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will host an informational webcast on December 10 on the topic of Laboratory
Information Management Systems (LIMS). This webcast is entitled "Spotlight
on the Meat & Poultry Industry". This event is ideal for lab
operations or QA/QC managers working for meat and poultry processing firms and
commercial food testing laboratories. In the webcast, ATL will focus on
the challenges faced by meat and poultry processing firms. These include:
Critical need for ensuring a safe food supply through improvements in laboratory
efficiency and data quality; Using a LIMS to ensure HACCP (Hazard Analysis and
Critical Control Point) compliance; Need to eliminate manual data entry and
associated data transcription errors by interfacing laboratory instruments to
a LIMS; Ability to provide complete trace back capabilities from farm to table;
Need to have real-time access to food quality data and trends and be automatically
alerted to potential out-of-compliance situations; Using a LIMS to reduce operational
costs and increase product shelf life and profitability. The webcast will be
held from 1:00pm - 2:00pm EST; 12:00pm - 1:00pm CST; 11:00am - 12:00pm
MST; and, 10:00am - 11:00am PST. For details, visit http://www.atlab.com.
To register, visit http://www.clicktoattend.com/?id=133433.
PerkinElmer, Inc. has
announced an alignment of its businesses reflecting the Company’s commitment
to create a healthier, cleaner and safer world. As of January 1, 2009, PerkinElmer’s
businesses will be focused into two strategic areas – Human Health and
Environmental Health. To capture the essence of this alignment, PerkinElmer
is introducing new branding to better reflect the identity and values of the
Company. One element of this will be the new tagline, “For the Better,”
representing the Company’s commitment to achieve its mission of improving
the health and safety of people and their environment. "This announcement
recognizes PerkinElmer’s focus on the important outcomes enabled by
our technologies,” said Robert Friel, the Company’s president
and CEO. “The work we do makes a significant difference in many aspects
of our world- in the quality of our drinking water, how quickly new medical
treatments come to market, the health of newborn babies, and how safe and
secure we feel in our homes. We believe that this clear vision will better
define the strategic mission of the company and improve how we communicate
what we do and the value we deliver to our customers.” PerkinElmer’s
Human Health Business will be based on developing diagnostics, tools and applications
to fight illness, provide better medical insight and more rapidly create critical
new therapies. This business will include the Company’s Genetic Screening,
Bio-discovery and Medical Imaging operating units and will be led by Mr. Friel
on an interim basis. The Environmental Health Business will be based on creating
safer products, more secure surroundings and efficient energy resources. This
business will include the Company’s Analytical Sciences, Laboratory
Services, and Detection and Illumination (formerly known as Sensors and Specialty
Lighting) operating units and will be led by John Roush, who currently leads
the Company’s Optoelectronics business. As a result of the Company’s
decision to focus on human and environmental health, the Company has placed
a portion of its specialty lighting business under strategic review. The estimated
2008 revenue from the businesses under review is approximately $90M. For details,
visit http://www.perkinelmer.com.
Autoscribe Announces UK Business Results for
First Half of 2008, States Continued Growth and Success
Autoscribe has announced a substantial growth of 55% in UK orders for their
Matrix LIMS and related software systems compared to the same period of 2007.
New Matrix systems and licence upgrades business have increased by 42.6% while
support including training has increased by 77.1%. This business growth can
be partially attributed to increased efforts in promotional activities, including
re-working of the web site, resulting in greater awareness of Autoscribe and
its software solutions. The proprietary technology of both web and windows
desktop client operation with one-time configuration of screens and menus
as available with the new Matrix Gemini LIMS is attributed by the company
as another reason for the growth. In addition, the sales team has been strengthened
with more effective follow-up of enquiries and more efforts in terms of presenting
relevant system configurations to potential customers. “The order pipeline
looks strong for both UK and overseas business for the next 6 months so I
am looking forward to continued growth during the second half of our financial
year” says John Boother, Managing Director of Autoscribe Limited. For
details, visit http://www.autoscribe.co.uk.
Tessella Participates in Webinar Addressing
Changing the Status Quo of Drug Development
Optimizing the clinical trial process to increase the chance of clinical and
commercial success is a hot topic across the pharmaceutical industry, as witnessed
by the number and range of attendees at Pharmaceutical Business Review’s
recent webinar ‘Perspective on the future of drug development’.
