The following is a wrap-up of news of interest during
the months of March to April 2003.Thermo to Showcase Latest Informatics Advances
at Achema 2003
Thermo Reveals Program for Barcelona Conference
on Laboratory Informatics
PerkinElmer LabWorks to be Highlighted at FWRC
LabVantage Attains Advanced Member Status in IBM
PartnerWorld for Developers Business Partner Program
Autoscribe's Matrix Stability Manager e-Book Introduces
Powerful Tools for Managing Stability Trials
Bio-Rad Announces Software for Advanced Proton
Prediction
Bio-Rad Announces Software Development & Distribution
System
Bio-ITWorld Awards "Best of Show" for
Knowledge Management and Collaboration to NuGenesis SDMS
Labtronics Ranks in Top 100 Canadian Software
Companies
New Software Provides Powerful Data Analysis Capabilities
for JEOL's AccuTOF LC/MS
ABB Optimizes Cement Production Process for Siam
Cement in Thailand
SDI Releases Global Survey of the Status and Prospects
of LIMS
SDI Publishes Eighth Annual Survey of LIMS in
North America: LABS ON LIMS 2003
FDA Says Bar Code Rule Doesn't Force Blister Packaging
ICH Guidance Outlines Electronic Information Transfer
FDA Promises Final Part 11 Guidance by July
FDA Releases Annual Guidance Agenda
InnaPhase Corporation Launches New Pharmaceutical
LIMS
InnaPhase Corporation Enters Strategic Partnership
with NuGenesis Technologies to Enhance Data Archival and Retrieval Within
the Pharmaceutical Industry
InnaPhase Corporation Selected By Biogen, Inc.to
Implement LIMS
CequeLogic Changes Company Name to Promium
StarLIMS' Web Based CRM Functionality Presented
at PITTCON 2003
IBM Life Sciences Signs Up StarLIMS
Thermo LabSystems and Thermo Galactic Rename to
Thermo Electron Corporation
Thermo LabSystems Releases New Brochure on Integrated
Informatics for Storage of Electronic Records
ATL's Sample Master Pro LIMS Now Offered in Bundle
with Toshiba Magnia Z310 Wireless Mobility Server
UBI and Ocimum Sign Distribution Agreement for
Bioinformatics Software in Canada
NuGenesis Technologies Launches Next-Generation
Platform for Managing Scientific Data
NuGenesis Technologies Announces Expanded Collaboration
and Co-Marketing Agreement with IBM
NuGenesis Technologies and LabWare Announce Enhanced
Integration Between LabWare LIMS and NuGenesis SDMS
NuGenesis Technologies Announces Double Digit
Revenue Increase in 2002
NuGenesis Technologies and FOSS NIRSystems Announce
New Compliance Integration Features
Nestle Selects NuGenesis Technologies to Deploy
Scientific Data Archival Solution
Scientific Software Announces New Software for
Knowledge Engineering
Swiss Interlabor Belp AG ImplementsScientific
Software's CyberLAB Knowledge Engineering System
Scientific Software Releases Version 3.1 of EZChrom
Elite Chromatography Data System
Scientific Software and Alltech Associates Sign
EZChrom EZStart Chromatography Software Agreement
Scientific Software Completes Record Sales Year
Labtronics Announces New Data Acquisition Software
for Pocket PC
Call for Input and Feedback on the Standards for
"The Quality Electronic Records Practices"
SDI Forecasts Instrument Industry to Grow at Over
8% in 2003
ABB to Deliver Industrial IT Solution and Electrification
to Greenfield Cement Plant in SR Vietnam
ABB, Accenture, Intel, Microsoft Align to Help
Manufacturers Connect Plant Operations to Enterprise Business Systems
New GMP Approach to Include Improved Dispute Resolution
FDA Plans Sweeping Changes to GMP Rules
New FDA Warning Letter System has Centers Performing
"Triage"
FDA May Apply Risk-Based Inspections to Supplement
Makers
Thermo to Showcase Latest Informatics Advances
at Achema 2003
The informatics business of Thermo Electron Corporation has announced that
a number of significant new software innovations will make their European
debut at ACHEMA 2003, May 19-24 on Booth #F13-H23 in Hall 6.3, Frankfurt
Am Main, Germany. ACHEMA attendees should note that the informatics business
of Thermo Electron was formerly doing business separately as Thermo LabSystems
and Thermo Galactic and will be exhibiting under its new identity for the
first time at ACHEMA. Thermo will be presenting the latest versions of its
two leading LIMS products, Nautilus and SampleManager, the eRecordManager
solution for long-term analytical data archival and knowledge management,
Atlas CDS (Chromatography Data System), and the GRAMS/AI desktop spectroscopy
product package. Through interfacing these systems to optimize automation
in the laboratory, Thermo claims to offer the most comprehensive, integrated,
single-vendor laboratory informatics solution available. For details, visit
the Thermo booth during ACHEMA or visit http://www.thermo.com/informatics.
