LIMSource Industry News - What's New - November to December 2003

• Autoscribe to Unveil New Matrix LIMS Software at Pittcon
• AAC Infotray AG Announces New Limsophy Solution
• Accelerated Technology Laboratories Announces Sample Master Integration with the EPA SEDD Format
• ABB Delivers Industrial IT-Solutions to Eastern Province Cement Company in Saudi Arabia
• TraxStar Defines Road Map for Global Test Lab Management
• Bio-Rad Receives Frost & Sullivan's "ADME/Tox Informatics Product Differentiation Innovation" Award
• Agilent Technologies, Bayer Business Services to Integrate Agilent Networked Data Systems with BBS COVIN Instruments Logistics Solution
• Agilent Technologies Returns to Profitability in Fourth Quarter 2003; Company Exceeds Fourth Quarter Expectations
• Agilent Technologies Announces Improved Method for Screening Genetically Modified Content in Food
• Scientific Software and Nanostream Sign Product Agreement for EZChrom Elite Chromatography Data System
• CSols and Novatek Announce New Alliance
• CSols Launches New Website for Laboratory Systems Integration and Instrument Interfacing
• DataApex Joins Labtronics' LimsLink Partnership Program
• Merck KGaA Implements Labtronics' LimsLinkCDS
• SAP CRM Announces New Utility-specific Functionality
• Cordys Systems and Vanenburg Company Merge
• SampleManager PIMS 2003 Introduced for Laboratory and Process Information Management
• Thermo Electron Acquires Laboratory Services Provider LMSi
• LabVantage Solutions and Scientific Software Announce Strategic Relationship
• Applied Biosystems Introduces GeneMapper ID Software v3.1
• Applied Biosystems and BergenShaw International Introduce Process Optimization Software for High-Throughput, Life Science Research
• AstraZeneca Purchases Galileo LIMS In Vitro Technology Application from InnaPhase Corporation
• InnaPhase Corporation Named One of the Delaware Valley's Fastest Growing Technology Companies in the Deloitte Technology Fast 50 Program
• New Siemens Operator Station & Electronic Signatures
• ABB Awarded Contract to Equip Eight Holcim Group Cement Works in Belgium and France with a LIMS
• Actemium and Werum Partner on Process Automation
• Waters Successfully Completes Pharmaceutical Industry PDA Audit and Joins Audit Repository Center
• TraxStar Introduces Global Test Lab Management Solution
• Agilent Technologies Introduces Flexible Software Solutions for Preparative HPLC
• HP and SAP Deepen Support of Large Enterprises
• Ariadne Genomics Introduces PathwayAssist 2.0
• FDA Issues Revised Electronic Format Guidance
• ARC Advisory Group Predicts Total Automation Market for Discrete Industries to Exceed $30 Billion
• China and India Provide Growth in Worldwide Chemical Investments According to ARC Advisory Group Study
• ARC Report Highlights Untapped Potential for LIMS Market

Autoscribe to Unveil New Matrix LIMS Software at Pittcon

Leading software systems developer, Autoscribe will be unveiling 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 is 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.

AAC Infotray AG Announces New Limsophy Solution

AAC Infotray has announced the release of their Limsophy (also known as @Limsophy) solution, which is designed for Windows xx. Oracle, MS-SQL-Server or open source databases such as Firebird are also supported. Limsophy fully supports the FDA guideline CFR 21 Part 11 and is GLP-compliant. It provides unlimited multi-language support and uses a modular structure to make it adaptable to any process. In order to be adaptable to any type of lab, regardless of the uniqueness of the particular lab’s processes, Limsophy introduces a concept entitled "Golden Medium", which is a compromise between standard LIMS and custom solutions. This concept uses "parameterization to optimize the balance between cost and strategy. The technical basis for "Golden Medium" is a software architecture, which provides features for standardization, flexibility and parameterization. Limsophy provides standard modules, features and functions, which are combined and adapted according to the customers need, thus delivering an integrated, adaptable solution. For details, visit http://www.infotray.ch.

Accelerated Technology Laboratories Announces Sample Master Integration with the EPA SEDD Format

Accelerated Technology Laboratories Inc. (ATL) has announced integration of Sample Master LIMS with the new EPA SEDD format. ATL, Inc. was one of the first LIMS vendors to commercialize Microsoft Windows-based LIMS, now offers LIMS with Microsoft MSDE, SQL Server and Oracle database engines. SEDD (Staged Electronic Data Deliverable) is a tool developed by the USEPA to create EDD's (Electronic Data Deliverables) in a generic format making it easier to share data between entities (i.e. the laboratory and the customer). ATL developed the Sample Master SEDD Output feature in its on-going effort to meet the needs of its clients. The Sample Master SEDD Output feature creates EDDs especially for environmental laboratories that are seeking a way of automatically creating EDD outputs without spending significant resources creating them. For details, visit http://www.atlab.com.

