LIMSource: What's New - July to August 2004

• Autoscribe Launches MatrixStability Express TK Solutions for Stability Studies
• Computing Solutions Releases LabSoft LIMS Micro for Microbiology Test Management
• LabPlus Technologies Spins off from Desert Moon Technologies
• STARLIMS Public Health Projects
• Agilent Technologies Gains Exclusive Rights to Sell SSI's CyberLAB Enterprise Content Management System
• Thermo Electron Discontinues eRecordManager
• NIBSC Implements MediData Systems' ItemTracker Sample Tracking Software
• Accelerated Technology Laboratories Partners with CoreTEC Systems & Solutions in Africa
• QATrax Increases Scheduling Productivity
• Labtronics Inc. Releases New Toolkit for Validating Instrument/LIMS Interfaces
• Bio-Rad Releases Thirteen New ADME/Tox Databases
• EISC Announces Scalability for R&R Suite
• AEC Software Announces Strategic Partnership with UK-Based Computers Unlimited
• ARC's New RFID Systems in the Manufacturing Supply Chain Study Released
• FDA Adopts New Standard for Submitting Clinical Trial Data
• FDA to Establish New Office of Oncology Drug Products
• FDA Should Scrap Part 11, Rely on Congress for eRecords Policy, PhRMA Says
• Risk Management Guidelines May Have Positive and Negative Effects
• FDA on Track to Approve More than 400 Generics in 2004
• NME Applications Expected to Exceed 2003 Total
• FDA Agenda to Focus on Label Changes, Export Rules for Rest of 2004
• Thermo Electron Releases SampleManager 2004 R2
• New MSC-LIMS Version 3.0 Lowers Total Cost of Ownership
• Autoscribe Announces New LimsLink Software
• AMO Selects Newton LIMS from InnaPhase for its QC Manufacturing Facility in Spain
• Group Logic Releases OEM-Only AppleTalk Protocol for Windows XP
• National Instruments and Agilent Technologies Extend Functionality, Flexibility of Analytical Instrumentation with LabVIEW
• Thermo Electron Introduces Web Seminar Series
• Agilent Technologies Announces Life Science Tool for Standardized Measurement of RNA Quality
• ABB Supplies Industrial IT Solution to Ras El Ma Cement Plant, Morocco
• ABB Optimizes Cement Processing for Cement Australia
• Labtronics' Nexxis CAL Connects Instrument Calibration with Everyday Analysis
• New Beckman Coulter Software for CEQ Genetic Analysis System Enables Data Management and Visualization
• Agilent Technologies Introduces Online Training for Gas Chromatography Instruments
• Gloria Metrick Honored by Independent Computer Consultants Association
• Bruker Daltonics Appoints Dr. Ian Sanders as Assistant Vice President for European Life-Science Sales
• Bruker Daltonics Appoints Hans Baum as Vice President of European Operations
• FDA Issues Three Guidances on Developing Medical Imaging Drugs
• FDA Timeline for New SPL Formatting Requirement Postponed
• Public Part 11 Meeting Cancelled, Some Confusion Remains

Autoscribe Launches MatrixStability Express TK Solutions for Stability Studies

Autoscribe has launched Matrix Stability Express TK, a new software package designed in conjunction with several
pharmaceutical companies to manage and report on protocol driven studies associated with stability or shelf-life testing. The protocol designer allows the entry and subsequent management of all study data. Furthermore, information is stored in one location for easy access by authorised users. Stability Express also manages storage room operations for quick and easy retrieval of samples and the cycling of conditions, where required. An inventory management capability ensures sufficient material is available for an entire study and prevents undue wastage through the excess storage of containers. As samples are taken from a store room, information is automatically registered onto the results system and the appropriate tests and limits allocated according to the protocol requirements. This saves significant operator time and raises the efficiency of stability testing exercises. Matrix Stability Express TK comes with a set of standard reports, together with a link to JMP statistical analysis software for calculating shelf life projections, accelerated shelf life and more. Audit trail generation and other features assist in the compliance with FDA regulatory requirements such as 21 CFR Part 11. Autoscribe is offering a choice of two validation service plans. The first is a set of tools that helps users validate the system using Windows-prepared documentation. The second is a ‘Full Validation Service’ that involves visits to the user site for the execution of validation scripts. For details, visit http://www.autoscribe.co.uk.

Computing Solutions Releases LabSoft LIMS Micro for Microbiology Test Management

Computing Solutions, Inc. (CSI) has released LabSoft LIMS Micro (Micro). This Add-In Module manages the
microbiology testing environment to promote efficiency, accuracy and workflow standardization. Micro is designed to meet the growing microbiological needs of the food processing industry. It presents data to establish a point of reference and consistently monitors the microbiology sampling process. These actions cultivate proactive control in the microbiological environment. Micro's standardizing method assists processing facilities with HACCP validation and helps reduce the risk of regulatory infringements. Features of LabSoft LIMS Micro include: true randomized sample site selection, scheduling, sample information entry, seamless communication to an external lab, customized reporting, action item tracking, process verification, and automatic E-mail notifications. The Micro Module is available beginning with LabSoft LIMS version 7.12. For details, visit http://www.LabSoftLIMS.com.

LabPlus Technologies Spins off from Desert Moon Technologies

Effective July 1, 2004, all business operations for LabPlus LIMS were spun-off from Desert Moon and are now managed under LabPlus Technologies. LabPlus Technologies retains all resources, employees, products, support, and services from the previous ownership of Desert Moon Technologies. They are aggressively moving forward to complete the next version of LabPlus along with new internet interface tools by the end of 2004, and are actively investing in additional business operations. For details, visit http://www.labplustech.com.

