The following is a wrap-up of news of interest during
the months of November to December 2002.Laboratory Informatics 2003 to be Held at Pittcon
New AIS Prescheduling Module Manages Stability
Trials And Result Quality In the Pharmaceutical and Food Industries
Chinese Content Pages Now Available on StarLIMS.com
Agaram to Introduce StarLIMS to the Indian Market
Food Safety Net Services, Ltd. Selects LabVantage
for Next Generation Enterprise Quality Management LIMS
CREON.LAB.CONTROL Expands Presence In Eastern
Europe
InnaPhase Corporation Announces New Chief Executive
Officer and New Product Offering Scheduled for Release in 2003
Thermo Electron Names Marijn E. Dekkers CEO; Richard
F. Syron to Serve as Full-Time Executive Chairman
Latest Informatics Advances to be Showcased by
Thermo LabSystems at Pittcon 2003
Thermo Presents Latest Informatics Solutions at
Bio-ITWorld 2003
Scimcon and LabVantage Solutions Form Strategic
Business Agreement
Paperless Laboratories Will Encourage Collaboration
According to a Poll by NuGenesis Technologies
NuGenesis Announces New Interface for NuGenesis
SDMS and Labcon NuConnect
Zymark Introduces Easy-to-Use Software for Linking
Laboratory Instruments
McClellan Pledges Shorter Drug Reviews
GAO Criticizes Lengthy FDA Drug Ad Reviews
Device and Diagnostics Manufacturers Will Need
Different Quality Systems for U.S. and International Markets
FDA Releases Books to Facilitate Surviving GMP
Inspections
FDA Releases Books on How to Design and Conduct
of Clinical Trials
FDA Book Helps Prepare for Requirements of Adverse
Event Reporting
FDA Plans Tougher Dietary Supplement Oversight
Thermo LabSystems Introduces Enhanced LIMS Functionality
for Analytical Quality Control in Nautilus 2002 R3
LabVantage Sapphire Selected by WestFarm Foods
to Help Reduce Operating Costs and Improve Customer Service
Agilent Technologies Ships Revision of Cerity
Networked Data Systems for Pharmaceutical QA/QC
Agilent Technologies' President and CEO to Assume
Board Chairmanship
Agilent Technologies Reports Fourth Quarter Results
at Breakeven
Scientific Software Launches New Customer Support
Forum
Scientific Software Introduces Novel Device for
Instrument Control and Data Acquisition
FDA to Open Combination Products Office by December
25
McClellan Says Reviews Must Keep Up with Scientific
Advances
Part 11 Draft Guidance Adds New Scope to FDA
Scrutiny of E-records
Recommendations in Part 11 Guide Raise Industry
Concerns
PerkinElmer's New LABWORKS ES LIMS Streamlines
Key Business Processes
PerkinElmer Launches New Microarray Informatics
Platform
PerkinElmer Forms Life and Analytical Sciences
Organization
PerkinElmer Extends 21 CFR Part 11 Compliance
For FT-IR Analyses in the Pharmaceutical Industry
PerkinElmer Reports Third Quarter 2002 Results
Thermo LabSystems Delivers SampleManager 2002
LIMS
Neolytica to Deliver Nautilus LIMS Via ASP Architecture
Labtronics to Provide Compliant Integration
of Agilent Technologies Network Data Systems with LIMS
Rosetta Biosoftware and Agilent Technologies
Announce First Gene Expression Data Analysis System to Support Compliance
with 21 CFR Part 11
Agilent Technologies to Provide Probe Sequence
Information Derived from Incyte Genomics to Microarray Customers
Agilent Technologies Announces Free E-Seminars
Explaining the Recovery, Purity and Mass-Based Fraction Collection Aspects
of Preparative HPLC
Agilent Technologies Easy View LC/MS Data Browser
Software Simplifies Data Review for Drug Discovery
Scientific Software Announces New RS232 Interfacing
Solutions for CyberLAB Knowledge Engineering System
Patheon Chooses NuGenesis Scientific Data Management
Solution
Zymark Workstations Installed at TNO Collaboration
to Launch Biological Material Discovery Service
Laboratory Informatics 2003 to be Held at
Pittcon
A new venue, Laboratory Informatics 2003, will be held in conjunction with
the annual Pittsburgh Conference, Pittcon. Attracting over 23,000 registrants
last year, Pittcon is one of the world's largest annual expositions for
analytical instrument and laboratory equipment. The Laboratory Informatics
2003 exposition is a first at Pittcon and results from a partnership agreement
between the Pittcon organizing committee and LIMS Institute, Inc. Laboratory
Informatics 2003 will include four symposia, contributed paper sessions,
and the special area within the main exhibition hall where laboratory informatics
exhibitors will be grouped together. More information on Laboratory Informatics
2003 is available at http://www.limsconference.org.
New AIS Prescheduling Module Manages Stability
Trials And Result Quality In the Pharmaceutical and Food Industries
Analytical Information Systems (AIS) has released a new version of their
Stability Pre-Scheduling module that is particularly appropriate for the
pharmaceutical and food industries since the stability of medicines and
packaging is of key importance to the pharmaceutical industry while shelf
life studies and packaging stability is important to the food industry.
Unstable medicines and food with very short shelf life can be very costly
to the manufacturer. The new Stability Pre-Scheduling module allows samples
to be pre-registered onto the LIMS for planned release at predetermined
times. AIS LIMS organises the work protocol by informing lab staff of what
resources are required for the stability study, what needs to be done and
when to do it. The new software will allow authorised users to modify screens
and data structures, as well as allow registered samples to integrate with
the AIS AQC system to allow active triggering of analytical quality control
standards. The software provides a variety of predefined text and graphic
reports of associated work and effort required for study planning which
can be modified by an authorised user using the proprietary AIS LIMS report
writer. The software provides for the management of stability studies in
a clear and concise manner suitable for many industries requiring pre-scheduling
of samples and associated work. For details, visit http://www.ais-lims.com.
Chinese Content Pages Now Available on StarLIMS.com
The StarLIMS.com website now facilitates the Chinese language. This was
made possible with the company's expansion into the Asia-Pacific region.
L.I.M.S. (USA) Inc. has established its' Asia Pacific center in Hong-Kong,
and has initiated sales and support channels throughout China, Hong Kong,
Taiwan, Malaysia and Thailand. L.I.M.S.' growing worldwide customer base
necessitates meeting different language requirements. The company will continue
these enhancements, providing web and brochure access to customers in Spanish,
French and now Chinese. For details, visit http://www.starlims.com.
Agaram to Introduce StarLIMS to the Indian
Market
Agaram Instruments (Chennai, India) and L.I.M.S. (Hollywood. FL) have announced
the commencement of joint operations in India. With over 20 years of experience
and leadership in the Indian analytical instrumentation and laboratory automation
markets, Agaram Instruments, will set up a new sales and support channel
for StarLIMS throughout the Indian sub continent. For details, visit http://www.starlims.com/agaram.htm.