ABB Delivers Industrial IT-Solutions to Eastern Province Cement Company in Saudi Arabia

ABB, the global power and automation technology group, has been awarded a contract by the consortium leader Polysius AG of Germany for the new clinker production line being built for the Eastern Province Cement Company in Saudi Arabia. ABB has been involved in the planning, construction and commissioning of EPCC since the beginning of the company in 1982. The order was won, among other things, due to the excellent and longstanding relationship with EPCC, the success of previous deliveries, customer satisfaction with the delivered systems and equipment as well as the excellent service capabilities provided by ABB in the past. Polysius AG was awarded the complete contract in June 2003. Installation is scheduled to begin in January 2005 and commissioning in July 2005. Commercial operation of the new production line is planned to start by end of 2005. The scope of the ABB deliveries encompasses medium and low voltage distribution equipment, Drive IT variable speed drives Type ACS600 with low and medium voltage motors, Control IT process controllers and Operate IT human interface portals, electrical infrastructure as well as the interfacing and interconnection to the various systems and equipment of the existing plant. Erection, erection supervision, commissioning and customer training is also included within the ABB scope. The Eastern Province Cement Company is located at Khursaniyah on the coast of the Arabian Gulf close to the oil fields. The production capacity will be increased by 3500 tons to 10,500 tons per day when the new clinker production line No.3 comes on stream. For details, visit http://www.abb.com/cement.

TraxStar Defines Road Map for Global Test Lab Management

TraxStar has announced a blueprint for managing test labs that focuses on centralized management of multiple labs, at one site or spread around the globe using QATrax. The company states that there is increasing attention on the impact of test lab efficiency on the speed to market. Three trends are combining to create "the perfect storm" to threaten the effectiveness of test labs: manufacturing's expansion to low wage countries; expanding global markets for products ; and, shorter product cycles. The result is increased pressure on efficient design and validation, reliability and certification testing. This confluence of trends is occurring in a backdrop of limited test lab resources. TraxStar's road map for managing test labs with QATrax focuses on increasing visibility over the workflow using management dashboards to easily manage projects that span labs, and automating the complex scheduling and rescheduling of tests, workstations, engineers and technicians. For details, visit http://www.traxstar.com.

Bio-Rad Receives Frost & Sullivan's "ADME/Tox Informatics Product Differentiation Innovation" Award

Bio-Rad Laboratories, Inc. has received Frost & Sullivan's ADME/Tox Informatics Product Differentiation Innovation Award. This award is presented annually to one company that demonstrates the ability to produce the most innovative products in this category. Frost & Sullivan selects the award recipient based on market participant interviews, end-user surveys, and extensive secondary research. Gregory M. Banik, Ph.D, General Manager of Bio-Rad's Informatics Division remarked, "This award distinguishes KnowItAll's ADME/Tox environment from other systems on the market and speaks to the excellence of our ADME/Tox Informatics product line as a whole. Specifically, it recognizes the contributions made by our collaborators at ComGenex/CompuDrug International, ChemSilico LLC, and Syracuse Research Corporation, whose outstanding development teams have produced many of the cutting-edge tools that help make KnowItAll a complete in silico ADME/Tox solution for the drug discovery community." Bio-Rad's award-winning KnowItAll Informatics System offers a complete and fully integrated software environment for ADME/Tox prediction, including tools for structure drawing, database management, and customized reporting. For details, visit http://www.informatics.bio-rad.com.

Agilent Technologies, Bayer Business Services to Integrate Agilent Networked Data Systems with BBS COVIN Instruments Logistics Solution

Agilent Technologies Inc. and Bayer Business Services have announced they will develop and market the integration of BBS's COVIN Instruments logistics solution and Agilent's networked data systems, including Agilent Cerity NDS for Pharmaceutical Quality Assurance/Quality Control (QA/QC) and Agilent ChemStation. The integration optimizes the pharmaceutical manufacturing and QA/QC workflow by providing an online link between the SAP R/3 quality management systems, chromatographic data systems and analytical devices. Users can now transfer information between the different systems directly instead of manually re-entering data. This agreement is expected to benefit analytical laboratories in a wide range of industries, specifically those that must comply with GxP, FDA 21 CFR Part 11 and related regulations. The integration of the two companies' solutions is facilitated by the open-systems architecture of Agilent's networked data systems, which can seamlessly integrate with enterprise IT infrastructures. BBS's COVIN Instruments bridges the gap between the mySAP Product Lifecycle Management Quality Management (PLM QM) solution and the laboratory instrumentation level. The company claims that COVIN Instruments eliminates the need for a separate laboratory information and management system (LIMS) by enabling mySAP PLM QM to provide full LIMS functionality. Using an SAP-certified interface to QM-IDI, COVIN Instruments is designed to provide a work list of inspections to a client, depending on analytical method and instrumentation requirements. Raw quality-inspection data is collected from a wide range of instruments, managed, and archived in compliance with FDA 21 CFR Part 11 and ISO quality standards. After optional validation, measured and calculated end results are sent back to mySAP PLM QM to trigger subsequent actions in the logistic chain. Agilent Cerity NDS for Pharmaceutical QA/QC is designed to meet the specific requirements of QA/QC labs in the pharmaceutical industry. It provides centralized management of chromatography data for labs from one
instrument to several hundred instruments and many users. It reduces a lab's operating and validation costs by accommodating the laboratory's workflow and by facilitating compliance with FDA 21 CFR Part 11 and
quality standards. For details, visit http://www.bayerbbs.com or http://www.agilent.com.

