and details like addresses and contact details are securely linked to sample data like perhaps a customer's own special methodology or QC limit values". For details, visit http://www.qsiuk.com.

ATL to Exhibit and Present 11 Technical Papers at Pittcon 2005

Accelerated Technology Laboratories, Inc. (ATL) will be exhibiting new features in Sample Master XP 8.0 and ScreenIT Pro LIMS in booth #2153 at Pittcon 2005. The annual conference is scheduled for February 27th to March 4th at the Orange County Convention Center in Orlando, FL. New features for Sample Master XP 8.0 LIMS include: Web based sample login that allows customers to submit their sample information over the web before the samples arrive; New AutoEmail and AutoFax functions for reports; Save complex queries and running with new “one click” function; Calculations across multiple tests; Enhanced QC Batch creation; Automatic addition of Data Qualifiers for samples and QC; Improved Time Tracking functionality; and more. ScreenIT Pro Automated Manufacturing Analysis System is a user configurable LIMS for raw materials and manufacturing laboratories. New features include: Enhanced Workload; Enhanced Production and Backlog Reports; Certificates of Analysis; SPC Charts and multiple level specifications with visual quality alerts and e-mail notification; and much more. In addition, ATL will be presenting 11 technical papers at Pittcon 2005. For details, visit http://www.atlab.com.

QSI Adds Functionality to WinLIMS for Petrochemical and Lubricant Applications

QSI has developed extensive additional functionality for their WinLIMS package to meet the special needs of the Petrochemicals and Lubricants industries inside and outside the laboratory. When combined with the power of the core WinLIMS, a unique solution is created for both upstream and downstream sectors without the need for extensive (and expensive!) custom code. For the lubricants industry, there are tools for blending control and formulation management, including blend optimisation. Used oil analysis is a service often provided by lubricant suppliers, and WinLIMS provides a complete data management solution for this sector, including the ability to generate complete historical records, apply different rules for different customers and allow free text engineers’ comments to be incorporated in the report. For the process sector, tank farm management facilities give production and the laboratory immediate access to the status of each tank and its contents. Overall management and control of the many samples that have to be taken to monitor continuous and batch processes is much simplified by the ability of WinLIMS to create a sampling schedule and log in samples automatically. WinLIMS has also been successfully integrated with many of the industry-standard ERP systems, delivering fewer errors and improved efficiencies. For more details visit http://www.qsiuk.com.

New MSC-LIMS 3.0 Demo Unveils New Features

Prospective users may now download MSC-LIMS’ interactive Version 3.0 demo with no obligation, directly from the MSC web site. Labs researching LIMS options may explore MSC-LIMS’ features in detail without “registering,” privacy guaranteed. The new MSC-LIMS Version 3.0 demo is interactive. Users navigate through each component, following a logical sequence of annotated screen captures and report examples. Installation of the demo is unobtrusive: users follow download directions, and specify where the demo should be installed. A desktop shortcut icon is optional. Uninstalls are thorough, because no hidden files are added to Windows folders. After viewing the demo, prospective users may contact MSC-LIMS developer Mountain States Consulting to schedule a live, on-line demo of the complete system. Prices start at $500 per user per year for a complete Annual Subscription License. MSC-LIMS is a complete, Access-based LIMS designed for small to mid-sized labs. For nearly a decade, MSC-LIMS has helped environmental, food testing, and petrochemical laboratories maintain well organized, secure, instantly accessible, and easily reported lab data. A detailed price list, all product literature, example LIMS and Excel reports, and the downloadable MSC-LIMS Demo are available at http://www.msc-lims.com.