Food Safety Net Services, Ltd. Selects LabVantage
for Next Generation Enterprise Quality Management LIMS
LabVantage Solutions, Inc., a leading provider of Life Sciences LIMS and
Enterprise LIMS solutions, has announced that Food Safety Net Services,
Ltd. has signed a software and services agreement for LabVantage Sapphire
for their San Antonio and Dallas/Fort Worth, Texas facilities. Food Safety
Net Services provides "one-stop shopping" for integrated services
and industry expertise that focuses on improving the effectiveness of food
safety and quality programs. Food Safety Net Services will be using Sapphire
to improve the management of scientific data and will streamline the documentation
process in Food Safety Net Services' ISO/A2LA accredited laboratories, which
is critical to the A2LA accreditation. The systems will also allow Food
Safety Net Services to gain process efficiencies through automation, and
to provide clients with access to testing information via secure Internet
browser connections and Sapphire "virtual user" licenses. Food
Safety Net Services has distinguished itself with its vision of food safety
from "farm to fork" by combining microbiological and chemical
laboratory service with consulting and auditing services, educational and
crisis management programs, and regulatory support. Their goal is to help
clients build and implement the most effective food safety and quality programs
possible. Food Safety Net Services will implement LabVantage Sapphire using
a centralized Microsoft SQL Server database, an application server for business
rules automation, and Business Objects for reporting and ad hoc analysis.
Food Safety Net Services' customers will be able to submit and review samples
via a secure Internet browser connection. This approach provides a research
environment that is flexible and easy-to-maintain, and is scalable to meet
the changing needs of the organization as well as the needs of their client
base. For details, visit http://www.labvantage.com
or http://www.food-safetynet.com.
CREON.LAB.CONTROL Expands Presence In Eastern
Europe
CREON.LAB.CONTROL, the pioneer in intelligent analytical data management
technology, announced today that Ferenc Kiss had been appointed Area Sales
Manager Eastern Europe. In his role, Ferenc oversees the sales activities
for all Eastern Europe countries. He is responsible to further penetrate
the life science industry comprised of the Research & Development, Quality
Assurance and Production segments. "The Eastern Europe economy is strengthening
and has tremendous potential," says Dr. Daniela Weber, CREON.LAB.CONTROL's
International Sales Manager. "With the European Union associating countries
in Central Eastern Europe, CREON.LAB.CONTROL is intensifying its activities
in this region. We will be able to meet the special needs of our customers
in these countries." Ferenc earned his international bachelor degree
as industrial engineer from the University of Brasov, Romania. Ferenc is
speaking fluently Romanian, Hungarian, English and German. For details,
visit http://www.creonlabcontrol.com.
InnaPhase Corporation Announces New Chief Executive
Officer and New Product Offering Scheduled for Release in 2003
InnaPhase Corporation Chairman of the Board, Peter Ryan, has announced the
appointment of Jo Webber, Ph.D., as he new Chief Executive Officer. Dr.
Webber previously held the position of Executive Vice President of Sales
and Operations for the organization. In her new role, Dr. Webber will oversee
all of the company operations and will continue to lead the company-wide
effort to develop and market innovative technology solutions for the life
sciences industry. Dr. Webber will also join the InnaPhase Board of Directors.
"This appointment is evidence of our commitment to continue to provide
our customers, organization and investors with the highest quality of excellence
in leadership," said Peter Ryan. "With over 15 years of operational
and senior management experience combined with her industry leading vision,
I am confident that Jo will lead us in our goal to assist companies in accelerating
products to market faster while taking InnaPhase to a new level of growth
in order to achieve our corporate objectives." "This is a very
exciting time at InnaPhase Corporation as we prepare for the expansion of
our world leading LIMS solutions developed specifically to meet the needs
of the entire pharmaceutical industry," said Dr. Webber. "Pharma
LIMS is our new suite of LIMS solutions designed to operate in a 21 CFR
Part 11 compliant environment. The Pharma LIMS suite includes: Galileo LIMS
for permeability, metabolism and enzyme inhibition, Watson LIMS for pre-clinical
and clinical bioanalysis, and Newton LIMS for batch release, quality control,
formulation, stability and analytical development." InnaPhase Corporation
is a leading supplier of regulatory compliant technology solutions for the
pharmaceutical and biotechnology industries. For details, visit http://www.innaphase.com.
Thermo Electron Names Marijn E. Dekkers CEO;
Richard F. Syron to Serve as Full-Time Executive Chairman
Richard F. Syron, chairman and chief executive officer of Thermo Electron
Corporation has announced that Thermo's board of directors has unanimously
concluded that retaining a full-time executive chairman and separating his
responsibilities from those of the CEO is in the best interests of the company.
Accordingly, the board has elected, effective immediately, Marijn E. Dekkers,
currently president and chief operating officer, to the position of president
and chief executive officer. At the same time, Mr. Syron will assume a newly
created position of full-time executive chairman with specific assigned
duties. The COO position will not be filled. Under the new structure, as
executive chairman, Mr. Syron, among other duties, will participate fully
in the strategic planning process and additionally will be responsible for
the review and approval of the company's financing and acquisition strategies,
the supervision of the internal audit and investor relations functions,
and the supervision of all disclosure policies and practices and related
filings, as well as compliance with New York Stock Exchange and U.S. Securities
and Exchange Commission rules, and the company's Business Conduct Policy.
As president and CEO, Mr. Dekkers will have responsibility for all aspects
of the company's business and operations, including formulating, implementing,
and monitoring the company's strategic plan together with the executive
chairman and the full board. All executive officers of the company (except
the executive chairman) will report to Mr. Dekkers. Marijn Dekkers, 45,
joined Thermo in 2000 after serving as president of the electronic materials
division of Honeywell International (formerly AlliedSignal), a company he
joined in 1995. From 1985 to 1995, he worked for General Electric, where
he started his career as a research scientist at GE's corporate R&D
center. A native of the Netherlands, Mr. Dekkers holds a bachelor's degree
in chemistry from the University of Nijmegen and master's and doctorate
degrees in chemical engineering from the University of Eindhoven. Richard
Syron, 59, joined Thermo as a member of the board of directors in September
1997, and was appointed president and CEO in June 1999, and chairman of
the board in December 1999. Previously, he was chairman and chief executive
officer of the American Stock Exchange from 1994 until 1999, president and
chief executive officer of the Federal Reserve Bank of Boston from 1989
to 1994, and president of the Federal Home Loan Bank of Boston from 1986
to 1989. Mr. Syron holds a bachelor's degree in economics from Boston College,
and master's and doctorate degrees in economics from TuftsUniversity. For
details, visit http://www.thermo.com.
Latest Informatics Advances to be Showcased
by Thermo LabSystems at Pittcon 2003
Thermo LabSystems has announced that it will be exhibiting new developments
with its suite of solutions at two separate booths at Pittcon, March 10-13,
2003. In addition to space on the Thermo Electron booth #3769, Thermo LabSystems
will also be exhibiting at the adjoining Laboratory Informatics 2003 exposition
on booth #4359. Pittcon 2003 is being held at the Orange County Convention
Center, Orlando, Florida. Along with its sister business Thermo Galactic,
the company will be exhibiting for the first time as Thermo Electron Informatics.
On its two booths, 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 suite. Through interfacing these systems to optimize automation
in the laboratory, Thermo claims to offer the most comprehensive, integrated,
single-vendor laboratory informatics solution available. Thermo will also
highlight a new public domain XML (eXtensible Markup Language) schema known
as GAML (Generalized Analytical Mark Language), which its eRecordManager
solution utilizes when archiving analytical instrument data in XML. Atlas
CDS will also be demonstrated working with Thermo Finnigan GC and LC instruments.
For details, visit http://www.thermolabsystems.com.