Thermo Reveals Program for Barcelona Conference
on Laboratory Informatics
The informatics business of Thermo Electron Corporation has announced
the program for this year's European conference on laboratory informatics
and automation. Thermo Informatics World 2003 will take place at the Barcelo
Hotel Sants, Barcelona, Spain, 30 June-3 July. Formerly entitled Thermo
LabSystems World, the 2003 event features presentations from leading industry
users of Thermo's informatics solutions, with confirmed speakers to date
including Covance and Aventis. New for 2003 will be a product stream for
the award-winning eRecordManager solution and introductory presentations
of GRAMS A/I spectral data processing package. Following the merger with
sister business Thermo Galactic, Thermo has added desktop spectroscopy software
for data processing, data management, 3D data viewing, spectral reference
databases, and chemometrics to its informatics portfolio. As in previous
years, there will be language streams, presentations and breakout sessions
in French and Spanish, as well as English. For details, visit http://www.thermo.com/informatics/tiw.
PerkinElmer LabWorks to be Highlighted at FWRC
PerkinElmer will be highlighting their LabWorks LIMS solutions and hosting
a User Forum on NELAC during the upcoming FWRC Florida Water Resources Conference
to be held May 4-7 at the Tampa Convention Center in Tampa, FL The User
Forum will be held on May 8. Topics that will be covered include how NELAC
impacts laboratory practices and what role a LIMS need to play in compliance.
Those interested in attending can contact Angela Ray. For details, visit
http://www.perkinelmer.com or
http://www.fwrc.org.
LabVantage Attains Advanced Member Status in
IBM PartnerWorld for Developers Business Partner Program
LabVantage Solutions, Inc., a leading provider of Enterprise LIMS and Life
Sciences LIMS solutions, has announced that it has attained Advanced Member
status in IBM's PartnerWorld for Developers Business Partner Program. As
an Advanced Member of PartnerWorld for Developers, LabVantage gains further
access to a more comprehensive assortment of technical, informational, general
business, and marketing services. The expanded relationship positions LabVantage
moving forward to fully leverage IBM platforms, middleware, and computing
infrastructure capabilities. "Today, users of both Enterprise LIMS
and Life Sciences LIMS need to bring together large amounts of information
from disparate locations - often worldwide. This requires a robust computing
infrastructure that can be easily maintained and supported," said LabVantage's
CEO Jim Aurelio. "The expanding relationship with IBM further ensures
that LabVantage product offerings will be able to meet the continuing scalability
requirements of our global customers in Life Sciences and Enterprise LIMS."
For details, visit http://www.labvantage.com.
Autoscribe's Matrix Stability Manager e-Book
Introduces Powerful Tools for Managing Stability Trials
Autoscribe Ltd. has announced the first in a series of new topic information
packs based upon the highly intuitive e-book format. Using an abbreviated
PowerPoint-like presentation format, the e-book presents information on
Matrix Stability Management software that is concise, informative and readily
digestible. Developed for the management of stability trials in regulated
environments such as pharmaceuticals, food & beverage and consumer products,
Matrix Stability Manager uses a unique graphical tool for protocol design
which makes study set up easy and intuitive. Features within the product
include study and protocol design and approval, storage inventory calculations,
scheduling storage room operations (placements, cycles and pulls) and data
processing via LIMS. Built to easily migrate with the changing needs of
a business, Matrix Stability Manager configuration tools allow appropriately
authorised users to modify or create screens, menus and reports to suit
individual end-user requirements. Matrix Stability Management software operates
with Autoscribe Matrix Plus or any other LIMS. Copies of Matrix Stability
Manager e-book are available on disk direct from Autoscribe or as a downloadable
file from http://www.autoscribe.co.uk/stabilitymanager.htm.
Bio-Rad Announces Software for Advanced Proton
Prediction
Bio-Rad Laboratories, Inc., a multinational manufacturer and distributor
of life science research products and clinical diagnostics, has announced
the newest addition to its KnowItAll Informatics System Product Line, Model
It HNMR for advanced proton NMR prediction and simulation. Model It HNMR
is the first proton NMR (HNMR) prediction software based on a molecular
modeling approach and the calculation of conformers in solution, and is
the result of Bio-Rad's ongoing collaboration with PERCH Solutions, Ltd.
This unique application generates predicted proton spectrum from a chemical
structure and considers factors beyond those that current proton NMR prediction
packages on the market address. Unlike other prediction software, Model
It HNMR also examines the effects of the stereochemistry, intra-molecular
interactions, and solvent effects. By incorporating these variables into
the mathematical model, chemical shifts can be predicted with greater accuracy.
A complex model optimizes structures in three-dimensional space, performs
Monte-Carlo analysis to generate a statistical set of conformers, and considers
the effects of the solvent. The software can automatically differentiate
between equivalent and nonequivalent protons based on the symmetry of the
structure, and the user has the ability to modify these assignments. For
details, visit http://www.bio-rad.com.
Bio-Rad Announces Software Development &
Distribution System
Bio-Rad Laboratories,Inc. has announced its Bio-Rad Informatics' KnowItAll
Software Development & Distribution Program. With the launch of this
program, Bio-Rad's Informatics Division formally invites software and database
developers worldwide to apply for possible inclusion of their products within
Bio-Rad's unique KnowItAll software environment if they see a potential
fit. Bio-Rad's KnowItAll Informatics System offers a fully integrated environment
for cheminformatics and multiple analytical techniques, such as NMR, IR,
MS, Raman, GC, and NIR, and drug discovery. The structure of this environment
is unique in that it is designed so the user can easily transfer data from
application to application without having to leave the main interface or
open another program. As laboratory needs change and grow, this open architecture
also allows for the addition of new software from Bio-Rad or third party
providers. The KnowItAll Software Developer's Kit (SDK), created last year,
offers the ability to add new software applications to the KnowItAll software
environment that are fully integrated. For details, visit http://www.bio-rad.com.
