The following is a wrap-up of news of interest during
the months of January to February 2001.Taratec Develops New Solution to Help Life
Sciences Industry Comply with FDA's 21 CFR Part 11 Regulation
Taratec Development Corporation has launched the Taratec e-Compliance (TeC)
solution, enabling companies to securely manage data files from virtually
any source. Specifically designed to address the FDA's electronic records
and signatures rule, 21 CFR Part 11, TeC provides life sciences laboratory
and manufacturing facilities with a low-cost, scaleable solution that supports
a full audit trail of all file and system administration activities. Issued
by the FDA in 1997, 21 CFR Part 11 provides criteria to ensure the data
integrity and security of e-records and e-signatures used in all FDA program
areas, permitting the widest use of electronic technology while protecting
public health. TeC seamlessly integrates into most existing computer systems
and is non-invasive to data sources or applications. Systems supported include
laboratory instrument data collection applications, data entry applications,
and electronic batch record systems as well as Excel spreadsheets and Word
files. Accessible through a Web browser, TeC stores all files p; from
raw data to Certificates of Analysis p; in a secure, central location
with a full audit trail. Building on the industry standard Oracle8i platform,
TeC provides the security and reliability of a Relational Database Management
System (RDBMS) along with ease of use associated with standard file systems.
For details, visit, http:// www.taratec.com
Accelerated Technology Laboratories Joins
Compaq Agent Program
Accelerated Technology Laboratories, Inc. (ATL) has announced a new
partnership with Compaq compures as part of their agent program. ATL makes
SampleMaster Pro LIMS. Compaq is known for its computer products, services,
and solutions. As a Compaq agent, ATL can assist customers in implementing
their hardware requirements faster and easier by recommending the necessary
components for them, such as servers, workstations, storage options, and
printers. For details, visit http://www.atlab.com
NuGenesis Technologies Introduces Enhanced
Support for Millennium Software
Waters Corporation and NuGenesis Technologies Corporation are teaming together
to alleviate the complexity associated with archiving and retrieving large
amounts of data specifically to address the FDA's 21 CFR Part 11 rule. Known
as the electronic records and signatures rule, 21 CFR Part 11 imposes guidelines
on pharmaceutical companies archiving test results in a regulated environment.
The NuGenesis Scientific Data Management System (SDMS) software extends
the capabilities of Waters' Millennium software by providing scientists
a means of automatically and securely archiving full projects or incremental
results to a variety of media/drives. For details, visit http://www.nugenesis.com
or http://www.waters.com
Thermo LabSystems Introduces New Brochure
on Nautilus LIMS
Following the recent launch of Nautilus 2000 Release 2, Thermo LabSystems
has published an updated eight-page brochure. This new Nautilus brochure
provides a comprehensive overview of functionality, user benefits and Thermo
LabSystems' available implementation, training and support service. In the
first two years since its launch, Nautilus has over 100 installations at
customer sites in 15 countries around the world and over 1,600 concurrent
users run Nautilus in both regulated and non-regulated laboratory environments.
The new full-color brochure includes descriptions on all the latest Nautilus
features and its underlying technology. The brochure is available free-of-charge
worldwide by calling +1 800 719 1853 , or emailing info@thermolabsystems.com
Applied Biosystems Device Receives IDE from
FDA
Applied Biosystems Group has announced that the US FDA's Center for Biologics
Evaluation and Research has approved an Investigational Device Exemption
(IDE) for their ViroSeq HIV-1 Genotyping System. This IDE authorizes Applied
Biosystems to use the ViroSeq system in further clinical trials involving
HIV-1 resistance testing of HIV-1 infected patients. Applied Biosystems
is also currently conducting clinical trials to prepare the ViroSeq HIV-1
Genotyping System for a 510(k) submission to the FDA that would seek market
clearance of the system as an in vitro diagnostic tool with a Class II Medical
Device designation. The company designed the separate parallel IDE clinical
trials so that they would yield data for a subsequent 510(k) submission
with the goal of expanding the use of the product into new clinical diagnostic
uses. For details, visit, http://www.applera.com
LIMS Mailing List Updated and Search Capability
Added
The LIMS Mailing List now has a search capability added to the web archives.
This search function to the list web archives required a change in the presentation
and organization of the html archives. Now users will be able to find information
more quickly and easily than before. To test the function, visit http://www.users.fast.net/~millers/lims.html
and follow the link to the FAQ or the LIMS Mailing List archives as "lims-faq.txt".