Thermo Presents Latest Informatics Solutions
at Bio-ITWorld 2003
Thermo LabSystems has announced that it will be exhibiting at the BioITWorld
2003 event, on booth #1414 at the Hynes Convention Center, Boston, USA.
Bio-ITWorld Conference & Expo takes place from March 25-27 2003. Thermo
will be exhibiting its solutions, along with those of its sister business
Thermo Galactic, as Thermo Electron Informatics. Booth presentations will
focus on Nautilus LIMS and the eRecordManager solution for data archival
and knowledge management. In addition to supporting compliance with 21 CFR
Part 11, Thermo claims its suite of systems is unrivalled in terms of equipping
researchers and bioinformaticians with the knowledge to generate leads,
terminate flawed projects early, and make more-informed decisions. The company
will be highlighting a new public domain data model called GAML (Generalized
Analytical Mark Language) based on XML (eXtensible Markup Language), which
its eRecordManager solution utilizes when archiving analytical instrument
data. As a result of a collaborative product integration project, Thermo
will also be proposing a new enterprise-wide hierarchical storage solution
for analytical data. The new solution is being developed to meet the challenge
of making electronic records highly accessible and searchable, while minimizing
the cost of long term archival through a wide variety of offline storage
media. The project is part of a new strategic alliance and product development
initiative, to be announced early in 2003. For details, visit http://www.thermolabsystems.com.
Scimcon and LabVantage Solutions Form Strategic
Business Agreement
LabVantage Solutions, Inc., a leading provider of Life Sciences LIMS and
Enterprise LIMS solutions, and scientific information management consultancy
Scimcon, have announced a marketing agreement that will enable both parties
to leverage their complementary software offerings and consultant services.
"The new relationship will benefit customers by allowing LabVantage
to offer Scimcon's business and IS consultancy services, and enabling Scimcon
to leverage LabVantage's position in Life Science LIMS and Enterprise LIMS
in the United States and Europe", said Trevor de Silva, Scimcon's Director
and General Manager. "The alliance also further strengthens Scimcon's
relationship with the LIMS marketplace and will provide us with up to the
minute product information about LabVantage's offerings, which in turn means
we can provide an even more informed service to clients." LabVantage
and Scimcon kicked off their new relationship by offering a free web seminar
in December 2003. The presentation, entitled Industrializing the Drug Development
Process, includes a discussion from Scimcon's Trevor De Silva, "Managing
the Information Explosion in Bioinformatics." A demonstration of LabVantage
Sapphire Informatics for companies looking to industrialize their drug development
process will follow. For details, visit http://www.labvantage.com.
Paperless Laboratories Will Encourage Collaboration
According to a Poll by NuGenesis Technologies
According to a recent poll conducted by NuGenesis Technologies Corporation,
a market leader in Scientific Data Management, 58 percent of those surveyed
believe that the ability to share data is the most significant benefit of
a paperless environment. Increased collaboration and the ability to share
data, greatly speeds up the drug discovery process because it allows the
entire organization to view others experiments and data. However, despite
a greater move towards a paperless environment, most scientific laboratories
are still paper-based with experiments being archived in notebooks. Seventy
eight percent of the participants cited cost and resources as major obstacles
to implementing a paperless laboratory, however 63 percent of the respondents
were confident that their organization would become paperless in the next
five to seven years. Most laboratories are using a mix of software systems
because they are unaware of any comprehensive software systems that are
compliant with 21 CFR Part 11 and have electronic signature capabilities.
Fifty one percent of the participants' systems were missing some Part 11
technical control functionality and 23 percent were using systems that did
not provide them with electronic signature functionality. 21 CFR Part 11,
which had paved the way to complete electronic submissions to the FDA in
the future, has served as an impetus to managing regulated data in e-format
rather than keeping paper-based printouts of the data on file, as has been
the long-term practice in the pharmaceutical, biotech and other science-based
industries. NuGenesis develops and markets the web-enabled NuGenesis Scientific
Data Management System (SDMS) which allows quick and easy searching, retrieval
and viewing of information, regardless of physical location or proprietary
format while providing a platform for comprehensive communication and collaboration
of scientific data. For details, visit http://www.nugenesis.com.
NuGenesis Announces New Interface for NuGenesis
SDMS and Labcon NuConnect
Labcon Engineering BV and NuGenesis Technologies have introduced a new
integration strategy for interfacing laboratory instruments to LIMS based
on Labcon's NuConnect and the NuGenesis Scientific Data Management System
(SDMS). Labcon's NuConnect is a Toolkit application that addresses the key
requirements for interfacing to a LIMS so that the actual interfacing process
is completely transparent to the user. Features include: Feedback, Tracking
results, Data integrity, No user intervention in the actual interfacing
process, and No intermediate results. NuGenesis Technologies provides two
versatile and powerful tools for use with the NuGenesis SDMS: Template Builder
and providing a programmable interface to the NuGenesis SDMS. Labcon's NuConnect
together with NuGenesis' SDMS, Template Builder, and Software Development
Kit (SDK), provide a fully integrated solution for interfacing any laboratory
equipment with any LIMS. For details, visit http://www.labcon.nl
or http://www.nugenesis.com.
Zymark Introduces Easy-to-Use Software for
Linking Laboratory Instruments
Zymark Corporation has introduced iLink, a new "point and shoot"
software interface that simplifies use of Zymark's Twister II robot. With
this new software, any instrument that uses microplates can have automated
stacking capability added to it by connecting the Twister II. The iLink
software extends the power of automation to individual instruments, such
as readers and washers, with the flexibitity to pass plates through several
instruments building to a powerful, integrated system. For details, visit
http://www.zymark.com.
McClellan Pledges Shorter Drug Reviews
FDA Commissioner Mark McClellan said the agency will devote more resources
to shortening drug review times, as well as improving adverse event tracking.
The FDA plans to hire about 450 additional workers, most of whom will augment
the regulatory and scientific staff that reviews drug applications, McClellan
told attendees this week at an American Enterprise Institute for Public
Policy Research healthcare conference. The agency needs to ensure that anti-terror
treatments and vaccines are made available to the public as quickly as possible,
he added. New staff will also beef up post-marketing studies to track adverse
events for products on the market. Improved adverse-event tracking could
help the FDA make faster recommendations for product label changes and initiate
better education programs for healthcare providers and patients, McClellan
said. For details, visit http://www.fda.gov.
GAO Criticizes Lengthy FDA Drug Ad Reviews
The FDA is taking too long to review the accuracy of prescription drug advertising
claims, causing some enforcement letters to be issued after an ad campaign
has run its course, the General Accounting Office (GAO) said November 4.
The FDA Division of Drug Marketing, Advertising and Communications review
of drug advertisements has been "adversely affected" by a nearly
year-old procedure that requires untitled and warning letters to be reviewed
by the FDA's Office of Chief Counsel (OCC), GAO said. In response to the
GAO report, OCC has set a goal of reviewing draft regulatory letters within
15 working days after receiving them. Sens. Susan Collins (R-Maine), Barbara
Mikulski (D-Md.) and James Jeffords (I-Vt.), and Reps. Nick Rahall (D-W.Va.)
and Joseph Hoeffel (D-Pa.) requested GAO's report. To see the report, go
to http://www.gao.gov and click on GAO
Reports, then Today's Reports, then December 4, 2002.