Agilent Technologies Returns to Profitability in Fourth Quarter 2003; Company Exceeds Fourth Quarter Expectations

Agilent Technologies Inc. has reported orders of $1.73 billion and revenue of $1.68 billion for the fiscal fourth quarter ended Oct. 31, 2003. During the quarter, the company reported GAAP net earnings of $13 million, or $0.03 per diluted share. This compares to a GAAP loss of $236 million, or $0.51 per share, in last year’s fourth quarter. Excluding $58 million of net restructuring charges and intangibles amortization, Agilent reported operating net income of $71 million, or $0.15 per share, versus a loss on a comparable basis of $2 million, or $0.00 per share, one year ago. “We had a very good finish to a very tough year,” said Ned Barnholt, Agilent chairman, president and chief executive officer. “Orders, revenues and earnings all came in above expectations. We met our commitment to achieve an operating breakeven cost structure of $1.45 billion and earned an attractive profit on the additional revenue we realized. We also met our commitment to generate positive free cash flow." The company ended the quarter with about $1.6 billion in cash and equivalents, up $177 million from the prior quarter. Despite $82 million of cash restructuring costs, operations generated free cash flow of about $170 million. In the fourth quarter, inventories improved to below 100 days on hand for the first time in Agilent's history. Capital spending of $57 million was $21 million below the level of depreciation. During the fourth quarter, Agilent saw evidence of stronger economic activity reflected in several of its markets. Semiconductor Products orders were up 36 percent from one year ago to the highest level since early 2001. Automated Test segment orders were higher for the third consecutive quarter, reaching the highest level in three years. Life Sciences and Chemical Analysis orders were at record levels, 8 percent ahead of one year earlier. Activity in the Test and Measurement segment was somewhat weaker than the prior year because of continued softness in wireline telecom markets. Overall, the company’s book-to-bill ratio was 1.03 compared to 0.98 in the prior quarter and 0.86 one year ago. Looking ahead, Barnholt said, “About 40 percent of Agilent’s revenues today are tied to consumer electronics. As such, the first quarter of fiscal 2004 will be seasonally weaker. But, we believe Agilent now has the cost structure as well as the innovative new products to take full advantage of the recovery in our markets.” For the first quarter, the company anticipates revenues in the range of $1.55 billion to $1.65 billion. Earnings before restructuring and amortization charges are expected to be in a range of $0.05 to $0.15 per share. For details, visit http://www.agilent.com.

Agilent Technologies Announces Improved Method for Screening Genetically Modified Content in Food

Agilent Technologies Inc. has announced an efficient, high-resolution method for detecting genetically modified (GM) content in food products. Researchers can use this method to rapidly screen samples before running the expensive and time-consuming analyses required to quantify GM content. There remains an ongoing debate about how food products that contain GM ingredients should be regulated, labeled and detected. Consumer concern about the use of GM organisms in food is high, particularly in Europe. DNA analysis is currently the most effective analytical approach for detecting GM ingredients in a wide range of food, from raw to highly processed. Real-time PCR (polymerase chain reaction) is the most widely accepted method for quantifying GM DNA. However, this method is expensive (up to $300 for a single analysis) and time consuming, requiring assay calibration for each sample lot and multiple replicates of each unknown compound. Most laboratories, therefore, conduct a generic GM content screen of samples before performing a complete quantitative analysis. The traditional method for testing these samples uses gel electrophoresis, which is clumsy and less than optimal for screening multiplex PCR products. When gel electrophoresis is optimized for rapid screening, only a marginal separation of multiple analytes is achieved. For GM screening, the Agilent 2100 bioanalyzer provides several advantages over gel electrophoresis in terms of resolution, convenience and speed of analysis. In this new method, Agilent scientists used an Agilent 2100 bioanalyzer with DNA 500 LabChip to resolve and detect multiplex PCR products corresponding to GM DNA segments in corn and soybeans. The multiplex products were produced using Promega's Biosmart Allin 1.0 GMO Screening System, a nested multiplex PCR assay. Resolution and sensitivity were sufficient to identify all the multiplex PCR targets and to differentiate these targets from PCR artifacts.Further information is available by requesting Agilent application note "Nested Multiplex Polymerase Chain Reaction for the Determination of DNA from Genetically Modified Corn and Soybeans Using the Agilent 2100 Bioanalyzer," Agilent publication 5989-0124EN. This note is available without charge from any Agilent sales office or on Agilent's Web site at http://www.agilent.com/chem.

Scientific Software and Nanostream Sign Product Agreement for EZChrom Elite Chromatography Data System

Scientific Software, Inc.and Nanostream, Inc., a provider of high throughput microfluidic analytical systems to companies in drug discovery and development, have signed a product agreement to deliver high quality chromatography data system technology to end users. Based on this agreement, Nanostream will offer Scientific Software's chromatography data system, EZChrom Elite Elite, for use with its premier micro parallel liquid chromatography product (mPLC), the Veloce system. EZChrom Elite has been deployed in laboratories throughout the world that are involved in HPLC, GC and related chromatography applications in pharmaceutical, petrochemical, biomedical, chemical, environmental and testing laboratories. Nanostream formed its business around increasing the throughput of well-established high performance liquid chromatography (HPLC) techniques for companies involved in drug discovery and development. Nanostream's initial product, the Veloce system, delivers an increase in sample analysis capacity by enabling 24 simultaneous separations using one of Nanostream's Brio cartridges. This system is designed for scientists who demand higher analytical throughput and need access to critical information sooner to make timely research decisions. The Veloce system began shipping in June of 2003 and will be launched at the upcoming LabAutomation 2004 conference in San Jose from February 1-5, 2004. As the Veloce system continues to garner interest at companies across the pharmaceutical industry, Nanostream is partnering with Scientific Software to offer increased chromatography data analysis capabilities to its customers. For details, visit http://www.scisw.com or http://www.nanostream.com.