Bio-ITWorld Awards "Best of Show"
for Knowledge Management and Collaboration to NuGenesis SDMS
NuGenesis Technologies Corporation was honored with a "Best of Show"
Award at a ceremony held in conjunction with the Spring Bio-ITWorld Conference
& Expo held in early April in Boston. NuGenesis Technologies was selected
for an "innovative technology product that helps accelerate and streamline
the drug discovery and development process." A panel of judges led
by Bio-IT World editors, which included technology end-users in life sciences
research organizations, chose "Best of Show" award winners based
on technical merit, functionality and innovation. The NuGenesis Scientific
Data Management System (SDMS) was selected in the Knowledge Management and
Collaboration category. The Web-based platform of NuGenesis SDMS utilizes
application independent architecture that enables research members and managers
to unify, share and fully reutilize scientific data generated from the vast
array of laboratory data sources on a global basis. It provides the seamless
integration of all data sources within the existing IT infrastructure in
the lab, with the ability to exchange data with other common systems and
"niche" software tools such as statistics and visualization programs.
For details, visit http://www.nugenesis.com.
Labtronics Ranks in Top 100 Canadian Software
Companies
Labtronics Inc., a leading developer of laboratory instrument interfacing
software has jumped up 11 positions in the 2002 Branham Group annual listing
of the top 100 software companies in Canada. The prestigious Branham listing
ranks Canadian software companies based on total revenue for the calendar
year. Labtronics' rise in the Top 100 reflects a substantial 17% increase
in revenues achieved in 2002. For details, visit http://www.labtronics.com.
New Software Provides Powerful Data Analysis
Capabilities for JEOL's AccuTOF LC/MS
JEOL USA Inc has developed a new data analysis software package for
the AccuTOF time-of-flight mass spectrometer that identifies components
in complex mixtures such as peptide digests. The new software was developed
for Dr. W. V. Ligon and H. Grade at GE Global Research, Niskayuna, New York.
It identifies individual components present in partially overlapping chromatographic
peaks and isolates the high-resolution mass spectra for each component.
By combining this software with the automatic function switching capability
in AccuTOF's Mass Center software, one can obtain both molecular
weight information and fragment ion information from each component in a
single analysis. The exact masses are preserved for both molecular species
and fragments. This provides MS/MS-like capabilities that allow the operator
to assign elemental compositions to the intact molecule and its fragments.
This makes it easier to assign structures and provides greatly improved
reliability for library and protein database searches. For details, visit
http://www.jeol.com.
ABB Optimizes Cement Production Process for
Siam Cement in Thailand
ABB, a leading power and automation technology group, has announced
that three contracts were signed to supply Optimize IT Expert Optimizer
to the Siam Cement Plants of Kaeng Khoi as well as an extension to Khao
Wong. The new contracts follow successful implementation of two expert systems
supplied last year to Siam Cement. 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 a "super"
cement plant operator and implements them on-line in the manner of an auto-pilot.
The main benefits that Siam Cement expect sto achieve include increased
cement output, lower fuel consumption and extended cement kiln refractory
life, at the same time reaching better and more consistent cement quality.
Lower plant maintenance costs will result from improved run-times. For details,
visit http://www.ch.abb.com.
SDI Releases Global Survey of the Status and
Prospects of LIMS
Published in March 2003, SDi's Tactical Sales and Marketing (TSM) report,
"A Global Survey of the Status and Prospects of the Laboratory Information
Management Systems (LIMS)" provides invaluable insights into the LIMS
marketplace. Data is presented by industry, vendor, and concurrent users.
Each section includes a list of key observations, important implications,
and suggested actions to assist in the implementation of changes. The report
also details how LIMS products are distributed by laboratory focus and function,
and paints a clear picture of the different needs and views of each geographic
and industrial segment of the market. The information for this report is
based on a survey of 515 LIMS end-users from all over the world conducted
during 2002. The report costs $4895. For details, visit http://www.strategic-directions.com.
SDI Publishes Eighth Annual Survey of LIMS
in North America: LABS ON LIMS 2003
In this report, published by Strategic Directions International, Inc.,
end-users share their views and experiences regarding their current LIMS.
In a market with such an expanding number of products and suppliers, users
must be able to discern the actual advantages and disadvantages of particular
systems and suppliers. Labs on LIMS 2003 is specifically designed for end-users
and for the prospective LIMS buyer. Topics addressed in this study include
LIMS system type, hardware platforms, operating system, database management,
instrument interfacing, duration of installation, service contracts, and
supplier and product evaluations. Where appropriate, data is presented separately
for less than or equal to 20 concurrent users and greater than 21 concurrent
users. Respondents have evaluated these suppliers on 20 different performance
factors and rated products on an additional 22 different product features
and functions. Information for this report is based on a survey of 320 North
American LIMS end-users conducted during the 2nd half of 2002. The report
costs $495.00. For details, visit http://www.strategic-directions.com.
FDA Says Bar Code Rule Doesn't Force Blister
Packaging
A proposed rule calling for bar codes on drugs is not intended to induce
manufacturers to package their solid-dosage form products in unit-dose blister
packs, according to Mary Gross, a senior policy analyst in the Office of
Drug Safety at FDA's Center for Drug Evaluation and Research. Gross spoke
last week at a meeting on bar code strategies in Washington, D.C., sponsored
by the Institute for International Research. To see the proposed rule, published
in mid-March, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/03-5205.pdf.