STARLIMS Public Health Projects

STARLIMS has undertaken a set of collaborative projects undertaken in conjunction with public health departments at county, state and federal levels. The project (known as "Sunrise") is aimed at creating "out of the box" configurable functionality to support a wide range of multidisciplinary processes consistent with guidelines set forth by the Association of Public Health Laboratories (APHL) and the Centers of Disease Control (CDC). This
functionality incorporated within STARLIMS, presents 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. STARLIMS is designed to receive samples from clinical, environmental, food testing, Bioterrorism, Chemical Terrorism, and other ad-hoc or planned
sample submissions. These samples are tracked, tested, reported and the information retained for epidemiological studies or submission to adjunct agencies such as the CDC. In addition to conventional LIMS functions, the
data collected on samples may include patient demographics, grant, study, environmental or other metadata. STARLIMS public health solutions 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 nature of STARLIMS relationship with the Public Health sector is based on an ongoing commitment to this partnership, assuring that new functionality and content developed for one PHL is accessible to all STARLIMS based PHL partners. The collaboration was initiated by the public health departments of Arkansas, Iowa, Kentucky and Virginia focusing on defining common use, design and implementation methodologies to adhere to the general standard provided by the APHL. Leveraging STARLIMS configuration tools, the system fully supports site specific modifications including interfaces to input data streams, reporting systems, and local Key Performance Indicators (KPI) and management metrics; support for specialized assays, managing state mandated testing programs not common to the APHL general model; and state specific billing or cost recovery processes. In parallel with the state programs, STARLIMS is now completing the first stage of a defined-phased project leading to the enterprise-wide deployment at the CDC's National Center for Infectious Diseases (NCID). The project includes more than 80 labs in areas of Bacteriology, Virology, Mycology and Parasitology with unique characteristics that affect sample control, test representation and results reporting. The project's goal is to balance the Agency's need to standardize with the Lab's needs to support many different processes and workflows The NCID is one of 12 centers, institutes, and offices within the CDC, focusing on preventing illness, disability, and death caused by infectious diseases in the United States and around the world.
For details, visit http://www.starlims.com.

Agilent Technologies Gains Exclusive Rights to Sell SSI's CyberLAB Enterprise Content Management System

Agilent Technologies Inc. and Scientific Software Inc. (SSI) have announced an exclusive agreement for Agilent to market, sell and support SSI's CyberLAB Enterprise Content Management System (ECMS). Agilent will market the product under its new family name -- Agilent Cerity -- to the pharmaceutical, chemical, petrochemical, forensic, environmental, homeland security, and food and beverage markets. CyberLAB ECMS is a Web-based electronic library that collects, organizes, indexes, stores, archives and shares electronic records -- from raw analytical instrument data and reports to compliance records, MS Office documents, PDF documents, molecular drawings, pictures and video. CyberLAB automatically extracts searchable metadata from each of the files, and provides powerful search capabilities and embedded viewers for many file types. As a result, knowledge workers find information faster and make more informed decisions. Agilent's current portfolio of laboratory software includes the Agilent Cerity chromatography data system and ChemStation analytical workstations, which are used to acquire, process and report data from analytical instruments. Agilent has also established a series of application integrations that provide open and seamless interfaces to enterprise resource planning (ERP) and LIMS. With the addition of CyberLAB, Agilent can provide customers with a portfolio of software for information management in the laboratory and beyond. For details, visit http:// www.agilent.com/chem/CerityECMS or http://www.scisw.com.

Thermo Electron Discontinues eRecordManager

The Informatics & Services division of Thermo Electron has discontinued its eRecordManager software product three years after its launch in July 2001. "Despite a great deal of initial interest from the market, sufficient sales have not materialized and the product has become commercially unviable", Billy McKnight, the Managing Director of Thermo's Informatics business. Existing eRecordManager customers will be supported by Thermo for five years. The rest of the Informatics business' software solutions, including its SampleManager and Nautilus LIMS products, Atlas Chromatography Data Systems (CDS) and the GRAMS suite of products, remain unaffected by the decision. As a consequence of the decision, the ongoing consolidation of Thermo's informatics development facility in Salem, NH into the divisions' new US headquarters in Woburn, MA has been accelerated. This is resulting in the imminent closure of the Salem site and the loss of seven staff. For details, visit http://www.thermo.com/informatics.

NIBSC Implements MediData Systems' ItemTracker Sample Tracking Software

MediData Systems Limited is pleased to announce that the National Institue for Biological Standard and Control (NIBSC) after using ItemTracker to manage the samples for a limited group of departments is now installing the sample tracking software site wide on all 300 institue computers. Pam Pipkin, Scientific Support Manager at NIBSC said "We began with inventory control of our Liquid Nitrogen storage facilities which was a straightforward inventory control project. This involves approximately 30 users. We then added the barcode reading and document linking facilities for another project, that of archiving products and linking simple documents. Finally, our confidence is such that we are making the package available to all members of NIBSC - about 300 users - by installing it on all computers throughout the Institute as part of the basic software." For details, visit http://www.itemtracker.co.uk or
http://www.nibsc.ac.uk.

Accelerated Technology Laboratories Partners with CoreTEC Systems & Solutions in Africa

Accelerated Technology Laboratories, Inc. (ATL), a leading supplier of Laboratory Information Management Systems (LIMS), has announced a foreign sales alliance with CoreTEC Systems & Solutions Ltd., headquartered in Kenya, Africa. CoreTEC's reputation for quality solutions and support is built upon a complete service to customers that extends from initial consultancy through to project implementation, training and maintenance and support. CoreTEC is a Microsoft Certified Business Solutions Partner and their staff, composed of professionals experienced in laboratory automation, computer consultation, software development, implementation, and training have the technical and analytical skills to advise and deploy mission critical laboratory data management solutions. CoreTEC will provide local technical support for ATL’s clients and will market and implement ATL’s LIMS products to analytical laboratories in Africa. ATL's Windows-based LIMS with Microsoft SQL Server and Oracle data management solutions include Sample Master Pro LIMS. For details, visit http://www.atlab.com.

