LIMSource News: What's New in August 2010

• LabLogic Systems Introduces PETra LIMS

• Agilent Technologies' Announces Release of Agilent OpenLAB Electronic Lab Notebook 4.1

• Labtronics Introduces Labtronics Connector Software for LIMS and ELNs

• Autoscribe Matrix Gemini Gains SAP Certification

• Thermo Fisher Scientific Demonstrates Accelerated Method Development for Food Safety and Environmental Testing Using MS Software

• LabVantage Announces New Office in Monza, Italy

• ATL Establishes Partnership with ANDIA LTDA to Sell LIMS Solutions

• Process Analysis & Automation Releases Overlord3

• Autoscribe Software Module Assists in Grading Product Batches

• Locus Technologies Wins New Greenhouse Gas Verifications Contracts

• Elsys Instruments Releases New Software to Manage Multiple Elsys' Data Acquisition Instruments via LAN

• Genedata Releases Patent Analysis Software Jointly Developed with DSM

• Feds to Investigate Big Pharma’s Foreign Activities

• FDA to Start Part 11 Inspections after Finding Compliance Issues

• FDA's Proposed Classwide Opioid REMS Rejected by Advisory Panel

LabLogic Systems Introduces PETra LIMS

LabLogic has introduced a new PET process management LIMS called PETra that has the cure for one of the industry’s biggest quality headaches - maintaining up-to-date records of the components that make up each radiopharmaceutical. Its comprehensive inventory management module is an accurate and efficient alternative to paper records that keeps track of the availability of items in stock, their location, details of QC tests they have passed, and whether they are still within their expiry date. PETra records a complete chain of custody, from order through receipt and QC analysis to use in a batch, making it easy for users to document their inventory items, regular suppliers and couriers. Each item can be listed with the QC checks that must be carried out before it can be released for use in production. It also has a unique barcode that automates the identification of materials during batch preparation. Groups of items such as starting pre-cursor chemicals, vials and the like can be brought together in order to make a ‘kit’ specific to a product method. As items are used during synthesis the inventory is automatically adjusted, and re-order limits for each is flagged up as stocks are reduced. "PETra’s ability to maintain stock records has been highlighted as a key function by our prospective users" said Huw Loaring, LabLogic systems director. "Having to check that dozens of separate components are in-stock and within their expiry dates before embarking on a new synthesis is a time-consuming process, but PETra makes recordkeeping easy because the loop from synthesis, QC acceptance and use is maintained within the database." For details, visit http://www.lablogic.com.

Agilent Technologies' Announces Release of Agilent OpenLAB Electronic Lab Notebook 4.1

Agilent Technologies Inc. has announced the release of its OpenLAB Electronic Lab Notebook (ELN) version 4.1. The new version offers scientists in analytical research and development an optimized way to document and share experiments and results. OpenLAB ELN v4.1 introduces experimental templates that enable scientists to create, share and reuse their own custom experiment views. The new flexible templates facilitate data entry by allowing scientists to view the experiment desktop as they prefer. These templates can be designed for SOP-driven processes, increasing laboratory efficiencies. Agilent has also streamlined the analytical request workflow by reducing the number of steps between request and result. This dramatically improves lab productivity. A specific analytical module has been added for documenting analytical methods, generating sequence files and capturing results. The new module facilitates report creation across one or more samples and techniques. Chromatograms and result files from Agilent ChemStation, Waters Empower or other chromatography data systems (CDS) can be automatically uploaded and associated with the experiment through the seamless integration with Agilent OpenLAB ECM scientific data management system. Agilent offers the complete solution. In addition, the new delegation workflow facilitates collaboration. Multiple scientists can collaborate on a single experiment, enter data and results from multiple techniques on a single sample or multiple samples. Audit trails are maintained in an environment that delivers the highest level of intellectual property protection. "Ideally, software helps people be more productive with very little additional thought or effort," said Bruce von Herrmann, vice president and general manager, Agilent Software and Informatics. "This is the motivation behind the entire Agilent OpenLAB portfolio of laboratory systems." OpenLAB ELN is a Web-based scalable, integrated system to manage experiments and results. It is designed for multiple disciplines including analytical chemistry, synthetic/medicinal chemistry, biology and other research environments. OpenLAB ELN supports 21 CFR Part 11 requirements and is built around an open architecture. For details, visit http://www.agilent.com.