Device and Diagnostics Manufacturers Will Need
Different Quality Systems for U.S. and International Markets
The FDA's Devices Center has said that it does not intend to update its
Quality System Regulation (QSR) to match coming changes in international
quality standards. If the QSR is not harmonized with international standards,
manufacturers will have to implement different standards for products sold
in the U.S. and those marketed in the rest of the world. The International
Organization for Standardization (ISO) is updating its medical device quality
standard, which takes effect in November 2003 as ISO 13485-2003. The European
Union (EU) will also revise its medical device directive within the next
two to three years. In the interim, EU authorities will recognize ISO 13485-2003.
There are enough differences between the QSR and ISO 13485-2003 that manufacturers
will need to establish quality systems that meet both sets of requirements.These
developments mean new regulatory obstacles could hinder an organization's
ability to drive products to market and keep them there. A monthly newsletter,
The GMP Letter, delivers in-depth analysis of trends in regulatory development
and enforcement for medical device and diagnostics manufacturers. Each issue
of The GMP Letter also reviews actual warning letters, recalls, EIRs and
483s. The newsetter also offers authoritative insights into critical issues
affecting the medical device and diagnostics marketplace, including the
effects of the device user fee act, Mutual Recognition Agreement (MRA) progress,
reimbursement for durable medical equipment and more. The cost to subscribe
is $527. For details, call +1 (703) 538-7600 or visit http://www.fdanews.com.
FDA Releases Books to Facilitate Surviving
GMP Inspections
According to FDA officials, GMP inspections of drug manufacturing facilities
will increase about 50 percent in fiscal year 2003. Surviving an FDA Inspection,
Volumes I and II provide information to act upon before inspectors arrive.
The books include all the official guidances on the FDA's new QSIT approach,
which examines the physical aspects and manufacturing processes of six systems.
They also contain useful tips for ensuring that those systems, as well as
an organization's documentation and employees, are ready for the FDA inspector's
visit. These books provide the official source documents plus expert advice
to make inspections run smoothly. The books sell for $264 each; a volume
discount of 20% applies if both volumes are purchased at the same time.
Shipping and tax will be added. For details, visit http://www.fdane
ws.com/wbi/bookstore/107-1.html.
FDA Releases Books on How to Design and Conduct
of Clinical Trials
The FDA plans in 2003 to step up its investigations of clinical practices,
including data integrity and reliability as well as human subject protection.
The agency now will inspect clinical trial sites as early as the IND or
IDE stages of drug and device approval. The brand new publication Navigating
Good Clinical Practices: FDA's Guidelines for Clinical Trials provides the
critical FDA guidances necessary to ensurecompliance with clinical trial
regulations. The book addresses the entire range of clinical practices,
including: Interaction with institutional review boards and data monitoring
committees; International harmonization issues; Treatment of gender, ethnic
and age data; The effect of Part 11 guidelines; How to handle clinical holds
and combination products; and, Differing rules regarding conflicts of interest.
The book costs $218. Shipping and handling is additional. For details, visit
http://www.fdane
ws.com/wbi/bookstore/160-1.html.
FDA Book Helps Prepare for Requirements of
Adverse Event Reporting
Information on what to do when an adverse event occurs is contained in Understanding
FDA Drug and Biologic Adverse Event Regulations: An Executive Guide, 2003
Edition, a comprehensive collection of official documents plus advice for
navigating the reporting process. Every drug and biologics manufacturer
must know how to report an adverse event, and the process can be complex.
For instance, organizations must provide four categories of information
within a 15-day window while observing HIPAA privacy policies. The book
assembles the key facts in one handy reference book, including: What makes
an event reportable; What information is required for making a report; What
additional information may be relevant; and Key milestones in the reporting
schedule. Highlighted in this new edition are issues in implementing electronic
reporting, including Part 11 requirements and evolving international MedDRA
standards. This resource also includes the official rules and guidances
that describe the FDA's requirements, as well as other key documents from
the FDA and the International Conference on Harmonization. The cost for
the book is $215 plus shipping and handling. For details, visit http://www.fdanews.com/wbi/bookstore/26-1.html.
FDA Plans Tougher Dietary Supplement Oversight
FDA Commissioner Mark McClellan unveiled a consumer health initiative December18
that will require dietary supplement firms to make "science-based"
claims about the health benefits of their products. The agency will create
a new advisory committee on supplements, although it hasn't decided whether
the panel will perform the same functions as drug advisory committees, he
said. For details, visit http://www.fdanews.com.
Thermo LabSystems Introduces Enhanced LIMS
Functionality for Analytical Quality Control in Nautilus 2002 R3
Thermo LabSystems has announced that new Analytical Quality Control (AQC)
functionality is now available as part of the latest version of its Nautilus
LIMS. Nautilus 2002 R3 began shipping to customers on request during November.
AQC is a technique of monitoring the accuracy of analytical methohttp://www.fdanews.com/wbi/bookstore/26-1.htmlds
through the use of control samples processed by laboratory instruments.
Such information provides analysts with confidence that results acquired
from actual samples are correct. The new AQC functionality in Nautilus is
anticipated to generate particular interest from laboratories where samples
are taken from many diverse sources - for example, an environmental lab
testing samples from various points along a river using a wide variety of
instruments and analytical methods. LIMS functionality to support AQC is
also required in industries such as water, and food and beverage processing.
Using the new function, customers of Nautilus are now able to easily create
statistical charts to assist in monitoring control data, including charts
that plot individual results, mean and range values, and percentage difference
between two results that are acquired from duplicate entries on the LIMS
worksheet. All charts are generated in Nautilus according to the industry-standard
Shewhart rules on statistical control techniques. Nautilus is Thermo LabSystems'
latest LIMS product, focused on improving laboratory productivity and reducing
the total cost of ownership. For details, visit http://www.thermolabsystems.com.
LabVantage Sapphire Selected by WestFarm Foods
to Help Reduce Operating Costs and Improve Customer Service
LabVantage Solutions, Inc., a leading provider of Life Sciences LIMS and
Enterprise LIMS solutions, has announced that WestFarm Foods has signed
an enterprise software and services agreement for LabVantage Sapphire. WestFarm
Foods produces a full line of dairy-based and other products for consumer,
commodity and specialty markets. With plants located in Washington, Oregon,
Idaho and California, the company serves western, national, and international
markets. WestFarm Foods will be using Sapphire to improve their overall
management of quality and production processes and to provide customers
with access to quality data via Sapphire's browser-based, "virtual
user" licenses. WestFarm Foods will implement LabVantage Sapphire with
a centralized Microsoft SQL Server database at their headquarters in Seattle,
Washington and will be integrating Sapphire with their Oracle CPG Information
Management System. Customers will be given virtual user licenses that will
enable them to submit and review quality samples via secure Internet browser
connections that expand data access beyond the laboratory's traditional
four walls. This approach enables WestFarm Foods to improve customer communication
and service. In addition, this form of software deployment is easy-to-maintain
and scalable to keep pace with the changing needs of the organization. For
details, visit http://www.labvantage.com
or http://www.westfarm.com.