QATrax Increases Scheduling Productivity

QATrax scheduling productivityhas increased three-fold due to enhancements in the new releases claims TraxStar. New releases of QATrax Global and QATrax Enterprise Editions were distributed to customers in May. Both Editions increase visibility over test lab workflow with particular emphasis on scheduling and re-scheduling. Optimizations in data retrieval enhance the effectiveness of the core Scheduling and Re-Scheduling functionality offered by QATrax. Providing real-time visibility across engineering groups and into test labs dispersed around the world has a significant impact on the time it takes to get new products to market. Decisions made from the vantage of real-time visibility reduce the uncertainty in the product testing cycle which, in turn, results in fewer delays in getting product to market. QATrax integrates Scheduling and Re-Scheduling functionality into the test request and testing process, rewarding management, engineers and technicians with increased efficiency. For details, visit http://www.traxstar.com.

Labtronics Inc. Releases New Toolkit for Validating Instrument/LIMS Interfaces

Labtronics Inc. has announced the release of version 3.2 of the Validation Tool Kit for their LIMS interfacing application LimsLink. The Validation ToolKit includes two separate components, a software application and a full documentation package, that provide automated assistance and detailed guidance for both IQ and OQ. Together they reduce the amount of time and resources required for conducting a thorough validation of a LimsLink implementation. The documentation portion of the Validation ToolKit includes testing procedures, tables, lists and charts that guide and assist in the IQ and OQ validation of LimsLink installations and methods. IQ and OQ Checklists cover items such as hardware, software and file verification, installation protocol, validation of the security components and validation and versioning of the interfacing methods. Using the documentation package as their guide, LimsLink users are able to take a thorough and structured approach to validation of their application. The software component of the Validation Toolkit can automatically run IQ each time LimsLink is used or on a regularly scheduled basis. In the event of a validation failure, the user can be automatically denied access to the application and email can be sent to supervisory personnel to advise them of the failure. Also
included in the software portion of the Validation ToolKit is a Method Documenter that automatically converts LimsLink methods to a text file that can be used to document and archive the interface's functionality. The Validation ToolKit provides laboratories that need to validate their LimsLink installation with a valuable resource for increasing the efficiency of their validation process. For details, visit http://www.labtronics.com.

Bio-Rad Releases Thirteen New ADME/Tox Databases

Bio-Rad Laboratories, Inc. has announced the release of thirteen databases that contain measured ADME/Tox
properties for a broad range of chemical compounds and cover seven endpoints, including Blood Brain Barrier, Human Intestinal Absorption, log D, log P, Mutagenicity, Plasma-Protein Binding, and Water Solubility. These databases are the result of internal literature research and external collaboration with various scientific
groups. Michelle D’Souza, Ph.D., Medicinal Chemistry Software Product Manager, remarked, "These new ADME/Tox data collections are a valuable addition to our in silico ADME/Tox portfolio. Scientists, particularly those involved in drug discovery, can benchmark the results of their own experiments against this data, validate
the accuracy of predictive ADME/Tox models, or build new models by using this experimental data as a training set for their model. For details, visit http://www.informatics.bio-rad.com.

EISC Announces Scalability for R&R Suite

Designed to directly automate and increase lab production while ensuring data quality and integrity through data automation, EISC’s Analytical Review & Reporting Suite (R&R Suite) is now scalable. R&R Suite provides scalability as well as one production solution across the entire lab (for volatiles, semi-volatailes/HPLC, pesticides/PCB’s, metals and general chemistry). EISC’s R&R Suite is middleware that focuses on increasing lab production while ensuring data quality and integrity by automating the analytical review, reporting and electronic data deliverables (including SEDD) with no change to the lab’s current analytical process. EISC is a software development and consulting firm specializing in scientific data automation with expertise in LIMS Implementation/LIMS rescue, automatic instrument interfacing, data validation, data integrity, data quantitation, bar-coding, document imaging/warehousing, and general lab data management. For details, visit http://www.eisc.net.

AEC Software Announces Strategic Partnership with UK-Based Computers Unlimited

AEC Software, a leading supplier of productivity and project-focused software, has announced a strategic alliance with London-based Computers Unlimited. Computers Unlimited (CU) will act as the exclusive distributor in the United Kingdom for AEC Software's award-winning project management product, FastTrack Schedule. CU has an extensive and successful track record in the UK technology industry as a premier distributor of leading edge products for the creative industry. CU joins a host of new partners that AEC Software is working with to distribute and localize its premier project manager, FastTrack Schedule. In addition to a recently released Japanese version, AEC Software's EU partners have recently released French, Italian, Dutch, and German versions of
FastTrack Schedule. For details, visit http://www.aecsoftware.com or http://www.unlimited.com.