Labtronics Introduces Labtronics Connector Software for LIMS and ELNs

Labtronics has announced that LimsLink has been expanded to support OpenLAB version 3.3 with a connector between the programs. This connector makes it easy for laboratories to connect instruments to both a LIMS and OpenLAB ECM at the same time. Using the product, a single parser needs to be defined for each instrument. Once the program understands the data, it is able to send results to LIMS, and metadata to OpenLAB ECM. Customers already using the software can add this extra functionality without major changes to their current interface methods. It is also able to exchange data between the LIMS and OpenLAB ECM. For example it is able to transfer LIMS sample information to the ECM. It is also able to take the OpenLAB ECM URL that points to the raw data file and send it to LIMS. With this information the analyst can now click on the URL in LIMS and immediately see the raw data file associated with any results. It can also interface other third party systems, such as ELN or SAP, to OpenLAB ECM. For details, visit http://www.labtronics.com.

Process Analysis & Automation Releases Overlord3

Process Analysis & Automation Ltd (PAA) has released Overlord3, a laboratory automation software combining event and time driven schedulers. Ovelord 3 provides ease of use, efficiency and reliability. Overlord3 presents the optimum solution. Users only define a procedure for one plate; Overlord3 does the rest. Setting-up and modifying procedures is equally simple. Overlord3 is simple to run, telling users where to load the labware and providing estimates of the time to complete the assay. Overlord3 advanced error recovery enables custom retry procedures to be implemented. As requirements change, the library of more than 350 instrument drivers, enables users to change or add instruments in a simple and cost effective manner. For details, visit http://www.paa.co.uk/labauto/products/software/f-overlord3.asp.

Autoscribe Matrix Gemini Gains SAP Certification

Autoscribe has announced that their Matrix Gemini 5.2 LIMS software has recently been certified by SAP AG for integration with SAP PI 7.1 via their integration scenario NW-XI-CNT 3.0. The testing, carried out by SAP Labs India, is another illustration of the ability of Matrix Gemini to integrate into an organization's IT infrastructure to provide joined up information and data transfer from one system to another. SAP certification was a requirement in a recent customer specification document and without the integration certification Autoscribe would have been unable to bid for this significant order. Many large organizations have this same requirement for an internationally recognized standard so gaining certification is a key factor for these potential customers. Autoscribe's Managing Director John Boother said "SAP Certification is a significant factor; it will open up further opportunities for companies to adopt Matrix Gemini LIMS in their laboratories. Customers now have an additional assurance that Matrix Gemini LIMS will integrate with their SAP system providing a tried and tested communication path allowing information to pass from one system to the other." For details, visit http://www.autoscribelims.com/lims.

Thermo Fisher Scientific Demonstrates Accelerated Method Development for Food Safety and Environmental Testing Using MS Software

Thermo Fisher Scientific Inc., the world leader in serving science, has announced the availability of a new video which shows the productivity benefits of its Thermo Scientific TraceFinder analytical software for food safety and environmental testing laboratories. The video shows how TraceFinder software allows LC-MS/MS users to reduce method development time from hours or days to minutes, and enables rapid and easy data review and reporting. TraceFinder analytical software, available in both English and Chinese, operates on the Thermo Scientific TSQ Series triple quadrupole mass spectrometers, which quantitate and confirm hundreds of compounds in a single experiment. With its easy workflow to acquire, review and report data, TraceFinder makes routine screening and quantitation of contaminants a simple process. The software unifies data acquisition, data review and QA/QC workflow on LC-MS/MS instruments. The video shows how TraceFinder's extensive menu of preconfigured methods makes it simple to select the assay, build the sample list, set the report options and submit samples for analysis. TraceFinder provides an array of predefined reporting templates and allows customizable reporting, enabling users to quickly tailor reports to fit individual needs. In addition, the data review process is simplified with software that automatically highlights data requiring attention. Data can be effectively reviewed at-a-glance, making screening for routine contaminants an uncomplicated process. With this new demonstration video, MS users in environmental and food safety laboratories worldwide can understand the benefits of TraceFinder before integrating the software into their laboratories. For details or to watch the five-minute video demo, visit http://www.thermoscientific.com/tracefindervideo.