ICH Guidance Outlines Electronic Information
Transfer
In an effort to help drug companies electronically submit marketing applications,
the FDA released guidance prepared by the International Conference on Harmonization.
The electronic common technical document guidance describes how industry
should transfer regulatory information to agencies electronically. To see
the guidance, published April 2, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/01d-0435-gdl0003.pdf.
FDA Promises Final Part 11 Guidance by July
The much-awaited final 21 CFR Part 11 guidance will be released within three
months, an FDA official says. Joe Famulare, director of the Division of
Manufacturing and Product Quality, said the agency expects to issue the
guidance no later than 60 days after the April 30 deadline for comments
on the withdrawal of prior Part 11 guidances. The FDA wants a quick turnaround
and has promised a narrower interpretation of the rule, said Famulare, leader
of the FDA's subgroup on Part 11. "Ideally, we'd issue it 30 days after
[the April 30 closing date], but that's pretty aggressive," he said
in an exclusive interview this week. For details, visit http://www.fda.gov.
FDA Releases Annual Guidance Agenda
The FDA has published its annual guidance agenda document, which lists guidances
that the agency plans to develop or revise during the coming year. The agency
is seeking public comments on the list. To see the Federal Register
notice about the agenda, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/03-8262.pdf.
InnaPhase Corporation Launches New Pharmaceutical
LIMS
InnaPhase Corporation introduced the Pharma LIMS(TM) Suite at the 2003 Pittsburgh
Conference held in Orlando, Florida on March 9-14, 2003. The Pharma LIMS
Suite is a series of purpose-built LIMS solutions for the pharmaceutical
industry and was designed to operate in a 21 CFR Part 11 compliant environment.
The solutions within the Suite include: Newton LIMS for batch release, quality
control, formulation, stability and analytical development; Watson LIMS
for pre-clinical and clinical bioanalysis; and Galileo LIMS for In Vitro
testing. For details, visit http://www.innaphase.com.
InnaPhase Corporation Enters Strategic Partnership
with NuGenesis Technologies to Enhance Data Archival and Retrieval Within
the Pharmaceutical Industry
InnaPhase Corporation has announced their partnership agreement and technology
alliance with NuGenesis Technologies, developers of scientific data management
systems. This partnership will assist pharmaceutical and biotechnology professionals
in the development of more effective drugs by integrating the NuGenesis'
Scientific Data Management System (SDMS) with each of the software solutions
within the InnaPhase Pharma LIMS Suite. The Pharma LIMS Suite is a LIMS
solution for the pharmaceutical industry and includes: Newton LIMS for batch
release, quality control, formulation, stability and analytical development;
Watson LIMS for pre-clinical and clinical bioanalysis; and Galileo LIMS
for In Vitro testing. The NuGenesis SDMS is an application-independent,
web-enabled platform for the automated collection, storage and management
of scientific information direct from the data sources (instruments and
office applications). NuGenesis SDMS provides scientists with immediate,
easy access to data from their own lab or another facility anywhere in the
world. For details, visit http://www.nugenesis.com
or http://www.innaphase.com.
InnaPhase Corporation Selected By Biogen, Inc.to
Implement LIMS
InnaPhase Corporation has announced that Biogen Inc., the world's oldest
independent biotechnology company, has signed a license agreement to implement
InnaPhase's Watson LIMS. This most recent agreement provides Biogen, Inc.
with Watson licenses for their Cambridge, Massachusetts and Research Triangle
Park, North Carolina facilities in the United States.Watson LIMS, a solution
within the Pharma LIMS Suite, is specifically designed to support DMPK/Bioanalytical
studies in drug development while ensuring regulatory compliance with the
FDA's 21 CFR Part 11 guidance on electronic records and signatures. Watson
has an established track record of accelerating bioanalysis, sample management
and regulatory compliance in pharmaceutical drug development. For details,
visit http://www.innaphase.com.
CequeLogic Changes Company Name to Promium
Promium is the new name for CequeLogic, LLC. The company believes that
the new name better conveys the professionalism and efficiency that their
products bring to the environmental testing laboratory. Promium develops
the Element DataSystem LIMS solution, which is installed in more than 50
laboratories and used by more than 1500 lab professionals.Element DataSystem
allows users to import from Forms II Lite sample data collection software
and report results in Superfund Electronic Data Deliverable (SEDD) format.
EPA laboratories in Regions 5, 6, and 9 use Element DataSystem to meet their
laboratory information management needs. For details, visit http://www.promium.com.
StarLIMS' Web Based CRM Functionality Presented
at PITTCON 2003
When installed in a web setting, StarLIMS new CRM module directly coupled
with the StarLIMS database allows the lab's clients to view analytical services
provided by the lab, such as tests and price lists, view samples status,
print COAs, invoices and more. For details, visit http://www.starlims.com/CRM.htm.
IBM Life Sciences Signs Up StarLIMS
L.i.M.S. and IBM announced that they have entered into a collaboration agreement
to deliver a set of integrated applications and services for analyzing,
managing and storing laboratory data within the life sciences industry.
For details, visit http://www.starlims.com/IBM.htm.