ARC's New RFID Systems in the Manufacturing Supply Chain Study Released

According to ARC Research, use of passive RFID (Radio Frequency Identification) tags for product tracking is one of the major issues in today's manufacturing supply chain. Many RFID tag and reader manufacturers are already part of the gold rush surrounding the Wal-Mart, US Department of Defense, and other mandates, while numerous CPG, food, beverage, and other manufacturers who supply these customers continue to struggle to justify the use of RFID on their products. Pharmaceuticals, however, possess many characteristics that make RFID an attractive solution for manufacturers, and ARC believes this segment could represent another potential RFID gold rush after the original mandates take flight. Tracking and tracing capabilities are vital to pharmaceutical manufacturers for a variety of reasons, many of them regulatory. These increasingly necessary capabilities can be used to track pedigree or facilitate product recalls or other actions that necessitate the ability to track the product through the channel. RFID is particularly well-suited to one of the regulatory issues currently looming, anti-counterfeiting, and the US FDA has already recommended that RFID be part of a layered approach to counterfeit prevention that includes RFID, tamper-proof packaging, bar codes, and other forms of security such as hidden inks. While the early portions of the FDA timeline stress cases and pallets, by late 2007 it is likely that most item-level pharmaceuticals will be tagged as well. Chantal Polsonetti, ARC Vice President and author of the just issued report RFID Systems in the Manufacturing Supply Chain, explains: "The RFID market potential in pharmaceuticals is huge, with over 12 billion units as candidates for item-level tagging in the United States alone. Unlike the experience with retailer-driven mandates whose business value is distributed unequally throughout the supply chain, pharmaceutical manufacturers can easily justify using passive tags all the way down to the item level on the basis of tracking and tracing requirements. Pharmaceuticals also have a higher price tag and margin relative to retail products that could only accommodate item-level tagging at a tag price of five cents or less." ARC's analysis of the market for RFID Systems in the Manufacturing Supply Chain recognizes the profound pull inherent in this truly (customer) demand-driven, supply chain phenomenon, plus the counterbalancing effects of passive RFID's technological shortcomings, current lack of interoperability across vendor products, and continued struggle by manufacturers to arrive at an internal business case. The report provides strategic information including RFID tag, reader, and other hardware market size and potential, leading suppliers, key factors that contribute to market growth, market dynamics, and strategic issues that suppliers will face. For details, visit http://www.arcweb.com/res/rfid.

FDA Adopts New Standard for Submitting Clinical Trial Data

The FDA has developed a standard format for sponsors of human drug clinical trials to submit data to the agency. The Study Data Tabulation Model (SDTM) will accelerate the FDA's review of clinical trial data and new drug applications, the agency announced recently, and will provide a consistent framework for government, academia and industry to enhance data integration opportunities and reduce barriers to sharing the latest clinical trial data.
The adoption of SDTM is consistent with the FDA's Critical Path Initiative, which was launched in March to develop solutions to the task of ensuring that breakthrough medicines are safe and effective. The FDA's announcement comes on the heels of mounting pressure on pharmaceutical firms to publish all clinical trial results, whether positive or negative. For details, visit http://www.fda.gov.

FDA to Establish New Office of Oncology Drug Products

With an eye toward getting more cancer drugs on the market, the FDA will consolidate and restructure its divisions responsible for cancer drugs and therapeutic biologics. The two-pronged effort to encourage “a stronger and more consistent approach” to fighting cancer includes the creation of an Office of Oncology Drug Products (ODP) and a new crosscutting oncology program, said John Jenkins, director of the Office of New Drugs in the Center for Drug Evaluation and Research (CDER). The ODP, which will be housed in CDER, will be created through the consolidation of three existing areas within CDER responsible for the review of drugs and therapeutic biologics used to diagnose, treat and prevent cancer. The office will also include drugs and certain therapeutic biologics used in medical imaging, some of which are also used to detect, treat and monitor cancer, Jenkins said.The ODP should be fully implemented by April 2005 when the new-drug review staff from CDER moves into a new FDA facility in White Oak, Md., Jenkins said. The new office will improve the consistency of oncology drug review and policy, and it will bring together a critical mass of oncologists who will help develop new therapies, he added. For details, visit http://www.fda.gov.

FDA Should Scrap Part 11, Rely on Congress for eRecords Policy, PhRMA Says

The FDA should abbreviate or even withdraw 21 CFR Part 11 and instead rely on legislative measures passed by Congress to craft policy defining how drugmakers use erecords and esignatures in drug applications, biologics license submissions and other filings with the agency, according to a drug industry trade group. In comments submitted to the agency just prior to the closing of the docket, PhRMA recommended Part 11 “be rescinded and that [the] FDA rely on federal legislation that enables companies to utilize electronic records and signatures as part of the business they do with FDA, or that [Part 11] be dramatically abbreviated to achieve the same goal. Specific regulatory aspects of electronic records and signatures can be adequately dealt with through guidance documents.” The two pieces of legislation PhRMA refers to are the Government Paperwork Elimination Act and the Electronic Records and Signatures in Global and National Commerce Act, passed in 1998 and 2000, respectively. For details, visit http://www.fda.gov.

Risk Management Guidelines May Have Positive and Negative Effects

While the FDA's promulgation of three draft guidance documents on risk assessment and minimization will go a long way to establishing a framework for industry and the agency, some components of the guidances may actually delay the availability of new and beneficial drugs, according to PhRMA. The FDA released draft guidances on premarketing risk assessment, the development and use of risk minimization action plans (RiskMAPs) and good pharmacovigilance practices in May. The guidances demonstrate an increased emphasis on the balance between risks and benefits for patients and recognize that RiskMAPs should be used judiciously, wrote Alan Goldhammer, PhRMA's associate vice president of U.S. regulatory affairs, in a letter to the agency. On the other hand, several requirements in the draft guidances could have negative effects on the development of medicines and access to new drugs, PhRMA added. The emphasis on the desirability of data from active comparator drugs if an acceptable alternative exists, for example, amounts to the establishment of a new standard of approval for products that are not first-in-class or first therapy, PhRMA said. This new standard could encourage the FDA to request comparative trials on a more routine basis, thus moving beyond statutory requirements. For details, visit http://www.fda.gov.

FDA on Track to Approve More than 400 Generics in 2004

While generic patent battles over billion-dollar drugs get all the attention, the FDA has been quietly approving scores of generic applications targeting products for which patents are not being contested. As of June 30, the FDA's Office of Generic Drugs (OGD) had granted 162 full approvals and 45 tentative approvals. At this pace, the office projects it will issue 324 full approvals and 90 tentative approvals, for a total of 414 approvals in 2004, an OGD spokeswoman said. Last year, by contrast, the office approved a record 373 generic applications, with 284 full approvals and 89 tentative approvals. For details, visit http://www.fda.gov.