CSols and Novatek Announce New Alliance

CSols and Novatek have announced that they are partnering to market and sell products and services encompassing CSols Links for LIMS. This new alliance benefits analytical laboratories by providing advanced solutions that streamline data acquisition and management, and enable integration of networked laboratory data systems which includes chromatography data systems (CDS), instruments and LIMS. Instrument-CDS-LIMS integration enables improved regulatory compliance and productivity in the drug discovery, development and manufacturing process. Links for LIMS software provides a seamless, bi-directional interface between networked data systems and any LIMS by using plug-in drivers for all major commercial LIMS. This allows users of networked data systems to integrate their laboratory instruments and chromatography data with their enterprises’ LIMS in accordance with common regulatory standards such as GLP, GMP or the US Food and Drug Administration’s ruling on electronic records and signatures (21 CFR Part 11). Work lists can be uploaded from the LIMS to the CDS. The software can automatically build sequences and report results to LIMS, and can also automate most manual data manipulation and review activities. The software is scaleable from a single instrument to the largest enterprise systems. CSols’ Links for LIMS can also integrate other (non-CDS) instruments with LIMS. Novatek offers 21 CFR Part 11 compliant solutions for the entire product life cycle of healthcare quality operations, providing solutions for manufacturing, packaging, and quality assurance and control. This comprehensive capability is delivered by Advanced Quality Nova-LIMS at the core, and complementary applications that serve specialized needs. For details, visit http://www.csols.com or http://www.ntint.com.

CSols Launches New Website for Laboratory Systems Integration and Instrument Interfacing

CSols has launched a totally redesigned website for their Laboratory Systems Integration services and Instrument Interfacing products that provides users with a comprehensive overview of integrating laboratory systems and instruments including current and previous issues, press releases, 21CFR11 links, and details on CSols professional services. Visitors to the site also will be provided with the details of the importance of a quality plan when embarking on instrument interfacing projects in regulated industries. Founded in 1988 (initially as Contemporary Solutions), the company provides cost-effective, easy to implement and easy to use, compliant solutions with dependable support. CSols Laboratory Systems Integration products are fully configurable and require no end-user programming or scripting to deploy. For details, visit http://www.csols.com.

DataApex Joins Labtronics' LimsLink Partnership Program

DataApex has joined Labtronics' LimsLink Partnership Program. As a Gold Level member of the Partnership Program, DataApex will provide LimsLinkCDS as a fixed price, LIMS interfacing solution that can be implemented along with their Clarity Chromatography software. Clarity users will now enjoy having full integration between their chromatography systems and their LIMS. A key component of the Gold Level Partnership, is the co-operative development between Labtronics and DataApex of a solution that significantly reduces the time and cost of implementing the interface, while providing the end users with a total data management solution. Using LimsLinkCDS, worklists can be automatically acquired from the LIMS and passed directly to Clarity, eliminating the need for manual input of sample information. Data from Clarity can be transferred directly to any LIMS or held for review by the analyst before being committed to the LIMS. Electronic signatures, password protection and a complete audit trail provide the level of security and accountability required for achieving 21 CFR Part 11 compliance. For details, visit http://www.dataapex.com or http://www.labtronics.com.

Merck KGaA Implements Labtronics' LimsLinkCDS

Merck KGaA of Darmstadt, Germany, is now transparently transferring sample information and data between their HP LIMS and over 80 chromatography instruments running the EZChrom Elite Chromatography Data System, thanks to a new LimsLinkCDS interface implemented recently by Labtronics B.V. Using LimsLinkCDS, LIMS worklists can be exported directly to EZChrom Elite as formatted sequences. At runtime the analyst simply loads the sequence into EZChrom Elite and is ready to run the samples. A new menu option has been added to EZChrom Elite that automates reporting to LIMS. Once this item is selected, LimsLinkCDS automatically retrieves results from the CDS database, formats them for HP LIMS and transfers them directly into the LIMS without creating any intermediary files. Merck KGaA's Ethical Pharmaceuticals Division has implemented LimsLinkCDS as
a "black box" solution. Analysts transfer sample information and data between their LIMS and CDS without having to interact with the interfacing application. All processes are started from either HP LIMS or EZChrom Elite and are carried out in the background. For details, visit http://www.labtronics.com.

SAP CRM Announces New Utility-specific Functionality

SAP has announced utility-specific functionality with the latest version of mySAP Customer Relationship Management (mySAP CRM) to meet the unique demands of utility companies. mySAP CRM supports cross-functional business processes to streamline customer service and optimize energy data with billing and revenue management systems for residential, commercial, and industrial customers. Enhanced features of the solution include closed-loop sales processes for commercial and industrial customers, sales management for residential customers, campaign management and an account manager portal. The new interaction center capabilities in mySAP CRM offer expanded communications channels, including computer telephony integration, e-mail, text chat and Web communication, to support expanded marketing activities, better customer service, and collaboration between service providers. For details, visit http://www.sap.com.