Agilent Technologies Ships Revision of Cerity
Networked Data Systems for Pharmaceutical QA/QC
Agilent Technologies Inc. has announced shipments of a revision of Agilent
Cerity Networked Data System (NDS) for Pharmaceutical QA/QC. This revision
allows analytical laboratories to deploy Cerity NDS for Pharmaceutical QA/QC
in terminal server environments. Terminal server configurations have become
very popular in laboratories that are subject to FDA regulations because
this technology enables the use of software applications on so-called "thin
clients," which require significantly less effort in terms of software
installation, distribution, validation and qualification. This capability
is particularly relevant for large, multi-user, multi-technique laboratories,
helping them to cut costs and increase productivity. Further, this revision
of Cerity NDS for Pharmaceutical QA/QC adds instrument control and data
acquisition capabilities for Agilent 6850 gas chromatographs, widely used
in QA/QC laboratories in the pharmaceutical and other industries. This complements
the level-4 instrument control of networked instrumentation from Agilent,
including Agilent 1100 Series liquid chromatographs, Agilent 6890 and 6850
gas chromatographs, and Agilent 35900E dual channel interfaces. Cerity NDS
for Pharmaceutical QA/QC also provides full instrument control of GPIB-based
instrumentation such as Waters Alliance systems. For details, visit http://www.agilent.com/chem/nds.
Agilent Technologies' President and CEO to
Assume Board Chairmanship
Agilent Technologies Inc. has announced that Ned Barnholt, Agilent president
and CEO, has been named chairman of the company's Board of Directors. Barnholt
replaces Gerald Grinstein, who will retire from the board in March 2003.
Grinstein, 70, will remain as lead director through February. Upon Grinstein's
retirement, board member David Lawrence will assume the position as lead
director. Grinstein became a director and non-executive chairman of Agilent's
board when the company was launched in 1999. As the former chairman and
CEO of both Burlington Northern and Western Airlines, Grinstein brought
a wealth of experience in board management issues to Agilent, which had
just been spun off from Hewlett-Packard. Barnholt, 59, was named president
and CEO at the time of Agilent's spin-off from Hewlett-Packard in 1999.
Prior to that, he served as executive vice president and general manager
of HP's Measurement Organization. Barnholt began his career with HP in 1966.
For details, visit http://www.agilent.com.
Agilent Technologies Reports Fourth Quarter
Results at Breakeven
Agilent Technologies Inc. has reported orders of $1.50 billion and net revenue
of $1.74 billion for the quarter ended Oct. 31, 2002. On an operating earnings-before-goodwill
(EBG) basis, the company lost $2 million, or $0.00 per share. This compares
with prior company expectations of an EBG loss of $0.10 to breakeven per
share on revenues of $1.60 to $1.70 billion. After $92 million of non-cash
goodwill and amortization charges and $256 million of restructuring expenses,
the net fourth quarter GAAP loss was $236 million, or $0.51 per share. "Our
fourth quarter breakeven performance demonstrates that our drive to restore
Agilent to financial health is succeeding," said Ned Barnholt, Agilent
president and chief executive officer. "I'm gratified by these results,
which are at the top end of our expectations. These results demonstrate
that the disruptions in the third quarter from the implementation of our
new company-wide ERP system are behind us." Barnholt noted that fourth
quarter performance improvements were widespread. "Our Life Sciences
and Chemical Analysis and our Semiconductor Products groups were solidly
profitable, as was our Automated Test Group. The operating loss in the rest
of our test and measurement businesses was reduced by more than $130 million
compared to last year or the prior quarter." Order cancellations were
stable again in the fourth quarter at about $90 million and were well below
last year's $250 million. Balance sheet improvements also continued in the
fourth quarter, with inventories lower by about 25 and 30 days, compared
to last year and the prior quarter, respectively. Capital spending in the
quarter was about $90 million, bringing full year spending to only $300
million, compared to $880 million in 2001. In segment results, Life Sciences
and Chemical Analysis turned in an excellent performance in the fourth quarter.
Orders were up sequentially and year-over-year in both the Life Sciences
and Chemical Analysis businesses. Overall, seasonally strong orders were
up 8 percent compared to last year and 14 percent sequentially. Revenues
of $298 million were 4 percent ahead of last year and the prior quarter.
Operating profits of $45 million represent about a 30 percent Return on
Invested Capital (ROIC) for the segment compared to ROIC of 28 percent in
the prior quarter and 24 percent one year ago. Looking ahead, the company
expects business to remain difficult. First quarter revenue is expected
to be in the range of $1.5 billion to $1.6 billion. Including the $0.07
impact of Agilent's ERP and CRM systems implementations, the company expects
operating EBG in the range of a $0.05 to $0.15 loss. "The outlook for
fiscal 2003 is highly dependent on the pace of recovery in our markets,"
Barnholt said. "The most recent industry forecasts, along with our
continued new product successes, would suggest a revenue increase of 5 to
10 percent, consistent with the range of most analyst projections. While
we're comfortable with the consensus earnings projections for 2003, there
may be some slight upside based on Agilent's success in reducing structural
costs and in beginning to realize the benefits of our IT systems investments.
For details, visit http://www.agilent.com.
Scientific Software Launches New Customer
Support Forum
Scientific Software, Inc., a leader in providing software solutions to the
scientific community, has launched a new Customer Support Forum accessible
through their website. The new forum provides customers with a dynamic interface
for product questions, online discussion groups and up-to-date product releases.
Scientific Software customers with valid service contracts will find information
about their CyberLAB Knowledge Engineering System or EZChrom Elite Chromatography
Data System. Visitors to the SSI Support Forum can participate in online
discussion groups, download new product enhancements, and learn new techniques
for utilizing specific product features. For details, visit http://www.scisw.com.
Scientific Software Introduces Novel Device
for Instrument Control and Data Acquisition
Scientific Software, Inc. has introduced the OpenLAB iCON XP for intelligent
control and data acquisition of analytical instrumentation. iCON XP creates
a complete networking solution by reducing the number of dedicated computers
and enabling full instrument Ethernet connectivity. The first implementation
of OpenLAB iCON XP will be with Scientific Software's EZChrom Elite client/server
chromatography data system. Used in combination with EZChrom Elite, iCON
XP collhttp://www.westfarm.com/ects
data from multiple chromatographs, enables networked instrument control
and buffers data to ensure data integrity in the event of a network failure.
Control of over 200 instrument modules is immediately available. The system
can be configured to collect data from serial, USB, IEEE, SCSI or analog
devices via the SS420X A/D converter. For details, visit http://www.scisw.com.
FDA to Open Combination Products Office by
December 25
The FDA's new Office of Combination Products, responsible for overseeing
the approval and regulation of drug-device and other combination products,
will begin operating by December 25. The new office will centralize authority
over combination products and ensure their prompt assignment to the appropriate
regulatory center for pre- and post-market review, FDA Senior Associate
Commissioner Murray Lumpkin said at a November 25 public workshop on the
FDA's regulatory strategy for combination products. The office also will
resolve disputes over products and prepare a report to Congress on the office's
impact on combination product regulation, Lumpkin said. The Medical Device
User Fee Act of 2002 directed the agency to create the new office. Currently,
the FDA assigns combination products to the Drug, Biologics, Foods or Devices
Center based on their mode of action, under a series of Intercenter Agreements.
For details, visit http://www.fda.gov.
McClellan Says Reviews Must Keep Up with Scientific
Advances
In his first remarks as head of the FDA, Commissioner Mark McClellan said
the agency needs to consider changing its regulatory review process to keep
up with advances in medical technology. "We can expect more breakthroughs
resulting from a better understanding of the human genome and of the way
proteins and other chemicals work," McClellan said November 15 at the
groundbreaking of a new FDA facility in White Oak, Md. "These new kinds
of medical technologies may require some new thinking at FDA, in terms of
how we should best design our review processes for drugs, devices and biological
treatments to help Americans get safe and effective treatments as quickly
as possible and at the lowest possible costs." McClellan also said
the FDA needs to do a better job identifying adverse events and improving
drug safety. "[Another] challenge ahead for FDA is to help medical
professionals and patients reduce preventable adverse events," he said.