NME Applications Expected to Exceed 2003 Total

The FDA is on track to approve more new molecular entities (NMEs) this year than it did in 2003. For the first six months of 2004, the FDA approved 12 NMEs, compared to only seven for the comparable period in 2003 and 17 NMEs for all of 2002. The NMEs approved this year are tiotropium bromide (trade name Spiriva Handihaler); pemetrexed disodium (Alimta); cinacalcet hydrochloride (Sensipar); telithromycin (Ketek); human secretin (Human Secretin); insulin glulisine (Apidra); apomorphine hydrochloride (Apokyn); ovine hyaluronidase (Vitrase); tinidazole (Tindamax); azacitidine (Vidaza); rifaximin (Xifaxan); and trospium chloride (Sanctura). For details, visit http://www.fda.gov.

FDA Agenda to Focus on Label Changes, Export Rules for Rest of 2004

Final action on a rule governing labeling for human prescription drugs is set for October, according to the FDA's Semiannual Regulatory Agenda, published in the Federal Register. The rule is intended to reduce human error and would amend existing regulations governing the format and content of professional labeling for human prescription drug and biological products under 21 CFR 201.56 and 201.57. It would require that such labeling include a section containing highlights of the prescribing information and a section containing an index to prescribing information. Also on the agenda is final action to be taken in September on regulation setting out export requirements for unapproved new drug products, including biologics, for investigational use, the FDA said. For details, visit http://www.fda.gov.

Thermo Electron Releases SampleManager 2004 R2

Thermo Electron Corporation has released SampleManager 2004 R2 - a major new version of its flagship LIMS. SampleManager 2004 R2 features a host of Web interface enhancements. It also offers optional new capabilities
including integration of analytical instruments and advanced multi-dimensional study management supporting stability, clinical, DMPK and bio-analytical applications. SampleManager's new Web enhancements provide full interaction with laboratory data over a standard Internet browser. Users can receive samples, print barcode labels, produce reports, review and authorize samples and confirm their identity using advanced electronic signature features. Authorized users can also reallocate samples around the laboratory over the Web, while maintaining the chain of custody. A configurable browse feature offers users the ability to personalize their view of the data. The highly flexible and scalable integration solution for analytical instruments now available with SampleManager 2004 R2 facilitates the automation of laboratory functions, streamlines system administration an offers advanced mapping and parsing functionality for instrument output. Data is automatically and securely captured from instruments, eliminating potential transcription errors and improving the flow and management of
laboratory data. A standard interface is used within the lab and around the organization to integrate all types and brands of instruments, thereby simplifying operations, and offering the efficiencies and compliance benefits of increased automation. Rather than conventional PC-based instrument integration applications, a scalable architecture based on Microsoft .NET technology is utilized, with no requirement for extensive custom coding The advanced multi-dimensional study management solution now available with SampleManager 2004 R2 is designed to support a range of study-based environments, including stability, clinical, DMPK and bio-analytical
applications. For details, visit http://www.thermo.com/informatics.

New MSC-LIMS Version 3.0 Lowers Total Cost of Ownership

Mountain States Consulting, LLC, has announced the release of MSC-LIMS version 3.0, an affordable LIMS which lowers total cost of ownership through its new Microsoft Office-independent installation software, new customization features, streamlined distribution of software updates, and new XML configuration files. Developed with Access 2002, the new version’s installation software completely isolates MSC-LIMS 3.0, preventing any conflicts with Microsoft Office installations. It installs cleanly on any workstation regardless of which version of Office is already installed. Future installs, reinstalls, uninstalls or upgrades of Office will have no affect on MSC-LIMS 3.x, greatly simplifying system installation and administration. Neither Microsoft Office nor Microsoft Access is required to run MSC-LIMS 3.0. Site-specific customizations are now easier to develop and maintain. Version 3.0 isolates customizations and provides “hooks” to add custom features, such as newly dedicated screen real estate for custom fields, replaceable system reports, and event models to alter standard system behavior or add unique business rules. System administrators can use these streamlined capabilities to apply future MSC-LIMS version updates without reapplying customizations. Automatic updates allow system administrators to distribute updated MSC-LIMS software to all LIMS workstations. To maintain workstation stability in environments with a locked down Windows registry and to enable user-specific roaming settings in Terminal Services or Citrix installations, workstation configuration settings are now saved in XML files instead of the problematic Windows registry. MSC-LIMS is a complete laboratory information management system 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. Prices start at $500 per user per year for MSC-LIMS’ Annual Subscription License. For details, visit http://www.msc-lims.com.

Autoscribe Announces New LimsLink Software

Laboratories can now raise productivity by linking a wide range of instruments across a common interface platform using the new LimsLink software from Autoscribe. This powerful Windows based software can link instruments and LIMS (such as Autoscribe Matrix LIMS) into a seamless automated solution to maintain data integrity across an entire laboratory. The versatile two way communication helps manage data flow to and from various sources,
whilst flexible data processing and configurable user displays address many needs. LimsLink reduces the level of technical analyst involvement through direct data transfer and raises efficiency by automating the collection, calculation and reporting of laboratory data. Comprehensive reports with data from multiple instruments are easy to create, whilst common statistical SPC tools have been incorporated. User security access has also been addressed to meet the latest ISO standards. Laboratories would typically use LimsLink to generate work lists from a LIMS, communicate with various instruments, transfer work lists to an instrument, combine results from multiple instruments, review results and automatically perform calculations. An optional control module is also available to automate various instruments such as robots, samplers, detectors, meters, pumps and dilutors through an RS232 link. For details, visit http://www.autoscribe.co.uk.