Cordys Systems and Vanenburg Company Merge

Cordys Systems (Cordys), a leading provider of a Web Services platform on which enterprises can develop, deploy and support mission critical applications, and Vanenburg Company, a leading provider of Web Services solutions that empower enterprises to easily manage sales, quality, production and customer service processes, have merged their global operations.Vananburg acquired Guardess BV, the developer of QM LIMS, in late 2002. The newly combined entity will operate under the Cordys brand. With more than 250 customers, 550 employees, 400 engineers in a state-of-the-art software factory and competency center in India, a global presence and strong financial backing, Cordys is positioned to provide Global 2000 companies and key Independent Software Vendors a comprehensive Web Services offering. For details, visit http://www.cordys.com.

SampleManager PIMS 2003 Introduced for Laboratory and Process Information Management

Thermo Electron Corporation has announced the launch of a new software integration solution for real-time management of laboratory and process information. Thermo’s flagship SampleManager LIMS (Laboratory Information Management System) has been integrated with leading PIMS (Process Information Management Systems) to enable the timely delivery of quality data for plant- and enterprise-wide monitoring and analysis purposes, and to ensure process integrity. Called SampleManager PIMS 2003, the launch release supports integration with OSIsoft PI (Plant Information) System, Honeywell Uniformance PHD, and Yokogawa Exaquantum. Thermo also provides a solution for integrating SampleManager LIMS with AspenTech’s InfoPlus.21 PIMS. PIMS products provide vital interactive control of production processes. Once a sample has been logged and analyzed for a pre-defined test in SampleManager, results can be sent to the PIMS in a secure manner. This enables a plant engineer or operator to analyze and track data trends, as well as make decisions about data from the different locations throughout the production process. These results are critical in optimizing processes and in highlighting potential problem areas requiring attention; for example, poor product quality results from the laboratory may necessitate changes to a reactor’s operating temperature. Information can also be sent directly from PIMS to SampleManager, eliminating the need for manually entering recorded information and any associated errors. This more tightly controlled process reduces product loss and improves productivity. For details, visit http://www.thermo.com/informatics.

Thermo Electron Acquires Laboratory Services Provider LMSi

Thermo Electron Corporation, a leading global supplier of laboratory instruments and services, has announced that it has acquired Laboratory Management Systems, Inc. (LMSi) of New Castle, Delaware. LMSi is a supplier of regulatory instrument and consulting services to the pharmaceutical and related industries, and generated revenues of $11 million during its 2003 fiscal year. In its nine-year history, LMSi has been ranked three times on Inc. magazine's annual "Inc. 500" list of America's fastest-growing private companies. LMSi specializes in performing instrument and computer systems validation, metrology, and certification, as well as a range of associated consulting services. The company has developed a broad portfolio of analytical instrument validation protocols and operating procedures that enable laboratories to comply with U.S. Food and Drug Administration requirements. "This acquisition is an important step in our strategy to offer customers comprehensive laboratory solutions that include full product support, for almost any instrument, anywhere," said Marijn E. Dekkers, president and chief executive officer of Thermo Electron. "Adding LMSi's regulatory and compliance expertise to our global laboratory service network will allow us to be a regulatory validation and consulting partner to customers who face increasing productivity, quality, and regulatory challenges." For details, visit http://www.thermo.com/informatics.

LabVantage Solutions and Scientific Software Announce Strategic Relationship

LabVantage Solutions, Inc., a leading provider of Enterprise LIMS and Life Sciences LIMS solutions, and Scientific Software Inc., a world leader in providing software solutions to the scientific community, have announced that they have entered into a broad strategic relationship that will provide customers using Scientific Software's CyberLAB Knowledge Engineering System (KES), and LabVantage's Sapphire LIMS, with a completely integrated software solution between an enterprise LIMS solution, and a long-term data archival and retrieval solution. The broad strategic agreement has many key elements that provide assurance that this multi-vendor solution is sustainable and supportable in the future. Key aspects of the agreement include: Development organizations will work closely to ensure software compatibility and to enhance the customer experience; Sales and Marketing organizations will work closely to educate and communicate joint capabilities; Quality and testing organizations will work closely to ensure that the integration efforts function as designed, and company independence does not adversely affect the customer experience. For details, visit http://www.labvantage.com or http://www.scisw.com.

Applied Biosystems Introduces GeneMapper ID Software v3.1

Applied Biosystems has introduced their new GeneMapper ID Software v3.1 which combines features from GeneScan and Genotyper software in a single convenient analysis package. An integral component of Applied Biosystems complete system of reagents, instruments, software, and support for human identity testing, GeneMapper ID Software v3.1 is designed specifically for forensic casework, establishing convicted offender and population databases, performing parentage testing, tracking specimens, and identifying missing persons, military personnel, and mass disaster remains. GeneMapper ID Software v3.1 provides accurate and reliable allele calls and a streamlined, user-friendly interface. It has also been verified for use on ABI PRISM genetic analysis instruments, validated for use with human identification applications. Process quality values (PQVs) measure the overall quality of sample genotypes and produce graphical color-coded “flags” that indicate a potential cause of ambiguous genotype calls. In addition, built-in automated concordance checks for controls and markers common to various AmpFLSTR PCR amplification kits, measure data integrity before results are exported in a CODIS-compatible format.For detais, visit http://www.appliedbiosystems.com.