LabVantage Announces New Office in Monza, Italy

LabVantage has announced the opening of its new office in Monza, Italy. Located about 12 miles northeast of the capital city of Milan, Monza is the 3rd largest city in Lombardy, one of most important economic regions of Italy. "This new office not only serves as the strategic business development center for the European market, but also enables LabVantage to provide comprehensive training and prompt client services to both our local and regional customers in EMEA," affirms Paolo Concio, Director of European Sales of LabVantage. "Particularly, we will soon launch a series of on-site training programs at the new facility, conveniently located in the same office building, to offer our customers an enhanced, interactive, and hands-on learning experience on SQL*LIMS and SAPPHIRE Laboratory Information Management Suite (LIMS)." Headquartered in the United States, LabVantage has established a strong direct presence with local domain experts throughout Western Europe, including the United Kingdom, Germany, The Netherlands, Sweden, Belgium, France, Spain, and Italy. Moreover, LabVantage's customers also receive 24/5 customer support and are able to attend the customer events, such as Online INFORM Symposiums and user group meetings, in their respective local language. "With a vast customer base spanning multiple industries, LabVantage is well-recognized as the worldwide industry leader, providing and supporting the LIMS software behind many organizations' success," states Pat Pijanowski, Chief Operating Officer of LabVantage. "Through leveraging the proximity of this office, we will continue to realize our promise of ensuring customer satisfaction, by fostering closer collaborations and stronger partnerships with our clients and partners across EMEA." For details, visit http://www.labvantage.com/companyinfo/contactus/locations.html .

ATL Establishes Partnership with ANDIA LTDA to Sell LIMS Solutions

A ccelerated Technology Laboratories, Inc. (ATL) has established a partnership with ANDIA LTDA. to sell LIMS solutions in Colombia ANDIA, a leading supplier of laboratory equipment supplies and solutions, is now an ATL Certified Sales Agent and will market and sell ATL's Sample Master LIMS and laboratory automation solutions in Colombia. ATL has provided LIMS solutions for a number of industry segments including government, environmental, water/wastewater, commercial testing, food and beverage, mining, biotechnology, industrial hygiene, materials testing and agriculture. ATL's Vice President of Sales and Marketing, Dr. Christine Paszko commented, "We are very excited by the opportunity created by this partnership. ANDIA has a very strong reputation in Colombia as a provider of laboratory solutions and we feel confident they will represent ATL very well as we expand into Central America." ANDIA has a strong technical support organization that provides the total solutions to environmental laboratories including installation, repair and calibration services for the products it sells. Miriam Hertz, Sales Manager for ANDIA commented, "This represents a great opportunity for ANDIA and for Columbian organizations that will benefit from implementing this excellent tool for laboratories." For details, visit http://www.atlab.com.

Autoscribe Software Module Assists in Grading Product Batches

Autoscribe Ltd has published information about their Matrix Gemini Grading Module, designed to assist manufacturing companies to classify batches of product by grade or quality. Often companies that use batch manufacturing have a single process from which they want to supply multiple customers; however, the customers may have different specifications. Alternatively, the company may sell different grades of the product from their manufacturing process each with its own specification. The specifications can be based on the customer, destination or other criteria. Different specifications may have different test limits and sometimes require different tests. The Grading Module, which is used with Matrix Gemini LIMS, allows users to set up a series of specifications for a single product. Once the product has been manufactured and tested the multiple specifications can be applied retrospectively to determine which are met by the manufactured batch. This means that the material can then be allocated to a specific customer order or held in stock as a specific grade ready to be shipped. Autoscribe's Matrix Gemini software is fully configurable using the in-built Configuration Tools. The configuration can be carried out by either Autoscribe staff or by the user and requires no programming skills or coding. For details, visit http://www.autoscribelims.com/lims.