Or go there directly by visiting, http://lims.taratec.com/cgi-bin/wilma/lims
See the 'GET' commands below for instructions on how to retrieve files from
the list archives. This FAQ is also posted on or about the 1st of each month
to the LIMS Mailing List. For more information on the LIMS Mailing List
and other similar resources, visit the LIMSource
User Community pages.
New Intelligent Detectors Determines Off-Flavors
and Odors
A new gas sessor array system from WMA Airsense as well as electronic noses
for process control applications and enrichment devices will be highlighted
at the upcoming Pittsburgh Conference. The control of food quality (spoilage,
rancidity, off-flavors), the detection of residual solvents or odorous compounds
in packaging materials (plastic odor in bottles), the supervision of industrial
processes (leakage control) or environmental applications (monitoring of
malodor) can be performed in a fast and easy way with gas sensor arrays,
which are known as electronic noses. Gas sensor array systems from simple
sensor array units (OEM) to systems with sophisticated sampling methods
will be highlighted in the WMA Airsense booth. A novel combination of enrichment
device (trap) with the intelligent detector will also be presented. Visit
booth # 7212.
Innaphase Corporation Announces Acquisition
of Pharmaceutical Software Systems, Inc.
InnaPhase Corporation, a leading provider of software solutions for early
pharmaceutical research and development, announced the acquisition of Pharmaceutical
Software Systems, Inc. (PSS), provider of a protocol-driven, GLP-compliant,
LIMS for DMPK/Bioanalytical applications. PSS's LIMS, called Watson, fully
supports and facilitates the drug development process during pharmacokinetic
and drug metabolism/ bioanalytical studies. With the acquisition of PSS,
InnaPhase is now positioned as the only provider in the world of protocol-driven
systems offering an end-to-end solution for early drug development (EDD)
processes, including laboratory sample management, PK/PD analysis, simulation
and integrated reporting, all within a tightly controlled GLP framework.
The Watson program manages the entire drug study cycle from study design,
assay design, sample handling, shipment tracking and analytical run planning.
It also controls instrument interfaces and regression of standards, analytical
performance reports, GLP evaluation, basic PK calculations, sample results
in both table and graph formats, and the creation of flexible user defined
reports. "A strategic partnership forged in 1999 allowed InnaPhase
and PSS to share information and technology for early drug development"
said Peter J.D. Ryan, President and CEO of InnaPhase Corporation. "This
relationship worked so well that both companies felt we could better apply
our vision for technology and offer our customers much higher value as a
combined company. With this acquisition and the recent acquisition of SciSoft,
a former software division of Phoenix International, InnaPhase is able to
leverage substantial customer feedback with our extensive technology in
both the USA and EC to ensure that our solutions meet all our customers
needs and stay ahead of competition." For more details, visit http://www.innaphase.com
Taratec and Waters Corporation Sign Agreement
to Offer Millennium32 Software Users Comprehensive LIMS Services
Taratec Development Corporation, a provider of integrated e-technology and
regulatory solutions for the life sciences industry and Waters Corporation,
a leading manufacturer of high performance liquid chromatography (HPLC)
and mass spectrometry (MS) technologies, announced that they have signed
a cooperative marketing agreement in which both companies will participate
in joint sales and marketing activities. Under the terms of the agreement,
Waters will recommend Taratec's professional consulting services to its
clients that request assistance in integrating Waters Millennium32 Chromatography
Software with a LIMS or when a client requires assistance in developing
a laboratory automation solution based on the Millennium32 Developer's Toolkit.
"This partnership allows Taratec to provide Waters' customers with
tightly integrated laboratory solutions that offer strategic and competitive
advantages," said Mark Kolb, president and CEO of Taratec. "It
is also representative of Taratec's commitment to helping companies in the
life sciences industry analyze work flows, build and integrate solutions,
and validate the associated systems, including compliance with the FDA's
21 CFR Part 11 regulation." Taratec and Waters have worked together
on many Millennium32 software projects, designing and building custom interfaces
to LIMS, providing a seamless suite of chromatography sequence creation,
instrument monitoring, process control and data analysis tools for the laboratory.
For more information, visit http://www.taratec.com
or http://www.waters.com.
Thermo LabSystems at Pittcon 2001
With a number of new product offerings and significant strategic alliances
to announce, Thermo LabSystems appears set to generate a great deal of interest
at the upcoming Pittsburgh Conference from March 4-8 2001 in New Orleans,
LA, USA. Among the highlights will be:
(1) Solution for Bio-informatics - Thermo LabSystems will be presenting
demonstrations of a new solution for the first time in a public arena. As
a result of strategic worldwide partnership agreements with several major
biotechnology/pharmaceutical companies, with academia and with Spotfire
Inc, Thermo LabSystems will be presenting new capabilities in the areas
of micro-array data handling and data visualization.