AMO Selects Newton LIMS from InnaPhase for its QC Manufacturing Facility in Spain

InnaPhase Corporation, a world-leading provider of enterprise LIMS solutions, has announced that Advanced Medical Optics, Inc. (AMO), has purchased licenses for its Newton LIMS to handle quality control data management at AMO's manufacturing facility in Alcobendas, Spain. "In Newton, we have found a LIMS that meets the vast majority of our requirements right out of the box," said Mary West, vice president and chief information officer for AMO. "With such robust functionality, the Newton product enables us to meet our mission-critical project deadlines. In addition, Newton takes full advantage of modern systems architecture and widely accepted technologies, which falls in line with AMO's corporate IT strategy and allows us to easily maintain and support the LIMS." A purpose-built solution from InnaPhase's Pharma LIMS Suite, Newton LIMS was developed to handle information management functions specific to pharmaceutical and biotechnology organizations, such as batch release, quality control, formulation, stability and analytical development in pharmaceutical laboratories. Advanced Medical Optics is a global leader in the development, manufacturing and marketing of ophthalmic surgical and eye care products. For details, visit http://www.amo-inc.com or http:///www.innaphase.com.

Group Logic Releases OEM-Only AppleTalk Protocol for Windows XP

Group Logic, developer of network workflow products, has announced the release of an OEM-only version of its ExtremeZ-IP product line for Windows XP Professional that includes the AppleTalk network protocol. This solution fills the gap left by Microsoft's discontinuation of Windows 2000 Professional OS and its subsequent removal of AppleTalk from the replacement Windows XP Professional OS. Prior to the release of Group Logic's product solution, ISVs (Independent Software Vendor) had been forced to migrate to the more expensive and hardware intensive Windows 2003 Server to obtain this key networking protocol. Group Logic's OEM solution delivers the AppleTalk protocol and other valuable cross platform features that make it viable for ISVs that need AppleTalk. Currently, it is the only solution on the market that fully integrates both Mac OS X and Mac OS 9 with Windows XP Professional and Windows 2003/2000/NT Server versions as well as Windows 2003 Storage Server. ExtremeZ-IP provides authentication against Active Directory or other compatible directory servers and greater permissions control with the flexibility of using either the Macintosh or Windows permissions model. Other powerful features include queue management, logging, PostScript Printer Driver (PPD) file management, clustering and support for numerous Windows print services. For details, visit http://www.grouplogic.com.

National Instruments and Agilent Technologies Extend Functionality, Flexibility of Analytical Instrumentation with LabVIEW

National Instruments and Agilent Technologies Inc. have announced a joint initiative to create NI-certified LabVIEW instrument drivers for control of Agilent gas and liquid chromatographs. These plug-and-play drivers extend the analysis, automation and I/O integration capabilities of Agilent life science instruments, enhancing their application to custom scientific endeavors such as gas stream analysis in fuel-cell development and hydrocarbon processing. Through LabVIEW instrument drivers, scientists and researchers can quickly automate Agilent instrument operation, easily integrate chromatography measurements with additional analytical instrumentation data and use more than 450 built-in analysis functions such as peak detection and data calibration to create custom analysis routines for specific experiments and applications. In addition, they can use Instrument I/O Assistant in LabVIEW 7.1 to interactively write commands, read responses and automatically parse data from Agilent instruments, which cuts development time by up to 80 percent. National Instruments has released LabVIEW instrument drivers for the Agilent 3000 Micro GC and is currently working on drivers for Agilent 6890 and 6850 gas chromatographs and 1100 liquid chromatographs, which are scheduled to be released later this year. For details, visit http://www.agilent.com or http://www.ni.com/nati.

Thermo Electron Introduces Web Seminar Series

Thermo Electron Corporation will hold a series of Web Seminars covering a variety of timely issues that confront today's life and analytical science organizations. Seminar topics and speakers were selected that offer value to Laboratory, IT and Business Managers who are focused on reducing costs and gaining efficiencies in their
organizations. These interactive sessions utilize the latest web conferencing technology and include the opportunity for Q&A with the presenters. There is no fee for the seminars, which are generally kept to under an hour. The initial round of seminars scheduled over the summer months will provide registrants with latest insights and practical guidance on regulatory compliance and such informatics issues as integrating the laboratory with the global enterprise, global deployment of LIMS and lowering total cost of ownership through standardization. Topics covered include: Business Benefits of Regulatory Compliance - Is 21 CFR Part 11 Revolutionary, or Just Plain Common Sense?; Lowering the Total Cost of Ownership of LIMS Through Standardization; LIMS integration via Web services architecture; Optimizing LIMS through SAP integration; Best Practices and Lessons Learned in Multi-site Deployment of LIMS - A Technical Perspective; and, The New Age of Configurability and Flexibility in LIMS design for Life Sciences and High Throughput Screening. Seminar details and online registration are available at http://infolinks.thermoinformatics.com/seminars.

Agilent Technologies Announces Life Science Tool for Standardized Measurement of RNA Quality

Agilent Technologies Inc. has introduced a tool to measure RNA quality and grade it on a quantitative scale of 1 to 10. This measurement, known as the RNA integrity number (RIN), makes it possible for scientists to objectively
measure and communicate the quality of RNA used in experiments, a critical need in the development of advanced therapeutics for cancer and cardiovascular disease. Until now, scientists have been unable to reliably compare the quality of RNA -- a genetic molecule used extensively in biological research -- between experiments or across laboratories. This limitation has greatly inhibited the reproducibility of microarray-based gene expression experiments and real-time polymerase chain reaction (PCR) experiments, both of which are popular in cancer and cardiovascular research. It has also hindered the industry's ability to submit verifiable data from such experiments for FDA review and to apply these technologies to clinical studies, therapeutic development and diagnostic development. Because RNA quality can affect experiment results and research conclusions, many scientists believe that demonstration of a minimum standard of RNA quality should be a criterion for data submitted to peer-review publications and government agencies, such as the FDA. RINs are assigned to sample RNA using new, neural-network based software that works with the Agilent 2100 Bioanalyzer and RNA Nano LabChip kits to assess RNA quality. The RIN software helps scientists measure the integrity of total RNA samples from eukaryotic (not viral or bacterial) organisms. For details, visit http://www.agilent.com.