Thermo Electron Adopts Process Intimacy Strategy

Thermo Electron has announced that it has embraced a strategy called “Process Intimacy” to leverage its detection technologies in the process industries. Thermo’s Process Instruments Division offers solutions beyond measurement of pressure, temperature, flow, and level with analytics that enable its customers to improve productivity and meet regulatory requirements. The intent is to provide continuity between online process applications and the development laboratory. The practice of building quality into products rather than testing for it at the end as prescribed by the US Food & Drug Administration’s Process Analytical Technology (PAT) initiative will require increased implementation of inline measurements to better understand and control the process during manufacturing. The benefits of inline measurement include improved product quality, reduced cost of manufacture, and increased efficiency are applicable across the process industries. Benefit-driven analytical solutions focusing on in-built quality and high productivity will be required for critical processes in the process industries. The in-depth process knowledge provided by inline devices enables performance to be measured in real-time against performance targets to keep manufacturers on track or make mid-course corrections if required. Performance values derived in real-time can be used by process operators to improve current plant performance as well as be integrated into higher-level enterprise resource planning (ERP) systems to improve future resource allocation decisions. Thermo’s Measurement and Control Division offers numerous solutions for use outside the laboratory including analytical and traditional instrumentation for process and environmental applications in the metals & mining, oil & gas, chemical & petrochemical, food & beverage, and pharmaceutical industries. For details, visit http://www.thermo.com/informatics

WinLIMS Provides Enhanced Features for Environmental Laboratories

Environmental laboratories, especially contract labs, can be asked to handle perhaps the most diverse range of sample types of any laboratory – such as soils, waters, effluents, toxic wastes, emissions, swabs and occupational health samples. Furthermore the results can have legal implications, so it is vital that sample recording, reporting and auditing are as accurate as the analysis itself. QSI LIMS products have been serving environmental laboratories for many years, and the latest WinLIMS incorporates extensive functionality for the environmental analysis sector. Remote Sample Login, in conjunction with automatic Routine Sample Scheduling, simplifies and speeds the task of sample entry. A sample can be taken at a remote location, logged directly into the WinLIMS database via a wireless link or the WWW. The sampling routine and analytical parameters, and any other relevant information, can be automatically predefined, eliminating the need for manual data entry with its attendant errors. The sheer volume of samples processed at many environmental laboratories makes automated analysis practically essential. The WinLIMS Interlink module provides a by-directional interface not only to these instruments but also to any on-line monitors in use, providing improved data accuracy and significant time savings. QA/QC procedures, essential to demonstrate the validity of results can also be scheduled and operated via WinLIMS. Crystal Reports is the preferred report generator, and QSI’s specialist support for this tool helps clients conform to any mandatory reporting protocols. For the contract laboratory, there are comprehensive quotation and invoicing facilities as well. For details, visit http://www.qsiuk.com.

New WinLIMS Enhancements Address Pharmaceutical Requirements

The Pharmaceutical industry is one of the most tightly regulated in the world. The audits carried out on pharmaceutical companies scrutinise not only their laboratory procedures, but also any LIMS in use. Recent software enhancements to QSI’s WinLIMS package provide additional tools to aid regulatory adherence.
Recently announced at the QSI European User Group meeting, held at the company’s new European Headquarters near Aylesbury, England, these new facilities include enhanced audit trails and security controls. The audit trailing logs every change made to a data record, be that changing a value, data deletion or any other modification, and also registers the circumstances of the change – who made it, when and why. The security facilities enable comprehensive configuration of privileges, and include facilities like the detection of failed login attempts and monitoring staff training levels – so that an unqualified person would not be allowed to process a particular method, for example. Also included is a facility for Version Control of specifications and methods, enabling precise identification of the quality controls that were in place at any time in the past. The use of electronic signatures to authorise transactions is covered by the FDA’s 21 CFR Part 11. WinLIMS provides facilities for configuring and applying electronic signatures in excess of the regulatory requirement. Other facilities for the Pharmaceutical laboratory are the “Shelf-Life Testing Option” that holds user-defined testing protocols and informs the laboratory when to withdraw samples from storage for testing. Formulation Management and Complaints & Corrective Actions are other tools that used with the WinLIMS core functionality, provide a unique solution for pharmaceutical laboratory without the need for extensive custom code. For details, visit http://www.lims-software.com.