Locus Technologies Wins New Greenhouse Gas Verifications Contracts

Locus Technologies (Locus), an industry leader in web-based environmental compliance and information management software, has been selected for over a dozen new greenhouse gases (GHG) verification services contracts. The GHG verification services cover facilities in California that are regulated by the California Air Resources Board (CARB). Locus is accredited as a verification body through CARB and has Lead Verifiers certified in all reporting sectors, including cement plants, refineries, and electrical transactions. As a part of these contracts, Locus Lead Verifiers will perform mandatory verification of CO2 emissions at selected California facilities. While verification is a requirement this year through AB32, companies are also using 3rd party verification to promote their brands and the accuracy of their emissions information. The new GHG verification contracts include the following companies: Ameresco, Cardinal Cogen Inc., City of Oxnard, DG Fairhaven Power LLC. (owned by Marubeni Corporation), General Chemical, Lehigh Southwest Cement, Monterey Regional Waste Management District, Roseburg Forest Products, SRI International Cogen (operated and managed by International Power Technology Inc.), United Airlines, and US Pipe & Foundry. Several of the new awarded contracts cover multiple facilities. “We are very pleased to have been selected by so many well-recognized firms for GHG verification services. Locus continues to expand its carbon practice at a rapid pace. Coupled with our carbon software services and domain expertise in all three key AB 32 reporting sectors in California including cement, refineries, and electrical transactions, Locus is becoming a partner of choice for all companies wishing to be credible in their carbon reporting needs.” said Neno Duplan, President and CEO of Locus. For details, visit http://www.locustec.com.

Elsys Instruments Releases New Software to Manage Multiple Elsys' Data Acquisition Instruments via LAN

Elsys Instruments, a leading manufacturer of custom and standard fast, high-precision data acquisition systems, has upgraded its client-server-based transient recorder application software. Designed for use with Elsys' turnkey TraNET Transient Recorders and its TPCX data acquisition modules, which form the heart of the modular TraNET systems, the new TransAS 3 software remotely controls the data acquisition equipment over 1 Gbit Local Area Networks (LANs) from any location worldwide. For a limited time, a free download is available for measurement professionals conducting simple data acquisition to complex FFT analysis. Installed in seconds and effective within minutes without programming, TransAS 3 software enables easy, rapid configuration of several data acquisition channels for various measurement tasks. For maximum productivity, complete settings and traces related to a project can be stored and recalled from disk, and one or several users can work with predefined GUI-layouts and hardware configurations. Advanced triggering allows the transient recorder to capture rare events as well as signal anomalies. The unique event controlled recording (ECR) mode that offers automatic recording without dead-time, combined with other powerful data acquisition modes including scope, block and continuous, allow for gap-free, real-time recording to the disk, giving the user optimum flexibility to tackle any measurement problems. Users can select the number of channels displayed in one graph as well as how many graphs are viewed on screen for comfortable viewing. Since a graph may have multiple areas, each with multiple rulers, the ability to visualize complex wave shapes is virtually limitless. Showing measurement results over numerous screens is also possible. Cursor measurements with several cursor pairs and more than 40 scalar functions are available to measure trace parameters. An unlimited number of waveform math functions, such as arithmetic, smoothing and filter functions, can be applied to captured and pre-stored traces. More than 50 automatic math-on-math functions let a user simply carry out advanced analysis. The ability to document, analyze, store and import waveforms then print to a printer or a clipboard, rounds out the TransAS 3 software functions to provide an all-in-one, universal transient recorder solution. TraNET 14- and 16-bit systems with up to 240 MS/sec sampling rates offer a unique dual recording mode where fast events are digitized at a high speed, while a slower, related waveform is digitized simultaneously and shown in the same time frame. This useful feature is helpful in finding related phenomena, such as switching effects, on power lines, in EMP/EMI testing or in engine cadence testing. A further refinement supported by TransAS 3 is status logging. While recording data, a TTL marker signal (1 or 0) is displayed on screen indicating the status of a system or circuit under observation, such as a motor switching on or off. Each TraNET measurement channel has two marker inputs for easy correlation on observed effects and their potential external causes. For a limited time, a free copy of TransAS 3 that runs in simulation mode is available for those interested in learning more about this unique software package. For details and download, visit http://www.elsys-instruments.com.