Thermo LabSystems and Thermo Galactic Rename
to Thermo Electron Corporation
Thermo LabSystems and Thermo Galactic, Thermo Electron businesses and
market leaders in laboratory informatics solutions, have announced that,
with immediate effect and in line with the current Thermo Electron integration
strategy, the LabSystems and Galactic names will cease to exist and the
informatics business of Thermo Electron will trade simply as Thermo Electron
Corporation. The combined informatics organization made its public debut
under its new identity at 2003. This change brings together the skills and
resources of two leading vendors in the global laboratory informatics marketplace.
Expertise in the development and support of desktop spectroscopy systems
is combining with an impressive track record in LIMS (Laboratory Information
Management Systems), CDS (Chromatography Data Systems) and solutions for
long term data archival. Development, support and marketing of Thermo's
leading informatics products brands, including SampleManager LIMS, Nautilus
LIMS, Atlas CDS (Chromatography Data System), eRecordManager data archival
and knowledge management solution, and GRAMS A/I spectral data processing
product will continue to be managed from the Altrincham, UK and Salem, New
Hampshire facilities. For details, visit http://www.thermolabsystems.com.
Thermo LabSystems Releases New Brochure on
Integrated Informatics for Storage of Electronic Records
Thermo LabSystems has announced the availability of a brochure outlining
a new software solution, which has resulted from its collaborative product
integration project with IBM Life Sciences. The brochure describes the comprehensive
enterprise-wide hierarchical storage solution that has been developed through
the integration of Thermo's eRecordManager analytical data archival system
with IBM's Tivoli Storage Manager. The new brochure presents an overview
of business and regulatory challenges confronting science-based industry
that are associated with long term storage and retrieval of analytical data
as electronic records. Thermo describes how the combined solution offers
an end-to-end solution from the receipt and normalization of the original
instrument raw data, through indexing for ease of searching, to storage
on, and migration to, appropriate media. For details, visit http://www.thermolabsystems.com.
ATL's Sample Master Pro LIMS Now Offered in
Bundle with Toshiba Magnia Z310 Wireless Mobility Server
Accelerated Technology Laboratories Inc's (ATL) has announced that its Sample
Master Pro LIMS is now available bundled on the Toshiba Magnia Z310 Wireless
Mobility Server. Toshiba's Magnia Z310 is designed to provide users with
an affordable, easy to deploy wireless network solution while the addition
of ATL's software also allows time critical access to laboratory data. Wireless
Tablet PCs, such as the Toshiba Portégé 3500 convertible Tablet
PC, are ideal client companions to this solution. For instance, the tablet
PC and turnkey server solution allow those in the laboratory extra mobility
from the workbench to the office or meeting room, with instant access to
their data. The server is cost effective, portable, and wireless which allows
secure access from various locations in the building, along with the ability
of those in the laboratory to share faxes, a printer and the Internet. This
all-in-one turnkey solution will result in a product offering that will
enhance ATL's clients' ability to accelerate their data collection, add
hand written notes or drawings to samples and provide mobility outside of
the laboratory. For details, visit http://www.atlab.com.
UBI and Ocimum Sign Distribution Agreement
for Bioinformatics Software in Canada
United Bioinformatica Inc. (UBI), a leading distributor of bioinformatics
software in Canada and Ocimum Biosolutions (Ocimum) have announced that
they have completed a distribution agreement for: Genchek - a comprehensive
multi-platform Sequence Analysis software package that facilitates analysis
of Expressed Sequence Tags (ESTs), Complete Genome, and SNP (Single Nucleotide
Polymorphism) data and Biotracker - a LIMS for improving laboratory performance.
"Genchek is the only commercial desktop sequence analysis software
with a modern database (MySQL), written in the industry standard Java language,
that is priced right for the academic market," said Lindsay Moir, President
of UBI. Moir also stated that "Biotracker is the most cost effective
and comprehensive LIMS system for the emerging Biotech Company that needs
to manage its laboratory personnel and facilities better as it drives towards
commercialization of its drug discovery targets." Subash Lingareddy,
President of Ocimum said, "UBI is a proven leader in selling bioinformatics
products in Canada. UBI has a great understanding of the diverse needs of
the scientific community in Canada and we hope to deliver cutting edge solutions
through them. For details, visit http://www.ocimumbio.com
or http://www.ubi.ca.
NuGenesis Technologies Launches Next-Generation
Platform for Managing Scientific Data
NuGenesis Technologies has announced the launch of the next generation of
its NuGenesis Scientific Data Management System (SDMS), NuGenesis SDMS 6.
Version 6 offers significant new features, including a single new user interface;
a web-based platform that integrates within existing technology without
disrupting current systems; automated archival and audit trail capabilities
for security and compliance; scalable architecture that enables deployment
at the lab level or the global enterprise level, ane more. For details,
visit http://www.nugenesis.com.
NuGenesis Technologies Announces Expanded Collaboration
and Co-Marketing Agreement with IBM
NuGenesis Technologies Corporation has announced an agreement with IBM to
co-market the NuGenesis Scientific Data Management System (SDMS) with IBM
eServer and TotalStorage solutions. The combined offering is designed to
help life sciences companies, including drug makers, access and utilize
research data more effectively within their global life sciences enterprises
and throughout the drug discovery, development and manufacturing cycles.
NuGenesis SDMS is an application-independent, Web-based platform that captures
and securely stores all the raw analytical and report data from existing
instruments, as well as other software applications, using IBM storage and
server solutions. NuGenesis SDMS integrates with IBM's Tivoli Storage Manager
to offer data protection from hardware failures and other errors, so that
customers can achieve long-term data preservation, intellectual property
protection, and overall cost management in compliance with the Food &
Drug Administration's 21 CFR Part 11 requirements for electronic recordkeeping.