ABB Supplies Industrial IT Solution to Ras El Ma Cement Plant, Morocco

ABB, a leading power and automation technology group, has successfully delivered the equipment for the new cement grinding and packing plant of Holcim Morocco at Fès-Ras El Ma Plant. This new plant is currently under commissioning; the first cement bag was delivered mid-May 2004. Since then, Holcim Morocco decided to increase the production of the cement by installing a second cement mill and packing plant. The contract was awarded to Kawasaki Heavy Industries Ltd Japan (KHI) in 2002. ABB Switzerland was selected as the electrical & automation equipment subsupplier. The ABB scope of supply comprises the medium voltage distribution, transformers, low voltage distribution (MCC), Drive IT medium and low voltage fix and variable speed drives, Operate IT and Control IT process control system and instrumentation and lighting equipment. The appropriate engineering and commissioning are also part of the ABB scope. As a result of a close collaboration between Holcim, KHI and ABB a high automation degree could be reached. The whole mill section can be started-up by one mouse click. The cement plant in Ras El Ma is part of Holcim Morocco, a domestic group in the Moroccan cement industry. Holcim Group (Holcim Ltd) (www.holcim.com) is one of the largest cement producers in the world with production units in some 70 countries and with 47000 employees. For details, visit http://www.abb.com.

ABB Optimizes Cement Processing for Cement Australia

ABB has implemented Optimize IT Expert Optimizer system for the control and optimization of the cement kiln at Cement Australia’s Gladstone Works and the cement mills at the Bulwer Island Works, Australia. Cement Australia Pty Ltd. is owned 50 percent by Holcim, 25 percent by Hanson (UK based ready-mix and aggregate company) and 25 percent by Rinker (Australian and US heavy construction materials group) and is a result of a merger in 2003. Optimize IT Expert Optimizer is a computer-based system for controlling, stabilizing and optimizing cement production processes. The principal concept is that Expert Optimizer mimics the actions of an “ideal” cement plant operator, while focussed on achieving particular targets. It implements automatic on-line set point adjustments to achieve the targets. This project is delivered within ABB’s global frame agreement with Holcim Group for the supply of expert system applications to their cement works globally. This project is the first one completed of several planned in the Australasia region. The kiln system was commissioned in late 2003 at the Gladstone works, with the cement milling system subsequently commissioned at the Bulwer Island works in Brisbane. Results show that Gladstone now has improved kiln stability, particularly when burning SBF (Solvent fuel). Due to the improved kiln stability and free-lime standard deviation, the free-lime target can now be increased from 1% to 1.5%, which allows a net improvement in energy used per ton of clinker produced. Increases in average daily tonnage have also been achieved. The cement mills are also demonstrating improved production throughput without compromise to the energy consumption or quality. For details, visit http://www.abb.com.

Labtronics' Nexxis CAL Connects Instrument Calibration with Everyday Analysis

Nexxis CAL from Labtronics Inc. is a full-featured calibration management solution that makes calibration management an integral part of every analysis that a laboratory runs. Nexxis CAL perofrms automatically scheduling, documenting and reporting laboratory instrument calibrations. It can collect calibration data directly from instruments; automate calibration SOPs; and, integrate directly with analytical SOPs. Nexxis CAL interacts bi-directionally with both the analyst and the instrumentation to automatically collect calibration data from the instrument, check the data against acceptable limits, determine whether the instrument passes or fails the calibration and store the results in the calibration database. Nexxis CAL can then be integrated with automated analytical procedures that are being controlled through the main Nexxis application. An automated procedure can check the Nexxis CAL database to see if the instrument being used is due for calibration. If calibration is required, Nexxis CAL can automatically calibrate the instrument before continuing with the analysis. For details, visit http://www.labtronics.com.

New Beckman Coulter Software for CEQ Genetic Analysis System Enables Data Management and Visualization

Beckman Coulter, Inc.has announced CEQ 8800 Software v.9, providing new tools for advanced genetic data analysis. The new software simplifies the interpretation of genotype and phenotype information for subsequent association and linkage studies. It also provides tools to view, edit and print pedigrees as well as to create subgroups for downstream analysis. This new software for the CEQ 8800 system reduces the time required to manage, mine, query and format data, with visualization and graphics functions that allow interactive exploration and enhanced interpretation of data sets. The new package software also formats the data for easy export to standard genetic analysis packages. Part of Beckman Coulter's GenomeLab family of products, the CEQ 8800 automates and integrates the majority of genetic analysis functions into one flexible, easy-to-use system that adapts to changes in sample type and complexity. For details, visit http://www.beckmancoulter.com.