Applied Biosystems and BergenShaw International Introduce Process Optimization Software for High-Throughput, Life Science Research

Applied Biosystems and BergenShaw International have announced the release of Focus Research?, a process optimization software tool for life science laboratories. The software automatically analyzes the performance of factors associated with laboratory processes and identifies weaknesses or failures caused by expired reagents, instruments that require service, or operators who require additional training. Developed by BergenShaw International, Focus Research? is the only such software tool available for the life science market. Applied Biosystems is the exclusive distributor of Focus Research? and will offer the product through its Informatics Software and Services for Discovery business. Focus Research? is designed for large core, pharmaceutical, and biotech laboratories engaged in genotyping, gene expression, sequencing, and proteomics applications. The software is expected to add value to LIMS data by assigning a performance value to each variable of data in a high throughput research environment, thus eliminating the need to stop an experiment to identify a failure in the process. Additionally, the software can automatically monitor laboratory processes, and sends reports to laboratory personnel on a timed basis. For details, visit http://info.appliedbiosystems.com/consult.

AstraZeneca Purchases Galileo LIMS In Vitro Technology Application from InnaPhase Corporation

InnaPhase Corporation, a leading provider of LIMS solutions for the life sciences, has announced that AstraZeneca has purchased the latest in vitro LIMS technology, Galileo LIMS, for in their Alderley Park Research and Development Center based in the United Kingdom. The Galileo LIMS solution is a comprehensive, GLP and 21 CFR Part 11 compliant, procedure-based LIMS for the design of in vitro studies, sample bioanalysis, and data calculation for permeability, metabolic stability, enzyme inhibition (IC(50) and K(i)), mechanism-based inactivation, and protein binding experiments. In vitro experiments in Galileo are defined using an integrated task manager, with built-in analytical instrument interfacing, calibration curve regression, a graphics gallery for data review and reporting, and includes an integrated document management system. Galileo is asecurity-controlled, audit-trailed environment using an Oracle 9i database. "One of AstraZeneca's key priorities is continuous improvement in our overall productivity and efficiency to enable us to meet our target of delivering new, medically important and commercially successful medicines to market every year," said Dave Sweetmore, Business Project Manager. "We have been impressed with the use of InnaPhase's Watson LIMS solution in our bioanalytical laboratory and we are certain that Galileo will produce the same outstanding results for our in vitro studies." "In vitro data is increasingly being scrutinized because of its importance in obtaining BCS biowaivers as justification for not conducting clinical bioequivalence studies," said Dr. Jo Webber, CEO and President of InnaPhase Corporation. "Since the in vitro data is being submitted to the FDA, the ability to conduct in vitro experiments in a GLP compliant manner is critical and we are pleased that AstraZeneca has chosen Galileo, a `must have' solution for in vitro studies." AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $17.8 billion and leading positions in sales of gastrointestinal, oncology, anesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products. For details, visit http://www.innaphase.com.

InnaPhase Corporation Named One of the Delaware Valley's Fastest Growing Technology Companies in the Deloitte Technology Fast 50 Program

InnaPhase Corporation has been named to Deloitte's prestigious Technology Fast 50 Program for the Delaware Valley, a ranking of the 50 fastest growing technology companies in the area by Deloitte, one of the nation's leading professional services firms. Rankings are based on the percentage of growth in fiscal year revenues over five years, from 1998-2002. InnaPhase increased its revenues by 1,284 percent resulting in a sixth ranking overall in the Fast 50 for the Delaware Valley. To qualify for the Technology Fast 50, companies must have had operating revenues of at least $50,000 in 1998 and $1,000,000 in 2002, must be public or private companies headquartered in North America, and be a "technology company" defined as owning proprietary technology that contributes to a significant portion of the company's operating revenues (using other companies' technology in a unique way does not qualify); and/or devoting a significant proportion of revenues to research and development of technology. For details, visit http://www.deloitte.com/us or http://www.innaphase.com.

New Siemens Operator Station & Electronic Signatures

Siemens Energy & Automation has introduced the SIMATIC PCS 7/90 Operator Station to migrate Bailey systems to Siemens technology. With the new operator station, Bailey INFI 90 and NET 90 users can migrate to the SIMATIC PCS 7 process control system. The new operator station will replace existing Bailey operator consoles while maintaining installed controllers, I/O and field wiring. The SIMATIC PCS 7/90 Operator Station offers predefined faceplates and graphic symbols for interaction with Bailey block types, ensuring operators, engineering and maintenance personnel a consistent look and feel. The company has also announced the new electronic signature capabilities of SIMATIC BATCH that help users comply with the FDA requirements of 21 CFR Part 11, Electronic Records: Electronic Signatures. SIMATIC BATCH is the standard batch management software package used with the SIMATIC PCS 7 process control system. It automatically records all operator actions, electronic signatures, and events associated with a batch. The new electronic signature capability allows users the flexibility to define multiple signatures to each operator action or batch event, as well as the specific signing order. SIMATIC BATCH electronic signatures leverage security features, including password aging and user ID uniqueness. For details, visit http://www.siemens.com.