To better quantify the data archiving and storage capabilities of the NuGenesis
SDMS running on IBM equipment, performance and scalability testing were
recently performed at the IBM Solution Partnership Center in Waltham, MA.
In seven days of continuous operation 9.75TB (terabytes) of data were successfully
archived onto an IBM Enterprise Storage Server(R)(code-named Shark) - representing
2,022,712 files of 5MB (megabytes) each. This is equivalent to the size
of the entire printed collection of the U.S. Library of Congress. When extrapolated
to one year, the NuGenesis SDMS/IBM solution provides the capability to
archive 527TB of data, or 110 million files. White paper with details available
at http://www.nugenesis.com/_files/wp_perf_test/.
For details, visit http://www.nugenesis.com.
NuGenesis Technologies and LabWare Announce
Enhanced Integration Between LabWare LIMS and NuGenesis SDMS
NuGenesis Technologies Corporation and LabWare have announced enhanced technology
integration in support of a paperless laboratory environment. LabWare has
developed an Electronic Analytical Worksheet that directly ties into its
LIMS and also provides instant access to supporting information stored in
the NuGenesis Scientific Data Management System (SDMS). Customers can now
create worksheets that include selected and derived results from LIMS as
well as complete records from NuGenesis SDMS, with graphical elements. For
details, visit http://www.nugenesis.com
or http://www.labware.com.
NuGenesis Technologies Announces Double Digit
Revenue Increase in 2002
NuGenesis Technologies has announced a strong double digit revenue increase
in 2002 and that the company met its goal of turning cash flow positive.
Leading pharmaceutical, biotechnology and chemical companies have invested
$60 million to date in the NuGenesis Scientific Data Management System (SDMS),
with nine customers spending over $1.5 million each on NuGenesis SDMS technology.
The Company reports that 65% of total sales are to existing customers looking
to expand current installations. More than 30,000 users in over 500 laboratories
around the world now use NuGenesis SDMS. For details, visit http://www.nugenesis.com.
NuGenesis Technologies and FOSS NIRSystems
Announce New Compliance Integration Features
NuGenesis Technologies Corporation, a market leader in scientific data management,
and FOSS, a market leader in pharmaceutical NIR analysis, have announced
new compliance integration features that provide customers using the NuGenesis
Scientific Data Management System (SDMS) and FOSS NIR Analyzers with enhanced
automated software tools for secure data archival, retrieval and reuse.
The NuGenesis Scientific Data Management System (SDMS) is an application-independent,
Web-based platform that uses unique technology to capture and securely store
all the raw analytical and report data from existing instruments as well
as other software applications. FOSS' Vision software utilizes Extensible
Markup Language (XML) and combines NuGenesis "per file template"
technology to create an XML catalog file that describes the content of archive
unit records - flat file back up files. The archive units created by FOSS
Vision are automatically captured by NuGenesis SDMS, which extracts up to
75 tags (content) from the associated catalog file. The printed reports
with information for analysis and decision-making by end users are also
automatically captured by NuGenesis SDMS, and their content indexed so as
to be searchable and re-useable in other applications. For details, visit
http://www.nugenesis.com or http://www.foss.dk.
Nestle Selects NuGenesis Technologies to Deploy
Scientific Data Archival Solution
After a successful pilot, Nestle will implement the NuGenesis Scientific
Data Management System (SDMS) as its scientific archiving and back-up solution
for their Research Centre in Lausanne, Switzerland. The NuGenesis SDMS will
provide a centrally managed archiving system for raw data from the many
diverse scientific instruments in the lab. The solution will be further
evaluated for other Nestle R&D centers in 2003. "The successful
completion of this trial confirms NuGenesisí leadership in long-term
archival and restoration of scientific data from a wide range of analytical
instruments," said Peter van Bladeren, Head of the Nestle Research
Center. "NuGenesis Technologies has provided a scalable, easily deployable
solution for data archival, storage and management." For details, visit
http://www.nugenesis.com.
Scientific Software Announces New Software
for Knowledge Engineering
Scientific Software, Inc. has announced the introduction of several new
software products that will
significantly enhance the usability of laboratory data. CyberLAB ReportManager,
CyberLAB Analytics, and CyberLAB KnowledgeMiner Suite allow users to report,
visualize, analyze, mine and extract meaningful knowledge from the growing
mountain of data being generated by life sciences organizations. Users can
easily drill through, report, mine and visualize very large data stores.
In addition, these thin-client web-based products can integrate data from
the Company's CyberLAB Knowledge Engineering System with data from other
sources, such as LIMS or document management systems. These new products
are available for immediate shipment. For details, visit http://www.scisw.com.
Swiss Interlabor Belp AG Implements Scientific
Software's CyberLAB Knowledge Engineering System
Scientific Software Inc. has announced that the Interlabor Belp AG, located
in Belp, Switzerland, is implementing Scientific Software's CyberLAB Knowledge
Engineering System. CyberLAB allows Interlabor to create an electronic document
management system and assists in achieving the 21 CFR Part 11 and predicate
GMP requirements for electronic records and electronic signatures. CyberLAB
will store all raw data derived from analytical instruments and capture
the print-outs in the industry standard Portable Document Format (PDF).