(2) New Chromatography Data System (CDS) for single workstations - Thermo
LabSystems will be launching its high specification A2D (analog to digital)
acquisition device for chromatography data. This latest innovation means
its award-winning Atlas CDS can now be cost-effectively deployed in both
workstation and client/server environments (from 1 to 1,000 channels).
(3) Enhanced integration solutions for SampleManager LIMS p; Thermo
LabSystems will be introducing the latest interface developments between
its flagship enterprise LIMS and SAP's R/3 Enterprise Resource Planning
System and the OSI PI Plant Information System.
For more information, visit booth # 4552 or e-mail info@thermolabsystems.com
LIMS Symposium Slated at Pittcon 2001
Steve O'Connor of Whitehall-Robins Health Care and Gerst Gibbon of the LIMS
Institute will be presiding over a LIMS Symposium entitled "LIMS: Real
Problems, Real Solutions" on Tuesday, March 6 at the Pittcon 2001 Conference
in New Orleans, LA. The symposium will showcase LIMS which address the problems
confronting laboratories today: interfacing with Enterprise Resource Planning
systems, electronic recordkeeping and electronic signatures, successfully
implementing and using very large databases, and effective LIMS project
planning and implementation. The invited presentations and speakers include:
"You Press The Button; We'll Do The Rest - A Case History of LIMS
In Kodak's European R&D Laboratories", John Trigg, Kodak R&D
Laboratories, Harrow, UK; "A Day in the Life of A LIMS from a User's
Perspective", Michael F. Delaney, Massachusetts Water Resources
Authority; "Experience With SAP/LIMS Interfacing", David
Williamson, SAP Project Team, Wyeth-Ayerst Pharmaceuticals; "LIMS
and GENES: Not Just a Sample, More a Way of Life", Gina Kearsey,
Dataware Warwick; and, "LIMS Project Management: The Twilight Zone:
A Case Study of Two LIMS Projects", Steve O'Connor, Whitehall-Robins
Health Care. For details, visit http://www.pittcon.org
Institute for International Research to Host
a LIMS Conference on Effectively Implementing a Compliant System
The Institute for International Research will be presenting a new LIMS Conference
entitled LIMS: Effectively Implementing a Compliant System from April
25-27 at Caesars Palace in Las Vegas, NV. The conference will feature prominent
professionals in the field who are leaders in interpreting FDA guidelines,
implementing validation procedures, and establishing new and efficient processes
qualification methods. The conference also offers a workshop on LIMS software
entitled "What to Expect from a Vendor Audit" as well as two case
study tutorials entitled "Replacing a LIMS Legacy System" and
"Achieving Successful LIMS Information Management While Meeting Quality
Standards." For further information, contact Diane Krusko, VP Pharmaceutical
Division, (212) 661-3500 X3732. To register, call: IIR at (888) 670-8200
in the US; +1 (941) 951-7885 Int'l. Reference code # XP0628LST. For more
information, visit http://www.iir-ny.com/conference.cfm?EventID=p0628
Beckman Coulter Highlights Biotech Solutions
at LabAutomation 2001
Beckman Coulter will be highlighting their biotechnology solutions at the
upcoming LabAutomation 2001 Conference in Palm Springs at the end of January.
In addition, they will be presenting a free workshop on Tuesday, January
30, from 12:30-2:00 at the Wyndham Hotel entitled "Chat with the Masters,
and Interactive Forum on Beckman Coulter Laboratory Automation Software".
Just sign up at the Beckman Coulter booth at the conference. For details,
visit http://www.beckmancoulter.com
or http://www.labautomation.org
Beckman Coulter to Show New LabManager iLIMS
Software at Pittcon 2001
Beckman Coulter will highlight their new LabManager iLIMS LIMS at Pittcon
2001 in New Orleans, LA from March 5-8. This reengineered LIMS offers navigation
advances and greater flexibility, including the option to access the system
from an Internet web browser or a client/server Microsoft Outlook-styled
user interface. The system is a native Oracle8 application that provides
complete sample, test, and data management on a Windows NT/2000 or HP9000
server. The software can also make use of Microsoft Visual Basic to automate
processes and customize applications, data formats, and calculations. iLIMS
also supports Seagate Software's Crystal Reports tool for custom report
design. For details, visit http://www.beckmancoulter.com/LIMS
New Pinnacle Chromatography Data System (CDS)
from Beckman Coulter to Highlight Electronic Signatures at Pittcon 2001
Beckman Coulter will showcase the new version of their Pinnacle CDS at Pittcon.