McClellan was sworn in November 14. For details, visit http://www.fda.gov.
Part 11 Draft Guidance Adds New Scope to FDA
Scrutiny of E-records
The FDA has released a new Part 11 draft guidance on electronic copies that
outlines seven key principles and practices that the agency advises industry
to follow p; and its inspectors to scrutinize:
- Electronic copies of e-records provided to the FDA should be accurate
and complete, but they do not necessarily have to be in the same file format
and in the same media as the original e-records.
- The process of making an electronic copy of an e-record in a file format
that differs from the original should be validated.
- Copies of hyperlinked records incorporated by reference should be included
with the electronic copy of the electronic record.
- Electronic copies of database queries should be included with electronic
copies of electronic records when appropriate.
- Electronic copies of electronic records should include, or be appended
with, an authentication value.
- Electronic copies of electronic records should be in a file format and
on media that enable the FDA to read and process record data.
- If the original electronic records were signed electronically, electronic
copies of the original electronic records should have electronic signatures
that are capable of being authenticated.
Experts alerted Part 11 Compliance Report editors to potential difficulties
in compliance stemming from changes in the size of an electronic record
unrelated to alterations, the use of proprietary software tools and the
inability to electronically "sign" information in some common
software programs. These are only a few of the issues that FDA inspections
will expose. Available electronically and in print, Part 11 Compliance Report
(24 issues per year) costs $699. (For print delivery outside North America,
add $25.) For details, visit http://www.fdanews.com.
Recommendations in Part 11 Guide Raise Industry
Concerns
Submitting electronic records to the FDA could become more time-consuming
and complicated if a new draft agency guidance stands as written, experts
said. Ofni Systems President Ty Mew said he found the guidance to be vague
in some areas, especially in its definitions of what constitutes a single
record and whether some parts should only be applied to new systems and
not legacy systems p; those systems installed before the Part 11 rule
was published. The document lays out seven key principles and practices
that the agency advises industry to follow p; and its inspectors to
scrutinize. They include ensuring that the process of making electronic
copies of e-records is validated and that electronic copies of records are
in a file format and on media that enable the FDA to read and process data.
Comments on the draft guidance, which will appear in the Nov. 12 Federal
Register, are due Feb. 12. To view the document, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/00d-1540-gdl0001.pdf.
PerkinElmer's New LABWORKS ES LIMS Streamlines
Key Business Processes
PerkinElmer Life and Analytical Sciences has released its new LABWORKS
Enhanced Security (ES) LIMS software. The LABWORKS ES version increases
the efficiency of business processes for the environmental, chemical, petrochemical,
water and wastewater, and food and beverage industries. Building on the
existing strengths of LABWORKS, such as its state-of-the-art discovery implementation
process and low cost of ownership, the new LIMS offers a centralized point
of authentication that dramatically simplifies the process of securing critical
laboratory data. Integration with other systems and new reporting tools
improve user productivity. The LABWORKS ES version also provides other significant
enhancements, including expanded data fields and barcode printing capabilities.
Seamless data migration increases efficiency, while a new login server streamlines
the sample login process. An enhanced document management capability links
to established Standard Operating Procedures (SOPs) and Material Safety
Data Sheets (MSDS) documents. The LABWORKS ES LIMS also offers users greater
ease-of-use through hand-held computer integration and a simplified custody
tracking feature. For details, visit http://www.perkinelmer.com.
PerkinElmer Launches New Microarray Informatics
Platform
PerkinElmer, Inc., a leading provider of drug discovery, life science research
and genetic disease screening solutions, has announced the introduction
of a new generation microarray informatics solution to automate integrated
data management from microarray spotters, scanners and gene expression data
analysis. With current microarray data tracking and data analysis requirements
going beyond first generation file storage formats and excel spreadsheet
analysis macros, this set of laboratory microarray tools provides gene expression
researchers with powerful ArrayInformatics software. This software automates
data flow from SpotArray 24 or SpotArray 72 microarray printers and the
ScanArray Express family of microarray scanners. This integrated microarray
laboratory software significantly streamlines the microarray production
and analysis process. Currently, data tracking and analysis is a predominately
manual process that can slow productivity with questionable data integrity.
PerkinElmer's microarray-focused LIMS enables more dynamic, comprehensive
process record keeping and accountability. For details, visit http://www.perkinelmer.com/microarray.
PerkinElmer Forms Life and Analytical Sciences
Organization
PerkinElmer, Inc. has announced the combination of its Life Sciences and
Analytical Instruments business units into a new integrated business named
Life and Analytical Sciences. The new business will leverage the strengths
of the respective sales, service, and R&D organizations along with operational
scale to better serve customers. Peter B. Coggins, PhD., formerly president
of PerkinElmer Life Sciences, will serve as president of the new organization,
effective immediately. The new organization has approximately $1 billion
in revenue, more than 2,000 sales, service and applications support personnel,
and an annual R&D budget of $65 million. "An integrated Life and
Analytical Sciences organization will enable PerkinElmer to provide a single,
unified face to our customers in the biopharmaceutical and clinical diagnostics
markets, as well as bring greater resources to our analytical customers,"
said Gregory L. Summe, chairman and CEO of PerkinElmer, Inc. "It also
enables us to better leverage our R&D investment, global sales and service
network, and operational capabilities. This simpler, more streamlined structure
is consistent with our strategy of developing a cost-effective, customer-oriented
and innovative organization, and is an important step in growing our health
sciences businesses. Peter Coggins brings 29 years of health sciences experience,
exceptional leadership skills, and a strong customer focus, making him the
ideal candidate to lead the new Life and Analytical Sciences team."
Stephen P. DeFalco, the current president of Analytical Instruments, will
assist in the transition through the end of the year. The new organization
will be headquartered in Boston, and the company will continue to maintain
a significant presence in Shelton, CT, formerly headquarters of the Analytical
Instruments business unit. For details, visit http://www.perkinelmer.com.
PerkinElmer Extends 21 CFR Part 11 Compliance
For FT-IR Analyses in the Pharmaceutical Industry
PerkinElmer Instruments has announced an extended version of the Spectrum
Enhanced Security (ES) software for Fourier Transform-Infrared (FT-IR) and
Fourier Transform-Near Infrared (FT-NIR) spectroscopy, providing technical
compliance with the FDA's 21 CFR Part 11 regulations for pharmaceutical
and related companies. The Spectrum ES V5.00 software increases efficiency
for both Quality Assurance/Quality Control and product development laboratories,
saving time and money. The Spectrum ES V5.00 software is now available for
the Spectrum GX and Spectrum GX FT-Raman systems, as well as the Spectrum
One and Spectrum One NTS QA/QC testing systems, extending compliance from
routine acceptance checks on incoming raw materials and finished products
through formulation development and troubleshooting applications. The Spectrum
ES V5.00 software assures the integrity of electronic records by providing
a suite of powerful security features, including password-protected access
control, multi-level user permissions, and comprehensive audit-trailing.
A security tool ensures that valuable legacy data can be used safely after
inspection and security stamping. For details, visit http://www.perkinelmer.com/instruments.