STARLIMS Adds ISO/IEC 17025 Features

STARLIMS has integrated ISO/IEC 17025 laboratory accreditation features into its LIMS solution. Labs can use these new features to accelerate their ISO accreditation process. STARLIMS can electronically document test method versions, analyst training certification, instrument standards and maintenance, material management and storage conditions, chain of custody, outsourced services, as well as maintain report templates and distribution records in accordance with ISO requirements. The integrated workflow manager is capable of automatically linking related information to produce a sample traceability matrix as required by ISO. Quality Management Systems, Inc., an independent organization specializing in sector-specific ISO assessment and registration, has determined laboratories using STARLIMS can effectively reduce the time and costs associated with accreditation due to the comprehensiveness of the STARLIMS solution. For details, visit http://www.starlims.com.

P-Wave Releases Latest Version of LabCORE

P-Wave, Inc., a leader in web-based applications and document and records management solutions for regulated industries, has announced the release of LabCORE V2.01, a web-based document and workflow management application. V2.01 offers a combination of five new and enhanced features – a Flexible Storage File System, the ability to create ‘customized clients,’ archiving and retrieving e-mails, an electronic signature capability, and a searchable audit trail – for laboratories or other FDA and EPA regulated companies who are struggling to comply with regulations and who need to control and manage huge volumes of documents and data. LabCORE’s Flexible Storage File System (FSFS) enhancement allows laboratories to store extremely large numbers of documents in multiple locations, and yet have all documents centrally managed from LabCORE’s hub. This enhancement overcomes the limitation of having to store all documents on a single system. It also allows files to be rapidly retrieved from many different systems. The ‘custom client’ capability allows for the creation and integration of customized user programs and specialized interfaces to facilitate document and records management. This feature lets users upload a single file with many documents in it or to import multiple documents into LabCORE by merely “dragging and dropping” them into the appropriate folder. While the initial version of LabCORE handled nearly every file type, P-Wave recognized the need to include the ability to archive and retrieve e-mail. With LabCORE V2.01, users can now import, archive, and retrieve e-mails as easily as they do other file types. P-Wave has also enhanced LabCORE’s ability to control document access and to track all system activity. Included in LabCORE V2.01 is a fully 21 CFR Part 11 compliant electronic signature capability, whereby several individuals can digitally sign a document. Finally, LabCORE V2.01 has an enhanced searchable audit trail that logs and archives all actions performed within LabCORE, including editing, adding, viewing and signing a document. LabCORE V2.01 will be exhibited for the first time at PITTCON 2005 in booth #2546. For details, visit http:// www.lab-core.com.

VelQuest and DCSS Partner to Provide Integrated Solution to Take Pharmaceutical Labs Totally Paperless

Digital Consulting & Software Services, Inc. (DCSS), a firm providing enterprise-wide consulting services to the regulated industries, and VelQuest Corporation, the developer of SmartLab “method-centric” automated lab compliance platform, have announced a strategic alliance to provide fully integrated solutions that permit SmartLab to integrate seamlessly with other laboratory software products to provide unparalleled productivity and compliance in pharmaceutical labs. Today, the US pharmaceutical industry spends approximately $90 billion on manufacturing. Productivity improvements of only 5% could yield a savings of over $4.5 billion annually. “A major initiative in most companies is the drive to eliminate the routine, non-value added and error-prone tasks through automation”, said Ken Rapp, President and CEO of VelQuest. “A key element in most regulated companies is that a significant amount of resources are dedicated to regulatory compliance functions. Within the quality operations, the drive to “go paperless” is anticipated to create huge operational benefits yielding millions of dollars in efficiency gains”. This e-manufacturing/QC environment will enable immediate communication between the various data islands ranging from product and process development through final quality control lab results and batch release documentation, providing enterprise-wide intelligence that can react together to improve overall product release cycle times. By combining VelQuest Corporation’s ePMCtm platform and DCSS’ integration services, pharmaceutical companies can quickly implement an automated method execution and data management solution in a totally paperless environment. For details, visit http://www.velquest.com or http://www.dcss.com.