Genedata Releases Patent Analysis Software Jointly Developed with DSM

Genedata, a leading provider of advanced software solutions for drug discovery and life science research, has announced the release of PatentExplorer, an interdisciplinary software tool for assessing the patent situation of novel biomolecules and targets. Part of the Genedata Phylosopher biological data management system, PatentExplorer integrates patent information to provide a comprehensive and structured analysis of patented biomolecule sequences, related claim information, and freedom-to-operate. This facilitates intellectual property evaluation from both a business and a biological standpoint. PatentExplorer was developed in close collaboration with DSM, a leading global life science company with major research programs in enzymes, nutrition, and biotechnology, to streamline DSM's global R&D activities. "Today's industrial biotechnology market is driven by innovation. Securing the intellectual property of life science research at DSM is crucial in order to retain a competitive advantage," explained Dr. Wim de Boer, Intellectual Assets Manager at DSM. "We chose Genedata to help us develop an integrated platform to manage our project intellectual property information because Genedata has significant scientific, technical and business experience and this has been a key factor in the success of this joint development project." "PatentExplorer integrates directly into DSM's global genome sequence information management system, which is based on the Genedata Phylosopher software platform," said Dr. Hans Roubos, Senior Scientist Bioinformatics at DSM. "It provides direct access to the most recent patent information in the context of DSM's in-house genomics research data, which gives much appreciated transparency to decision making." PatentExplorer's primary applications are in the development of novel enzymes and engineered proteins, as well as freedom-to-operate assessment support. The software can handle commercial data sources as well as publicly available patent information. For details, visit http://www.genedata.com.

Feds to Investigate Big Pharma’s Foreign Activities

As pharmaceutical companies expand their reach globally, the long arm of the U.S. justice and regulatory systems is advancing as well. Merck and SciClone have been contacted by the Justice Department and the SEC in a probe of illegal payments to foreign officials under the Foreign Corrupt Practices Act. Violations can include cash, gifts, meals, speaking fees or honoraria to foreign officials — including doctors, pharmacists, health ministry and custom officials — in exchange for favorable actions on a drug or device. For details, visit http://www.fda.gov.

FDA to Start Part 11 Inspections after Finding Compliance Issues

The FDA will begin inspections to determine companies’ compliance with electronic records guidelines under 21 CFR 11 (Part 11). The agency has seen a variety of compliance issues, ranging from insufficient computer system validation to missing audit trails, said George Smith, project manager officer in CDER’s Office of Compliance. Some of these issues may not have been obvious to industry since many citations were made to the predicate rule without Part 11 being mentioned, he added. For details, visit http://www.fda.gov.

FDA's Proposed Classwide Opioid REMS Rejected by Advisory Panel

A joint FDA advisory committee has rejected the agency's proposed classwide opioid risk evaluation and mitigation strategy (REMS) as lacking teeth. Saying the REMS did not do enough to prevent abuse, the agency's Anesthetic and Life Support Drugs and Drug Safety and Risk Management advisory committees voted 25–10 to reject the proposal. Committee members took issue with the FDA's decision not to include mandatory physician training and patient registration as part of the REMS and to have the program apply only to extended-release opioids. For details, visit http://www.fda.gov.

What's New - Right Now The following is a wrap-up of news of interest during the month of August 2010

What's New - Right Now
The following is a wrap-up of news of interest during the month of August 2010