PerkinElmer Reports Third Quarter 2002 Results
PerkinElmer, Inc. has announced third quarter 2002 GAAP earnings per share
from continuing operations of $0.08 on revenue of $366 million. For the
same period last year, GAAP earnings per share from continuing operations
were $0.33 on revenue of $348 million. Cash earnings per share from continuing
operations (which exclude the amortization of intangibles) for the third
quarter of 2002 were $0.11, including a $0.04 per share net benefit from
the early retirement of debt and the reclassification of the Fluid Sciences
business unit into continuing operations. This compares to cash earnings
per share of $0.40 for the prior year period (which exclude the amortization
of intangibles, goodwill and non-recurring items). Net earnings per share
from total continued and discontinued operations for the third quarter of
2002 were $0.06 on a GAAP basis and $0.09 on a cash basis. Revenue from
continuing operations for the third quarter of 2002 was up 5% over the same
period last year. Third quarter organic revenue, which excludes the effects
of acquisitions and divestitures and the impact of foreign exchange, declined
5% from the same period last year. PerkinElmer reports organic revenue to
provide investors with a consistent basis for comparing the performance
of its operations over different periods. As a result of market conditions,
the company decided to retain its Fluid Sciences business unit, which provides
sealing solutions and advanced fluid containment technologies to the aerospace,
semiconductor and power generation markets. The company reclassified the
results of its Fluid Sciences business unit into continuing operations.
All financial data in this press release, including data for prior periods,
have been adjusted to give effect to the reclassification of the results
of the Fluid Sciences business unit into continuing operations. Of interest
to LIMS professionals are the financial overview by segment: Life Sciences
reported revenue of $118 million for the quarter, up 57% over the third
quarter of 2001, due to the inclusion of Packard BioScience. Organically,
revenue declined 7%. Double-digit growth in genetic screening, and growth
in reagents and service sales was offset by weakness in sales of instrumentation
to large pharmaceutical customers. GAAP operating margin for the quarter
of 4% and cash operating margin of 9% were down year-over-year reflecting
the impact of lower volume and investments in sales and marketing. Analytical
Instruments reported revenue of $115 million for the quarter, a decline
of 12% from the same period in 2001 on a reported basis and down 5% on an
organic basis. The decline was driven by weak instrument sales. GAAP operating
margin for the quarter of 4%, and cash operating margin of 5% were down
year-over-year due to lower volume and competitive pricing pressure. For
details, visit http://www.perkinelmer.com.
Thermo LabSystems Delivers SampleManager
2002 LIMS
Thermo LabSystems, a leader in laboratory informatics solutions and
services, has released the latest generation of its flagship enterprise
LIMS, SampleManager 2002. This version of SampleManager incorporates a host
of significant advances that are designed to enable scientists to make more
informed decisions based on improved capabilities for analyzing, searching,
reviewing, and reporting laboratory data. A highlight of the new functionality
is the release of the SampleManager 2002 Calculation Builder that provides
users with a powerful facility to simplify the creation of complex calculation
formulae. Such calculations are vital in allowing scientists to analyze
sample data effectively. The Calculation Builder features tools to create
calculations across different sample types and allows users to use previously
saved data-searching criteria in their calculations. An extensive library
of mathematical functions is also included. SampleManager 2002's newly enhanced
Selection Criteria function offers users a highly graphical and intuitive
interface from which to explore, query, and view subsets of sample data
filtered from multiple tables within the LIMS database. This dynamic facility
enables customers to select and display more meaningful groups of data from
which more informed decisions can be made. Further new developments include
a highly flexible SampleManager tabular reporting tool and user login authentication
using LDAP (Lightweight Data Access Protocol) and Windows NT functionality.
Another enhancement of SampleManager 2002 is new 'Most Recently Used' functionality
that provides users with single mouse-click access to most recently used
selections in a prompt field, most recently used items (e.g. a sample or
analysis) or most recently used commands (e.g. modify batches or view tests).
Such new features have been designed to offer significant timesavings for
end users in a solution that is already acknowledged as one of the most
user-friendly LIMS available. For details, visit http://www.thermolabsystems.com.
Neolytica to Deliver Nautilus LIMS Via ASP
Architecture
Neolytica, a single point of contact for outsourcing and contracting analytical
testing services, has formally signed an agreement with Thermo LabSystems
to offer the Nautilus LIMS solution to customers using the application service
provision (ASP) model. With this agreement, Neolytica will begin piloting
its LIMS service with a full operational launch anticipated in the first
half of 2003. Neolytica's LIMS offering will simplify the accessibility
and management of analytical data for its customers, allowing access to
world-class software without the need to secure costly licenses, purchase
hardware or employ expensive support resources. The Neolytica LIMS infrastructure
allows data access via the Internet, permitting customers to review their
data 24 hours-a-day from any location using an Internet browser. Well-defined
security architecture protects Neolytica's LIMS and data reporting infrastructure,
ensuring that only those with pre-defined privileges are allowed access.
Customers who receive Neolytica LIMS via ASP will experience fast, easy
and convenient service. A monthly rental fee replaces initial information
services capital expenditures, spreading cash flow over a manageable period
and eliminating upfront software and hardware costs. Hosting Nautilus LIMS
on a centrally managed server maintained by highly trained specialists also
provides users with the highest level of availability, scalability and performance.
For details, visit http://www.neolytica.com
or http://www.thermolabsystems.com
Labtronics to Provide Compliant Integration
of Agilent Technologies Network Data Systems with LIMS
Labtronics Inc. and Agilent Technologies Inc. will develop and market the
integration of Labtronics' LimsLinkCDS and Agilent ChemStation Plus Networked
Data Systems (NDS). LimsLinkCDS provides a secure, bi-directional interface
between Agilent ChemStation Plus NDS and any LIMS. Users of Agilent ChemStation
Plus NDS will now be able to integrate their chromatography data with their
enterprises' LIMS safely, securely and in accordance with the U.S. Food
and Drug Administration's ruling on electronic records and signatures (21
CFR Part 11). The alliance will benefit analytical laboratories in the life
sciences field by providing fully compliant solutions for acquisition and
management of data, and by integrating with LIMS to ensure regulatory compliance
and improve productivity in the drug discovery, development and manufacturing
process. LimsLink is specifically designed to provide for two-way communication
and data transfer between chromatography data systems (CDS) and LIMS. With
Agilent ChemStation Plus, this can be accomplished without creating files
outside of either application. Work lists can be uploaded from the LIMS
to the Agilent ChemStation base software and sample results can be retrieved
from the Agilent ChemStation Plus data organization module (Agilent ChemStore)
and delivered directly to the LIMS. By incorporating electronic signatures,
100 levels of password protection, and a full audit trail implementation,
LimsLink provides the level of security and accountability required for
compliance with FDA 21 CFR Part 11. The Agilent ChemStation Plus NDS family
provides modular software components for instrument control, data acquisition
and data management, giving the flexibility to choose a system that meets
both the lab's present and future requirements. The ChemStation base software
handles all applications including LC, LC/MS, GC, CE and CE/MS, and can
be extended with add-on software modules for data organization and storage,
remote control and monitoring, compliance with FDA 21 CFR Part 11, and validation
of analytical methods. For details, visit http://www.agilent.com
or http://www.labtronics.com.