National Instruments Announces NI Vision 7.1 Development Module

National Instruments has announced the NI Vision 7.1 Development Module, which features hundreds of vision tools for engineers and scientists using NI LabVIEW, LabWindows/CVI, C/C++ or Visual Basic to create vision applications that inspect, align, identify and measure objects. With the software, engineers and scientists can access new algorithms such as geometric matching, object classification, optical character recognition (OCR) and 2D bar code readers to quickly locate, sort and track objects even under poor imaging conditions. With geometric matching, engineers and scientists can locate objects that are best described by edges and shapes rather than textures and shades, even when under poor lighting conditions or partially obstructed. Geometric matching also is effective at locating objects that appear to change scale, as in applications such as robotic guidance and product assembly where the distance between the camera and object varies. For details, visit http://www.ni.com.

Agilent Technologies Acquires Computational Biology Corp - Pioneer in Gene Regulation Analysis

Agilent Technologies Inc. has announced its acquisition of Computational Biology Corp., a biotech pioneer in ChIP-on-chip, a microarray-based technique for understanding gene regulation in disease. The acquisition gives Agilent exclusive access to the critical patent and intellectual property for ChIP-on-chip analysis that will enable the company to provide unique microarray solutions for disease research, drug discovery and drug development.
Computational Biology Corp., based in Cambridge, Mass., was founded by Drs. Richard Young and David Gifford of the Massachusetts Institute of Technology and biotechnology executive Dr. Heidi Wyle. Young is a professor at the prestigious Whitehead Institute for Biomedical Research, a leader in the study of gene regulatory networks, and the primary inventor of ChIP-on-chip. Gifford, a professor in MIT's Electrical Engineering and Computer Science department, is an expert in computational biology and in the development of software algorithms for biological analysis. Both will remain professors at MIT while consulting with Agilent to support the ongoing development of commercial solutions for ChIP-on-chip. Within six months of the acquisition, Agilent plans to open a center in Cambridge to enable close collaboration with Young and Gifford, Whitehead and MIT, as well as other collaborators and customers in the region. It will include an Agilent demonstration center for genomics, proteomics and informatics. ChIP-on-chip uses chromatin immuno-precipitation (ChIP) to discover how regulatory proteins interact with the genome of living cells. Regulatory proteins bind to genomic DNA to control chromosome replication and gene activity, thereby functioning as switches in the regulatory circuitry of cells. This circuitry is largely uncharted, and its discovery will help researchers develop new drugs targeting the proteins and pathways that play a role in disease. As part of the acquisition, Agilent has acquired exclusive access to U.S. patent 6,410,243, Chromosome-Wide Analysis of Protein-DNA Interactions. This patent is the property of the Whitehead Institute and licensed exclusively to Computational Biology Corp. For details, visit http://www.agilent.com.

Eastman Chemical Company Awards Global CDS Contract to Scientific Software for EZChrom Elite

Scientific Software, Inc. has announced that the Eastman Chemical Company has named Scientific Software as the preferred supplier for Chromatography Data Systems at all Eastman operations worldwide. The selection was based on a major evaluation conducted by Eastman among major CDS suppliers to address its technical and strategic needs in the chromatography area. The Scientific Software offering based on its award-winning EZChrom Elite Chromatography Data System will provide Eastman facilities worldwide with a scalable and flexible data system capable of working with Eastman’s current and future chromatography instrumentation. EZChrom Elite is a scalable chromatography data system with integrated instrument control for more than 260 different GC and HPLC manufacturers. It provides a complete set of software routines for chromatography data analysis and reporting. For details, visit http://www.eastman.com or http://www.scisw.com.