The new version includes features which help pharmaceutical companies meet
the requirements of the FDA's 21 CFR Part 11 electronic signatures and records
rule. Pinnacle Version 1.1 can maintain an audit trail for every document,
recording time, ful user name, certified electronic signature, and old/new
values for each change. To accommodate individual site requirements, system
administrators can specify whether an electronic signature is required for
specific actions, such as create, modify, rename, review results, etc. A
built-in security system provides tight control over authorization to create
and modify documents. As an added safeguard, the system requires that passwords
be changed at regular intervals and prohibits their reuse within a specified
period of time. For details, visit http://www.beckmancoulter.com/LIMS
NuGenesis Technologies and Smart Storage
Team Up to Provide Data Capture, Storage, and Retrieval Solution
NuGenesis Technologies and Smart Storage Inc., a provider of standards-based
on-line data storage software, have announced the integration of the SmartStor
Archive with NuGenesis' Scientific Data Management System (SDMS). SmartStor
Archive and NuGenesis SDMS provide an integrated solution for data capture,
storage, and retrieval. Using the SmartStor Archive interfase, NuGenesis
is able to provide a secure and seamless platform for scientists seeking
a solution for their data management and records compliance needs. For details,
visit http://www.nugenesis.com.
Crystal Group Servers Pass PFC Certification
Crystal Group Inc., a leading provider of integration services and high-density
servers for Internet and telephony applications, has announced that their
line of space-efficient servers has passed Power Factor Correction (PFC)
certification. The Crystal servers included in the certification are as
follows: RIA, CS500, CS600, CS900 and CS1000. PFC certification of power
supplies is mandatory in the European union as of January 1st, 2001. PFC
shifts current in a power supply and balances the load by ridding the supply
of apparent or non-working power and allowing for more working power within
the unit. PFC power supplies create less stress on a circuit breaker or
UPS and generate less heat and noise in components involved in AC mains
distribution. For details, visit http://www.crystalpc.com.
Zymark Corporation Introduces Twister II
Advanced Capabilities Microplate Handler
Zymark Corporation has introduced Twister II, an advanced microplate handling
system that adds more functions to the already successful Twister system,
allowing greater capacity, faster transport, and the ability to access the
x-y index positions of almost any liquid handling deck. This low-cost microplate
handler can serve as the hub for a new breed of "Mini-Systems"
to provide users with a time-saving alternative to stackers and a money-saving
alternative to larger, more complex integrated systems. For details, visit
http://www.zymark.com
Zymark Announces Partnership with Bayer Corporation
Zymark Corporation has announced a partnering of resources with Bayer Corporation
to provide laboratories with an automated platform for cell-based compound
screening. The assay solutions package, developed in response to customer
needs, runs Bayer's QuanitGene assays on Zymark's Staccato Workstation.
The package includes Bayer's QuanitGene HV Kit and ProbeDesigner Software,
as well as Zymark's Staccato application workstation. The combination permits
laboratories to choose any gene target and cell type, and design and run
cell-based assays in an automated format. For details, visit http://www.zymark.com
Agilent Technologies Broadens its Capillary
LC Solutions with New 1100 Series Micro Well-Plate Autosampler
Agilent Technologies has introduced a new module that extends the current
offering for the Agilent 1100 Series capillary LC system which was introduced
in March 2000. The Agilent 1100 Series micro well-plate autosampler adds
higher flexibility and fast injection cycles to the system. The new module
offers injection volumes ranging from nanoliters up to microliters. Its
injection speed is also considerably faster than the Agilent 1100 Series
micro autosampler's. It is available worldwide and can be ordered through
any Agilent Technologies chemical analysis product sales office. The non-thermostatted
version is priced at $16,320 while the thermostatted version is $20,480.
Delivery is estimated at 12 weeks from receipt of order. For details, visit
http://www.agilent.com
Waters Corporation to Hold 15th International
Millennium Users Forum
Waters Coprporation will hold their 15th International Millennium Users
Forum from June 5-8 at the Hilton Oceanfront Resort in Hilton Head, South
Carolina. Forum discussions will include regulatory compliance, system management,
applications, 21 CFR Part 11, optimizing the Millennoum Server, and more.
If you are a user and are interested in presenting a paper, please email
a brief abstract (in MIcrosoft Word) by January 30 to tom_hall@waters.com.
For details and to register, visit http://www.waters.com/millennium32