Rosetta Biosoftware and Agilent Technologies
Announce First Gene Expression Data Analysis System to Support Compliance
with 21 CFR Part 11
Rosetta Biosoftware, a leading provider of bioinformatics solutions, and
Agilent Technologies Inc have announced the introduction of Rosetta Resolver
system, version 4.0. This new gene expression data analysis system, used
to analyze genes for disease research and drug discovery, is the industry's
first to support compliance with the U.S. Food and Drug Administration's
(FDA) 21 Code of Federal Regulations (CFR), Part 11. The FDA regulation
requires companies using computerized technologies and systems to manage
electronic data involved in the research, manufacture or management of any
FDA-regulated product to provide documented evidence of data compliance
and verification that the system secures the regulated data. The Rosetta
Resolver system, which is used to store, manage and analyze gene expression
data, enables pharmaceutical and biotechnology companies to comply with
21 CFR Part 11 by providing key electronic data management capabilities,
such as electronic audit trail ; advanced security; accurate and complete
copies; and, documentation to support compliance. Furthermore, Rosetta Biosoftware's
Professional Services can customize the Rosetta Resolver system to meet
customers' specific electronic signature requirements. For details, visit
http://www.rosettabio.com or http://www.agilent.com.
Agilent Technologies to Provide Probe Sequence
Information Derived from Incyte Genomics to Microarray Customers
Agilent Technologies Inc. has licensed the proprietary Incyte Genomics probe
sequence and annotation information used in the creation of Agilent cDNA
and oligo-based microarrays. This information will now be made available
to Agilent microarray customers for the first time. Prior to this announcement,
access to this proprietary and highly valued information underlying Agilent's
microarrays was formerly available only to customers of Incyte's LifeSeq
Gold, LifeSeq Foundation, and ZooSeq content databases. Several previous
agreements between the two companies have provided Agilent access to Incyte
cDNA clones and database content for the purpose of designing gene probes
on Agilent microarrays and key intellectual property related to microarray
manufacture and sample preparation. With this new agreement, Agilent microarray
customers will, at no additional expense, have enhanced sequence annotation
based upon the Proteome BioKnowledge Library Title Line, including the related
protein structure, function, and disease-association information, hand-edited
from the scientific literature. In addition, customers will have password-protected
access to microarray probe sequences for each gene probe. This will benefit
a large customer base using Human 1, Human 2, Mouse, and Rat cDNA Catalog
Microarray Kits. Future 60mer catalog oligo microarrays that use Incyte
sequences are expected to include this feature. Current customers of Agilent
microarrays can receive additional information about obtaining expanded
access to the Incyte content at www.agilent.com/chem/DNA. The new sequence
and annotation information will be added into current products and is already
being applied in the development of new microarray products. For details,
visit http://www.agilent.com.
Agilent Technologies Announces Free E-Seminars
Explaining the Recovery, Purity and Mass-Based Fraction Collection Aspects
of Preparative HPLC
Agilent Technologies Inc. will offer a series of free e-seminars about preparative
HPLC. The first e-seminar explains the enormous importance of high recovery
and purity of samples and demonstrates how to optimize the purification
process. The second seminar explains how mass-based fraction collection
adds significant efficiency to the purification process by allowing the
user to collect only the target masses of interest in a synthetic mixture.
This particular series of e-seminars features the Agilent 1100 Series purification
systems. These systems are highly scalable, single-vendor solutions that
deliver microgram to gram quantities of purified sample from a wide range
of types and matrices. The convenient, 60-minute online seminars are designed
to keep chemists up to date with the latest technology and developments.
The seminars can be accessed anywhere, using a telephone and a computer
with Internet access. To access the e-seminars, go to http://www.agilent.com/chem/purification.
Agilent Technologies Easy View LC/MS Data
Browser Software Simplifies Data Review for Drug Discovery
Agilent Technologies Inc. has announced Agilent Easy View LC/MS data browser
software for synthetic chemistry and related drug discovery applications.
The software allows chemists served by a central analytical laboratory to
easily review chromatographic and mass spectral data from their own laboratory
or office instead of having to return to the lab where the analysis was
run. They can then quickly determine if adjustments are needed in the synthesis
process. The software displays comprehensive purity results; allows side-by-side
comparison of spectra from two samples; loads data quickly; and, views file
formats from other vendors. The Easy View LC/MS data browser software is
designed specifically to integrate with Agilent's Purify and Easy Access
solutions for drug discovery labs. The software (G2727AA) is expected to
be available in the US in December, with prices starting at $2,000 for a
three-seat license. For details, visit http://www.agilent.com.
Scientific Software Announces New RS232 Interfacing
Solutions for CyberLAB Knowledge Engineering System
Scientific Software, Inc., a leader in providing software solutions to the
scientific community, has announced that they have selected LimsLink and
Nexxis software applications from Labtronics Inc. as interfacing solutions
for transferring RS232 data to their CyberLAB Knowledge Engineering System.
This provides CyberLAB users with a choice of solutions for the full integration
of data from RS232 based instruments. LimsLink provides secure management
of the most complex data streams, combined with the ability to include sample
information from the LIMS with the raw data from the instrument. Additional
processing and calculations can be carried out on the data within LimsLink,
before a report is generated and sent to CyberLAB. In this manner, LimsLink
acts as a "data system" for RS232 based instruments that do not
have their own application for formatting and reporting data. LimsLink includes
all of the security components required to meet 21 CFR Part 11 compliance
requirements. The Nexxis Information Integration System provides a data
system for small instruments such as balances, pH meters, etc., that also
documents and controls the execution of SOPs for these instruments, ensuring
that every SOP is followed exactly as written. User definable methods automate
the SOP - collecting data from the instrument, prompting the analyst through
each step, performing any required calculations and preparing a report for
CyberLAB. 21 CFR Part 11 compliance requirements can be met with the full
integration of electronic signatures, password protection and audit trail
into the Nexxis solution. For details, visit http://www.labtronics.com
or http://www.scisw.com.
Patheon Chooses NuGenesis Scientific Data
Management Solution
Patheon Inc., a leading global provider of drug development and manufacturing
services, has chosen the NuGenesis Scientific Data Management System (SDMS)
for its Pharmaceutical Development Services (PDS) and QC operations. Initially
the NuGenesis SDMS will be installed at three of Patheon's Toronto-area
sites. NuGenesis SDMS accurately and automatically captures, catalogs and
stores lab instrument data and information from business applications and
facilitates the seamless integration of information across functional groups
within an enterprise. The system will provide Patheon with easy access to
data and documentation to facilitate the creation of consistent and comprehensive
regulatory submissions. Patheon plans to leverage the NuGenesis SDMS platform
to reduce cycle time. For details, visit http://www.nugenesis.com
or http://www.patheon.com.
Zymark Workstations Installed at TNO Collaboration
to Launch Biological Material Discovery Service
Zymark Corporation, a leading provider of automation solutions servicing
the life sciences industries, has announced that two Zymark lab automation
workstations will be used to launch a service for discovering, developing
and manufacturing biological reagent products by the collaboration formed
between Dyadic International and The Netherlands' Organization for Applied
Scientific Research (TNO). The Dyadic-TNO joint collaboration will use the
Zymark automation platforms in conjunction with Dyadic's fungal, high-throughput
screening and expression systems to significantly accelerate the process
of going from a target gene discovery to manufactured protein product. The
new service will eliminate many of the bottlenecks inherent in other technologies
previously used to bring new gene product to market. For details, visit
http://www.dyadic-group.com or
http://www.zymark.com.