Labtronics Releases BalanceTalk XL Version 5.1

Labtronics Inc. is pleased to announce the release of BalanceTalk XL version 5.1. The BalanceTalk XL software is designed to integrate serial output such as RS232 and TCP/IP capable instruments/devices directly with the Microsoft Excel application eliminating data entry and errors, significantly improving sample and test throughput.
The software contains a library of pre-configured interfaces supporting over 400 instrument models including balances, pH/ISE/conductivity meters, density meters, force/stress gauges, spectrophotometers and more for simplified setup.Fully supporting Windows NT v 4.0, 2000 and XP Professional operating systems with either Microsoft Excel 97, 2000, XP or 2003 installed, BalanceTalk XL is the ideal solution to connect any serial instrument or device directly with Microsoft Excel. With an interface not relying on the cursor, the software supports numerous interfaces to a single computer and same Excel file simultaneously, while allowing users to work in other programs while data collection is active. The BalanceTalk XL software has been enhanced to meet a number of application and instrument specific requirements such as a new Time and Date stamp macro, Place Data feature, Filter and Discard Data to handle erroneous instrument outputs. Timed Interval applications now also have the ability to specify the exact number of data points to be collected. For details, visit http://www.labtronics.com.

Labtronics Introduces New Analyzer Program (NAP) version 4.2.2

Labtronics Inc. has released their New Analyzer Program (NAP) version 4.2.2 for Technicon AAIIs, Alpkem RFAs or any continuous flow analyzer with a 0-5 Volt analog output. The NAP software analyzes output in continuous flow colorimetric applications, significantly increasing sample throughput and accuracy over conventional methods. Peaks are marked based on user-defined settings, marking special peaks and flagged samples on the graph for easy viewing and zoom-in real-time editing. Results are calculated based against 1st, 2nd or 3rd order standard curves, with a number of peak correction capabilities available such as Drift and Carry-over. QC Charting allows for results to be output to any network printer, ASCII text file in any format or Excel template for further analysis. Capable of interfacing up to 6 detectors simultaneously through its' external USB analog-to-digital data acquisition box, NAP v 4.2.2 improves the efficiency of laboratories running continuous flow instruments. NAP is also ideal for interfacing any 0-5 V analog instrument or device where peak analysis is required. For details, visit http://www.labtronics.com.

Integration of SAP NetWeaver and Microsoft Visual Studio.NET

Microsoft Corp. and SAP AG have announced availability of the Portal Development Kit for Microsoft.NET (PDK for .NET) within SAP NetWeaver. With the new kit, SAP customers can integrate SAP NetWeaver and Visual Studio .NET 2003. The PDK for .NET enables SAP customers to build content for the SAP Enterprise Portal, the portal component of SAP NetWeaver, using any of the supported development languages, including Microsoft Visual C# and Microsoft Visual Basic .NET. Developers can build the user interface of this interactive business content using any combination of the user interface controls from SAP for .NET and NetWeaver. Many SAP customers have standardized on Microsoft infrastructure and development tools for various parts of their businesses, and have been looking for more compatibility between SAP and Microsoft products. This allows those businesses to utilize their Microsoft Visual Studio skills for their SAP applications. At a higher level, this sort of SAP and Microsoft collaboration can't help but increase the interoperability of Microsoft and SAP tools and infrastructure in many other areas over the long term. For details, visit http://www.SAP.com.

New SAP Business One 2004 Adds Integration with Microsoft Excel

SAP AG has announced their new version of SAP Business One that leverages Microsoft Excel. The new XL reporter makes SAP Business One information immediately available in Microsoft Excel, eliminating the export and reformating of data. The technology was acquired through SAP's acquisition of iLytix Systems AS, a privately held software company based in Oslo, Norway. Terms of the deal were not disclosed. Business One now has improved MRP, and financials, and seamless integration with Microsoft Outlook. SAP Business One is a business management solution for small and midsize organizations. For details, visit http://www.SAP.com.