ABB Awarded Contract to Equip Eight Holcim Group Cement Works in Belgium and France with a LIMS

ABB, a leading power and automation technology group, has a global frame agreement with Holcim for technical information systems (TIS). TIS is a common platform for laboratory information systems (LIMS) and production management systems (PIMS) and can be implemented in various steps. The commissioning of the LIMS installations in eight Holcim cement works in France and Belgium has already been successfully completed. The contract was awarded to ABB in June 2001 and installation and commissioning took place over a period between September 2001 and December 2002. The scope of supply and services included the software application LIMS based on Windows and Oracle databases, computer hardware, engineering, training, project management and commissioning as well as the interfaces to the laboratory equipment. A special challenge was the integration of the many and varied types of laboratory equipment as well as the transfer and incorporation of the historical data from the existing laboratory system. The fact that data will be exchanged in future between the various works and that the system can be expanded with PIMS to TIS is very significant for the customer as well as for ABB. This modular system is part of ABB's AdviceIT application suite and can be extended with new interfaces as and when required. Extensions have already been ordered in the meantime. For details, visit http://www.abb.com.

Actemium and Werum Partner on Process Automation

Actemium and German-based Werum Software & Systems will cooperate on integrated process automation solutions for pharma and biotech companies on the French market. Actemium, the brand of the French group VINCI Energies, provides process solutions adapted to customer's requirements to optimize their plants and process flows; from sensors and automation up to ERP systems. Werum is an international provider of Manufacturing Execution Systems (MES) for the pharmaceutical industry. The customers of the two companies will benefit from integrated process automation solutions. Werum's PAS-X MES suite coordinates, optimizes and controls all workflows within manufacturing enabling a real paperless production. PAS-X ensures both vertical integration with the ERP level (e.g. SAP) and the field level as well as horizontal integration with the supply chain. Werum's PAS-LIMS solution is designed for pharmaceutical, food & beverage, and basic industrial applications. For details, visit http://www.werum.de.

Waters Successfully Completes Pharmaceutical Industry PDA Audit and Joins Audit Repository Center

Waters has successfully completed the PDA Pharmaceutical Industry Software Supplier Quality Audit. Conducted by independent, PDA-approved auditors. This evaluation allows Waters customers to meet the federal government requirements for companies that supply software solutions to the pharmaceutical industry. Following the PDA audit process, the auditors reviewed documented evidence of structural validation and assessed Waters compliance to the established Software Development Life Cycle (SDLC). The results of Waters audit are available through the Audit Repository Center (ARC), a global information sharing venue licensed by the PDA. The PDA, a non-profit international association for pharmaceutical sciences and technology, created a six-step process for audit execution that is outlined in its Technical Report #32. This technical report was written by the PDA Supplier Auditing and Qualification Task Group – comprised of pharmaceutical companies, suppliers, auditors and FDA members – in response to an FDA challenge to create a standard method to assess the structural integrity of acquired software. Pharmaceutical companies must demonstrate compliance with industry regulations, such as the Food and Drug Administration’s 21 CFT Part 211.86 and 21 CFR Part 11. It is both costly and time consuming to show compliance with the audit requirements. By making the results of Waters software audit available through ARC (www.auditcenter.com), Waters customers do not need to conduct their own on-site audits, saving significant time and money. Waters Corporation holds worldwide leading positions in three complementary analytical technologies - high performance liquid chromatography (HPLC), mass spectrometry (MS), and thermal analysis (TA). The company’s technologies – instruments, software, chemistries – and its related support services, enable scientists to derive key information about the composition of chemical mixtures and the thermal and mechanical properties of materials. For details, visit http://www.waters.com.

TraxStar Introduces Global Test Lab Management Solution

TraxStar has introduced a new global test lab management solution designed for management of many labs, at one site or spread around the globe with the new release of QATrax version 3.2. The new version provides efficiency and increased throughput resulting from the application of standard processes and procedures applied across all the labs in the global operation. High visibility is provided for resource usage, in a single lab and across groups of labs. Scheduling and re-scheduling tests across global operations benefits from the consistent application of workflow process and procedures. Using one database, users experience quick browser-like performance with native, full-featured Window functionality. QATrax 3.2 extends global functionality to encompass TraxStar's Global Approach Vision.TraxStar develops custom and off-the-shelf solutions (QATrax, StaffTrax, TempTrax and QCPro). TraxStar products are workflow automation solutions that improve a company's operating efficiencies. For details, visit http://www.traxstar.com.

Agilent Technologies Introduces Flexible Software Solutions for Preparative HPLC

Agilent Technologies Inc. has announced the availability of new software solutions for the Agilent 1100 Series high-performance liquid chromatography (HPLC) purification system. The new Agilent ChemStation software modules provide flexible functionality for preparative HPLC, enabling users to start with a basic solution and add modules for specific needs. The Agilent 1100 Series purification platform is widely used in the pharmaceutical industry for compound isolation and purification. It can be configured with a wide range of hardware modules including pumps, auto-injectors, fraction collectors and detectors to optimize recovery and purity for different sample quantities. The system's flexible approach to hardware has now been extended to software, with the following software modules available: Basic Purification Solution; Advanced Purification Solution; and, Walk-Up Purification Solution. Each solution also includes the Agilent ChemStation Data Browser, which provides remote data browsing and quick setup of purity reports. For details, visit http://www.agilent.com/chem/purification.