CyberLAB Knowledge Engineering System is a web-based system designed to
capture and maintain all the electronic records across the enterprise. Users
can search, retrieve, and archive any type of an electronic record of any
size. Designed with U.S. 21 CFR Part 11 in mind, CyberLAB assists organizations
to become compliant with this new regulation. Built using standard web technology,
CyberLAB is expandable from single user system to global multi-site implementations.
For details, visit http://www.scisw.com.
Scientific Software Releases Version 3.1 of
EZChrom Elite Chromatography Data System
Scientific Software, Inc. has released version 3.1 of its EZChrom Elite
Chromatography Data System. EZChrom Elite version 3.1 provides new advances
for chromatography data handling, including improved system security, audit
trails and traceability for the Enterprise environment; new instrument control
of the Hitachi LaChrom Elite HPLC instruments, Varian CP-4900 MicroGC, and
more; improved batch electronic signature support to facilitate rapid electronic
review of results in accordance with FDA's 21CFR Part 11 guidelines; and,
networking all instruments via Scientific Software's OpenLAB iCON XP. Version
3.1 of EZChrom Elite can be deployed in stand-alone, thin client, or client/server
computing environments. The software supports Windows XP, Windows 2000,
and Windows NT operating systems and is available immediately. For details,
visit http://www.scisw.com.
Scientific Software and Alltech Associates
Sign EZChrom EZStart Chromatography Software Agreement
Scientific Software, Inc. has announced that Alltech Associates has signed
a non-exclusive distribution agreement of Scientific Software's new EZChrom
EZStart software. Alltech Associates is a leading supplier of chromatography
products. With a network of more than 65 distributors and dealers, Alltech
manufactures and distributes an extensive line of columns for HPLC, GC,
IC, TLC, SPE, and sample handling. Under the terms of the agreement, Alltech
Associates can market the new EZStart chromatography software through its
sales and distribution channels. Each EZStart Software Package includes
software control of the LC or GC instrument as well as data acquisition,
data processing, postrun analysis, and reporting. Software wizards are provided
to guide users to create methods and sequences quickly and easily. EZStart
Software includes many powerful features such as integration on the fly
and the exclusive "SmartSequence" that can generate conditional
actions and decisions while running sequences in an automated, unattended
mode. For details, visit http://www.scisw.com.
Scientific Software Completes Record Sales
Year
Scientific Software, Inc. has announced that they have completed fiscal
2002 with record sales of its
industry leading CyberLAB Knowledge Engineering System, EZChrom Elite Chromatography
Data System and related consulting services. The company enjoyed strong
double-digit sales growth over the previous fiscal year. In 2002, several
top 10 pharmaceutical companies standardized globally on CyberLAB to improve
compliance with 21 CFR Part 11 and to facilitate data archiving and knowledge
management. Several thousand additional CyberLAB users from leading pharmaceutical,
biotechnology and contract research organization were added to the expanding
list of companies that utilize CyberLAB to improve time to market for new
compounds and to manage the growing life sciences data explosion. Significant
new partnerships from such companies as EMC Corporation, Agilent Technologies
and Covex LLC were developed during the year to offer complete solutions
to customer data management challenges. For details, visit http://www.scisw.com.
Labtronics Announces New Data Acquisition Software
for Pocket PC
Labtronics Inc. has released a new version of Collect CE, data acquisition
software for lab instruments. With this new release Collect CE now supports
the Pocket PC 2002 operating system. Collect CE collects instrument data
into any Pocket PC application. Collect CE is ideal for interfacing instruments
such as pH meters, bar-code readers, force gauges, digital calipers and
spectrophotometers. Features include: store multiple instrument setups;
example configurations for common instruments; collect data directly into
Pocket Excel or any other Pocket PC application; transfer work lists or
other sample information from a central PC; control cursor movement within
applications; and support for multiple COM ports. For details, visit http://www.labtronics.com.
Call for Input and Feedback on the Standards
for "The Quality Electronic Records Practices"
The Global Electronic Records Association (GERA) has released for feedback
The Quality Electronic Records Practices that focus on designing, validating,
legal defense, and auditing of electronic evidence in documentary form that
is of high economic, high legal or regulatory consequence, or high historical
value. The focus is on the entire lifespan of electronic records and
their long-term preservation and access for many decades, centuries, or
perhaps permanently. The US National Archives & Records Administration's
(http://www.archives.gov/) National Historical Publications & Records
Commission (NHPRC) and the Collaborative Electronic Notebook Systems Association
(http://www.censa.org/) have jointly funded the Quality Electronic Records
Practices (QERPs) standard specifications and guides. The first three QERPs
Specifications and Guidelines are available for public input and feedback
now.
The Quality Electronic Records Practices (QERPs) standards include the foundation
document, the Electronic Records Lifecycle Specification (ERLS) that identifies
and details all required design elements in an organizational program to
capture and manage electronic records over their entire lifespan; the QERPs
Validation Guide that is designed to help any government or industrial organization
validate and verify all required elements of a Quality Electronic Records
Program and its technology components and systems; and, the Legal Acceptability
Guide for Electronic Records (LAGER) Version 1, for resolving legal and
evidentiary issues on electronic records. GERA requests your participation!
Please register for free access at http://www.erecordscentral.org/gera_register.htm.