Agilent Technologies Introduces Online Training for Gas Chromatography Instruments

Agilent Technologies Inc. has introduced online training for gas chromatography, a technique highly used in petrochemical, hydrocarbon, chemical and environmental industries, where productivity and uptime are critical. This is the first in a series of Web-based training modules that will provide convenient, low-cost and in-depth instruction in the use of Agilent's analytical instruments. The training modules focus on the maintenance and operation of specific instrument components, with interactive animations that dynamically demonstrate how components work. The modules cover information immediately applicable to the work environment, including instrument theory, operation, routine maintenance, common problems and solutions. As a laboratory adds new components to an Agilent system, these online training modules provide a means to quickly expand or refresh operator skills. Training modules are available in two forms: e-Learning on Demand and e-Learning Live. e-Learning on Demand modules are self-paced courses that laboratory professionals can take at any time. e-Learning Live modules offer 60- to 90-minute courses taught by a live instructor at scheduled times. Users interact with the instructor by telephone or through an online chat feature. For details, visit http://www.agilent.com/chem/elearning.

Gloria Metrick Honored by Independent Computer Consultants Association

The Detroit Chapter of the Independent Computer Consultants Association has announced that one of their members, Gloria Metrick, has been named to the Independent Computer Consultants Association (ICCA) National Honor Council. This award was given at the ICCA National Conference in Toronto, Canada. The Honor Council is comprised of past Board of Directors members who have made outstanding contributions to the association. Upon admittance to the Honor Council, said member becomes a resource for the current national board when special help or advice is desired. Within the ICCA, Gloria Metrick is currently a national committee chair, as well as the Program Director for the Detroit chapter, and has held other offices within the organization at both the national and the local levels. Gloria is the owner of the Okemos, MI-based GeoMetrick Enterprises. She has worked with laboratory data for over fifteen years throughout many aspects of the business. She has been called upon to write articles and give talks both within and outside of her industry. For details, visit http://www.icca.org or http://www.GeoMetrick.com.

Bruker Daltonics Appoints Dr. Ian Sanders as Assistant Vice President for European Life-Science Sales

Bruker Daltonics Inc. has announced that Dr. Ian Sanders has been appointed as its Assistant Vice President for European Life-Science Sales. He will share responsibility for the management of the Company's marketing, sales, applications and customer support activities in Europe, and he will also join the Bruker Daltonics global management team. Dr. Sanders joined Bruker Daltonics in 2000 following a ten-year career in drug discovery research for both large pharmaceutical and venture biotechnology companies. Initially responsible for the UK
business, in 2002 his role expanded to manage life-science sales in the UK, Scandinavia and The Netherlands. He holds a Ph.D. in drug discovery technology from The University of Bath, UK. For details, visit http://www.bruker-biosciences.com.

Bruker Daltonics Appoints Hans Baum as Vice President of European Operations

Bruker Daltonics Inc. has announced that Mr. Hans Baum has been appointed Vice President of European Operations. Mr. Baum will be responsible for the management of Bruker Daltonics' European operations, including sales, distribution and service, as well as European based manufacturing. After serving in the German Bundeswehr as NBC defense officer, Mr. Baum started his business career with Bruker Daltonik GmbH in Germany in 1987, and in 1988 he became the MM1 Product Manager. In 1990, Mr. Baum was promoted to Sales Manager with responsibility for sales and applications in Germany for life-science systems and NBC detection systems. In 1997, he joined the Bruker Daltonik GmbH board of management, and in 1999 he became a Managing Director. For details, visit http://www.bruker-biosciences.com.

FDA Issues Three Guidances on Developing Medical Imaging Drugs

The FDA has released three final guidances to help firms prepare and submit applications for medical imaging drugs and biological products - agents that are used solely to diagnose and monitor diseases or conditions rather than to treat them. Medical imaging agents are generally governed by the same regulations as other drug and biological products, the FDA said. The agents can be classified into at least two categories: contrast agents and diagnostic radiopharmaceuticals, according to the guidances. The three final guidances titled "Developing Medical Imaging Drug and Biological Products," published in the Federal Register, can be viewed as "Part 1: Conducting Safety Assessments" at http://www.fda.gov/OHRMS/DOCKETS/98fr/5742prt1.pdf; "Part 2: Clinical Indications" at http://www.fda.gov/OHRMS/DOCKETS/98fr/5742prt2.pdf; and "Part 3: Design, Analysis and Interpretation of Clinical Studies" at http://www.fda.gov/OHRMS/DOCKETS/98fr/5742prt3.pdf.

FDA Timeline for New SPL Formatting Requirement Postponed

The FDA has pushed back the timeline for implementing its structured product labeling (SPL) file format requirement, effectively extending the deadline for companies to begin using the new standard when submitting drug-labeling data. The change from portable document format (PDF), the current labeling specification, to SPL will require a longer transition period stretching from June 8 to roughly about the middle of next year, said Randy Levin, director for health and regulatory data standards and associate director for medical information at the FDA's Center for Drug Evaluation and Research. As a result, the year-end deadline originally envisioned by the FDA will be extended by at least six months. The actual date for the shift to SPL is being pegged to the launch of the electronic labeling information system, which reviews the content of label changes to prescription drugs. That system is expected to be up and running by mid- to late June 2005, said James Rinaldi, the FDA's chief information officer. The transition date to SPL for the labeling data of all drugs is planned for 2006, when the electronic listing system, which will include product codes, is fully functional, said Levin. For details, visit http://www.fda.gov.

Public Part 11 Meeting Cancelled, Some Confusion Remains

The FDA's decision to cancel its June 11 public meeting to address possible Part 11 rule revisions has exacerbated an already confused situation in which industry has been unable to get a clear fix on the agency's direction regarding electronic signatures and electronic recordkeeping. The meeting was called off in observance of the national day of mourning for former President Ronald Reagan. The agency has said it would not be rescheduled. Industry experts say if Part 11 were overhauled, the process could take years, leaving FDA-regulated companies with little or no guidance from the agency as new technologies for erecords and esignatures become available or when new compliance issues arise. Comments are being accepted until July 9. To submit comments electronically, go to http://www.fda.gov/ohrms/dockets/ and enter docket No. 2004N-0133 into the search field.


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