Agilent Technologies Names William Sullivan as President and CEO; Ned Barnholt to Retire

Agilent Technologies Inc. has announced that its board of directors has elected William P. (Bill) Sullivan as the company's next president and chief executive officer, effective March 1, 2005. Sullivan, 55, currently Agilent's
executive vice president and chief operating officer, succeeds Edward W. (Ned) Barnholt, who has announced his retirement as chairman, president and CEO of the company he helped launch following its spin-off from Hewlett-Packard in 1999. Barnholt, 61, had previously been an executive vice president of HP and the general manager of its measurement organization that incorporated all of Agilent's business groups. James G. Cullen, 62, who has served on Agilent's board of directors since 2000, will assume the position of non-executive chairman upon Barnholt's retirement in March. At that time, Sullivan will join the board. Barnholt will stay on as chairman emeritus as long as needed to ensure a smooth transition. In addition to his current responsibilities as executive vice president and COO of Agilent, Sullivan has had overall responsibility for the Electronic Products and Solutions Group (EPSG), Agilent's largest business group. He has been instrumental in returning this business to
financial health and in helping to lead the company's operational transformation. Sullivan was formerly senior vice president and general manager of Agilent's Semiconductor Products Group. He joined Hewlett-Packard in 1976, and during the course of his career developed considerable expertise in telecommunications, data communications,
computers and semiconductors. Sullivan, who was born in Yakima, Wash., received a Bachelor of Science degree from the University of California at Davis. For details, visit http://www.agilent.com.

ATL Welcomes LIMS Expert Michael Kelly as Director of Product Development

Accelerated Technology Laboratories, Inc. (ATL), a leading provider of LIMS, has announced the addition of Michael Kelly as Director of Product Development. Mr. Kelly is an accomplished, solution focused manager with over 16 years of experience in the LIMS industry with a strong focus on product design and development, deployment, installation and n-tier application development. Previously, Mr. Kelly served as Director of Technical Development at PerkinElmer Labworks, where he managed LIMS design and development for successful deployment of the firms LIMS solution. Mr. Kelly’s primary focus at ATL will be to guide product development strategies for new product releases which can be previewed at Pittcon 2005. For details, visit http://www.atlab.com.

Former HHS Official Says FDA's Inherent Flaws Remain Unaddressed

The FDA's inability to evolve and keep pace with the rapidly advancing pharmaceutical industry has left it with a wide array of problems, particularly on the drug safety front, asserts Eve Slater, former assistant secretary for health at HHS. "[The FDA's] progress since the passage of the Prescription Drug User Fee Act [in 1992] has been insufficient and the [agency] must evolve beyond satisfying the appetite of industry for faster approval of drugs," wrote Slater in an article published in The New England Journal of Medicine. "The FDA must strengthen its postmarketing safety surveillance and its oversight of the advertising and promotion of drugs. It must continually develop and sustain its capability in emerging areas of science. Perhaps most important, its expertise must be brought to bear in the control of surging drug costs," Slater wrote. Slater said the issue of postmarketing surveillance has never been more important in light of several recent drug safety controversies, such as Merck's recall of Vioxx (rofecoxib) in September 2004 and the FDA's health advisory for naproxen in December 2004. The FDA's current mechanisms for reporting and reviewing postmarketing data are "fraught with opportunities for human error," said Slater, who noted that the FDA lacks a system in which adverse event reports can be managed in an organized and timely fashion. To view an abstract of Slater's article, visit http://content.nejm.org/cgi/content/short/352/3/293.

Final Rule on Records to Protect Food Supply

The FDA has finalized regulations that will allow the agency to track foods implicated in emergencies such as intentional contamination. The regulations require food manufacturers and other food handlers to maintain records that identify the immediate previous source of all food received and the immediate recipient of all food released. The recordkeeping requirement is the fourth final regulation designed to increase the security of the U.S. food supply issued under the authority of 2002 bioterrorism legislation. This final FDA ruling on records and record keeping requires a minimum amount of information to identify the upstream source and down stream receiving firm. The manufacturing record must include information that is reasonably available to identify the specific source of each ingredient that was used to make every lot of finished product. The records can be in any format and must be available within 24 hours of receiving an FDA request. For details, visit http://www.fda.


	What's New - January to February 2005 The following is a wrap-up of news of interest during the months of January to February 2005