SDI Forecasts Instrument Industry to Grow at
Over 8% in 2003
The analytical and life science instrument industry is forecasted to grow
at a rate of 8.4% in 2003, according to the latest data released from Strategic
Directions International (SDi), a market research and consulting firm that
tracks the instrument industry. The forecast appears in the January 15th
edition of Instrument Business Outlook (IBO). The market for analytical
and life science instruments, which are used in life science research, laboratory
testing and other scientific and industrial applications, grew an estimated
8.2% in 2001 to over $24 billion, according to the report in IBO. The special
12-page January 15th issue of IBO features detailed 2003 forecasts by technique
for all analytical and life science instrument segments. Among the instrument
segments estimated to register strong growth in 2003 are mass spectrometry
and bioinstrumentation, including microarrays and bioinformatics. Traditional
analytical techniques, such as Raman spectroscopy, calorimetry and solvent
extraction, should also experience healthy growth due to demand from a range
of end-user markets. Analytical and life science instrument segments covered
in the IBO forecast: Liquid Phase Instrumentation; Bioinstrumentation; Mass
Spectrometry; Lab Automation; Gas Phase Instrumentation; Atomic Spectroscopy;
Molecular Spectroscopy; Surface Science Techniques; Physical Property Instrumentation;
and "Other " Analytical Techniques. For details, visit http://www.strategic-directions.com.
ABB to Deliver Industrial IT Solution and Electrification
to Greenfield Cement Plant in SR Vietnam
ABB, a leading power and automation technology group, has been awarded
a contract to supply an Industrial IT technology solution and electrification
to Midlands new Song Gianh Cement Plant, being constructed in the Quang
Binh province of SR Vietnam. ABB will deliver the complete electrical and
automation equipment, engineering, design, training, supervision and commissioning
for the total cement plant. The scope of supply includes power distribution,
DriveIT medium and low voltage motors and drives, OperateIT control systems
and OptimizeIT optimization systems as well as communication and instrumentation
systems. The delivery for the infrastructure comprises cables, lighting,
earthing and lightning protection and the fire detection system. The Song
Gianh cement plant will have a production capacity of 4,000 tons of clinker
per day. The production start is planned for 2005. TFor details, visit http://www.abb.com.
ABB, Accenture, Intel, Microsoft Align to Help
Manufacturers Connect Plant Operations to Enterprise Business Systems
ABB, Accenture, Intel Corporation and Microsoft Corp. have announced an
alliance to help manufacturers bridge the gap between plant floor operations
and enterprise IT systems. The alliance aims to help manufacturers by simplifying
integration, gaining greater visibility into their businesses, making informed,
real-time business decisions and enhancing their financial performance.
The four companies will provide a full range of computing diagnostics, solution
design, development and integration services for manufacturers. The team's
joint development work will help customers gain access to manufacturing
automation technology that will work seamlessly in a plant environment and
integrate with a wide collection of enterprise IT systems. The collective
resources of the alliance members bring automation and power products, manufacturing
solution expertise, robust computing and networking, and program management
and integration skills together to support a powerful open architecture
for enterprise solutions. For details, visit http://www.abb.com.
New GMP Approach to Include Improved Dispute
Resolution
As part of its broad GMP initiative update in February 2003, the FDA
has proposed a three-tiered dispute resolution process to deal with disagreements
over inspection results. Under the first stage of the proposal, an informal
process would try to resolve disputes before an inspector issues a Form
483, or Notice of Inspectional Observations. Manufacturers would be encouraged
to challenge findings they believe are not justified by science, and inspectors
would seek clarification from their district office or relevant program
center. The FDA plans to initiate the program as a 12-month pilot. For more
information, see the FDA's Dispute Resolution Working Group's new report
at http://www.fda.gov/cder/gmp/gmpdispute.htm.
FDA Plans Sweeping Changes to GMP Rules
The FDA has announced yet another set of initiatives to take the agency
closer to its goal of creating a risk-based approach to good manufacturing
practices (GMPs) for drug companies. The FDA plans to have a more detailed
risk model in place by fiscal 2004 that will help the agency predict where
its inspections would most likely have the greatest impact, Center for Drug
Evaluation and Research Director Janet Woodcock said at a teleconference
yesterday unveiling the plan. For details, visit http://www.fda.gov/cder/gmp/index.htm.
New FDA Warning Letter System has Centers Performing
"Triage"
The FDA plans a "triage procedure" for its centers to handle
proposed warning letters on good manufacturing practice (GMP) violations,
Center for Drug Evaluation and Research (CDER) Director Janet Woodcock said.
As of March 1, district offices will propose warning letters to the FDA's
program centers, which will review them for consistency, according to Fred
Blumenschein, chief of CDER's Case Management and Guidance Branch in the
Division of Manufacturing and Product Quality. The agency announced last
week that it was shifting the authority for GMP warning letters from district
offices to the centers as part of its overall GMP initiative. For details,
visit http://www.fda.gov/cder/gmp/gmp_q&a.htm.
FDA May Apply Risk-Based Inspections to Supplement
Makers
The FDA plans to focus its inspection efforts on supplement companies
at greatest risk for good manufacturing practice (GMP) problems, a strategy
that appears similar to the risk-based approach the agency is taking for
drugs. The agency will publish the proposed rule for dietary supplement
GMPs March 13. Comments are due June 11. For details, visit http://www.fda.gov/OHRMS/DOCKETS/98fr/96n-0417-npr0001-01.pdf.