HP and SAP Deepen Support of Large Enterprises

Hewlett Packard and SAP AG have announced a memorandum of understanding aimed at deepening their collaboration to help large enterprises lower the total cost of IT operations. By combining the necessary toolsets and methodologies from the HP Adaptive Enterprise strategy and SAP’s adaptive business service strategy, they will work to allow more effective management of customers’ entire heterogeneous IT environments. Leveraging SAP’s business application and process management strengths and HP’s industry-leading infrastructure management solutions for heterogeneous environments, the companies intend to provide customers with a managed application environment. For details, visit http://www.hp.com or http://www.sap.com.

Ariadne Genomics Introduces PathwayAssist 2.0

Ariadne Genomics has introduced PathwayAssist 2.0, an intuitive desktop software featuring: pathway visualization and analysis, and automated data extraction from scientific texts and MEDLINE abstracts. A database of more than 200,000 events of regulation, interaction and modification between 15,000 proteins, cell processes and small molecules is included. The PathwayAssist price is $2,250 for academic, and $3,000 for corporate users. Ariadne Genomics, a privately held bioinformatics company, is a technology leader in development of proprietary natural language processing (NLP) and statistical algorithms designed to functionally interpret novel geneticinformation. The software is available for a free 20 day trial at http://www.ariadnegenomics.com/downloads.

FDA Issues Revised Electronic Format Guidance

The FDA has issued a revised draft guidance on electronic submissions, detailing the formats, fonts and other electronic features the agency expects in any electronically formatted regulatory filing from drugmakers. In the draft, the FDA said all electronic documents should be submitted in portable document format (PDF), and that the submissions should include search capabilities so reviewers can find data quickly. For electronic data sets — large amounts of related scientific data – the FDA can support the SAS System XPORT Transport Format as well as extensible markup language (XML) and standard generalized markup language (SGML). Drugmakers should work with the FDA to determine the best data set format for their particular submissions, the agency said. The FDA noted in the draft guidance that all electronic submissions must adhere to 21 CFR Part 11, the rule dealing with electronic submissions and esignatures. The agency issued a final guidance on Part 11 in September 2003. For details, visit http://www.fda.gov.

ARC Advisory Group Predicts Total Automation Market for Discrete Industries to Exceed $30 Billion

After enjoying a period of solid economic growth, the global economy went into a tailspin in 2002 states ARC Advisory Group in a recent study. However, the overall future of automation products serving the discrete industries looks bright over a five-year period. The total automation business to worldwide discrete industries is expected to grow at a Compounded Annual Growth Rate (CAGR) of 6.1 percent over the next five years. The market is forecasted to be over $30 billion in 2007, according to a new ARC Advisory Group study. With a bottoming of the economy and changing user perspectives on automation and collaborative manufacturing, ARC anticipates the overall automation market growth will continue. “There are still many pockets of reliable growth in the discrete automation business. Industries such as building automation, electronics & semiconductor, automotive, and plastic machinery will continue to perform well,” according to Senior Analyst Himanshu Shah, the principal author of ARC’s “Total Automation Business for the Discrete Industries Worldwide Outlook.” Additional information on this study can be found at http://www.arcweb.com/res/tadww.

China and India Provide Growth in Worldwide Chemical Investments According to ARC Advisory Group Study

The worldwide market for plant-level expenditures in the chemical industry, which totaled more than $214 billion in 2003, will reach almost $241 billion by the end of 2008, expanding at a Cumulative Annual Growth Rate (CAGR) exceeding 2 percent, according to a new study by the ARC Advisory Group. "After experiencing disappointing results during 2002, the worldwide chemical industry continues to be plagued by overcapacity, weak demand, and declining prices, but opportunities are available,” according to Senior Analyst Dave Clayton, author of ARC’s Chemical Industry Plant-Level Expenditures Worldwide Outlook. "Capital spending trends and the health of the chemical industry is highly susceptible to both global and local economic influences,” Clayton says. “Although there is significant concern and consternation in the developed countries of Western Europe, North America, and Japan regarding the transfer of manufacturing to low labor cost countries, considerable opportunities are available for those companies that can take advantage of the dynamic growth now occurring in Asia, particularly in China and India.” Globalization is a key trend that will help shape capital expenditures in the chemical industry over the forecast period. Avid consumer demand for low cost products is forcing many companies to look offshore to lower production costs. Many chemical companies are expanding their presence in the developing regions of the world to take advantage of low-cost structures as well as growing demand for chemicals in these regions. China, with its low cost labor and rapidly improving manufacturing capability, has been a major beneficiary of the move offshore. India is also benefiting from the globalization of the chemical industry; even if the country’s economic growth has performed below expectations. Additional information on this study can be found at http://www.arcweb.com/res/chem.

ARC Report Highlights Untapped Potential for LIMS Market

According to a recent report from the ARC Advisory Group, manufacturers of all sizes across industry boundaries are recognizing that home grown systems may not be cost effective. The perception that commercial LIMS solutions require extensive customization is outdated. Manufacturers are displaying an increased willingness to implement moderately customized, out-of-the-box solutions to decrease their LIMS Total Cost of Ownership (TCO). For the full story, visit http://www.arcweb.com/Newsmag/auto/lims102303.asp.

What's New - November to December 2003 The following is a wrap-up of news of interest during the months of November to December 2003

What's New - November to December 2003
The following is a wrap-up of news of interest during the months of November to December 2003