Nick Bennett, Research & Analysis Director, Healthcare, at Datamonitor,
said: “Pharma is experiencing tough times, facing both economic and
regulatory pressures, with increasing demands for improved safety data and
comparative efficacy studies. A number of strategies can be implemented –
either in isolation, but more effectively in combination – to optimize
the clinical trial process and increase the chance of clinical, and ultimately,
commercial success”. The webinar panels’ experiences of scaling
up to move adaptive trials into the mainstream provided key insight into the
challenges of achieving organizational change, both internal and external,
and what change means from a technology perspective. Professor Don Berry,
of Berry Consultants, stressed the importance of facing changes in strategies
used in drug development. Berry said: “I have been encouraged by the
FDA's Critical Path Initiative which seeks to achieve better outcomes more
cost effectively, such as the use of Adaptive Clinical Trials, the development
of biomarkers, and a growing focus on translational medicine”. Tessella’s
Head of Clinical Trials Solutions, Tom Parke, commented: “As more information
needs to be assimilated and more options opened up in how drug development
can be carried out, the operational processes that support drug development
will become increasingly complex. This poses a major challenge to pharmaceutical
companies to prepare for this new world, as it requires new operating procedures
that traverse existing departmental structures, changes in the skills base,
integrated information management, better information flow and IT infrastructure
to support these new processes”. Parke added: “organizations need
to act now to prepare for these changes.” To listen to a recorded version
of the webinar, please visit http://www.tessella.com/clinicaltechnologies.
Labware Wins Frost & Sullivan Award
Industry analyst Frost & Sullivan has named LabWare as the European Laboratory
Information Systems Company of the Year. LIMS provider LabWare has been increasing
its market share consistently over the years, registering an annual growth
rate of 28.73 per cent for the fiscal year 2007. "LabWare’s ability
to cater to the data management requirements of newer markets such as biobanking
and clinical trials, coupled with investments in novel technologies, will
enable it to sustain its dominance in the European market," states Frost
& Sullivan research analyst Prabakar Sampath. "Moreover, such capabilities
will help the company enhance its overall share in the global LIMS market."
The Frost & Sullivan Award for Company of the Year is presented each year
to the company that has demonstrated unparalleled excellence within its industry.
The award is based on numerous factors including the company's business development,
competitive strategy, customer satisfaction, and leadership within a particular
Frost & Sullivan Industry Research Group (IRG). This company is
perceived to exhibit outstanding management and consistent growth. The company
must offer high quality products and/or services and have positive social
and economic impact on local and national communities. The company’s
customer service offerings and performance are expected to be of very high
calibre. The company should have proven expertise in taking advantage of market
changes by capturing and solidifying market presence, or through execution
of innovative strategies within the existing competitive landscape. For details,
visit http://www.labware.com.
NWA Introduces NWA eHACCP System
Northwest Analytical, Inc. (NWA) has introduced the NWA eHACCP System. NWA
eHACCP is an extension of the NWA Quality Information System that delivers
a complete electronic HACCP data collection, compliant data management and
secure electronic signature for HACCP document production and management.
NWA eHACCP combines process management and improvement with better HACCP compliance.
Studies have shown that active process management and continuous process improvement
enables successful HACCP safety compliance. NWA has expanded its established
plant floor data collection, process management, analytics and improvement
system to encompass HACCP compliant data collection, management and reporting
to deliver a powerful food safety and quality management system. In addition
to a compliant system, the successful eHACCP implementation requires a well
planned conversion plan from the existing paper based HACCP program. NWA has
partnered with Dr. John Surak to develop a conversion plan that includes the
training, validation and verification steps needed to properly implement the
system. These steps are critical to assure regulatory agencies, customers,
and third party auditors, that the electronic HACCP solution is an effective
food safety system. For details, visit http://www.nwasoft.com/ehaccp.htm.
NWA Announces NWA Quality Analytics Server for
Real-Time Plant-Wide SPC and Manufacturing Analytics Reporting
Northwest Analytical (NWA) has announced 
NWA
Quality Analytics Server which provides real-time alerts and SPC charts throughout
the plant for process and quality parameters. Quality Analytics Server
connects to any ODBC-compliant database, monitors any combination of process
parameters, detects product specification and SPC violations and delivers
role specific analytics and reporting. NWA Quality Analytics Servers is designed
for a fast and efficient implementation that provides a plant wide analytics
solution with minimal IT overhead. For companies that already use NWA Quality
Analyst for SPC, existing databases and report set-up can be incorporated
to reduce configuration and training requirements. "Our operators really
like the Quality Analytics ‘dashboard’. It automatically updates
and tells them when to pay attention.” says one Six Sigma manager in
a major chemical firm, “QAS lets them focus on just the one point
that demands attention, and then drill down to reports and charts as necessary."
"NWA Quality Analytics Server is a major step on our path to deliver
our vision of Manufacturing Analytics to our clients,” says Cliff Yee,
CEO of Northwest Analytical. “With NWA Quality Analytics Server, process
visibility can reach any part of the enterprise." For details, visit
http://www.nwasoft.com/qas.htm.
QSI Integrates MRP with LIMS as a Rental Solution
for Cost Sensitive SMEs
To give manufacturing companies an affordable opportunity to optimise efficiency,
QSI has unveiled its new WinLims For Manufacturing Rental solution that provides
a LIMS software package that is fully integrated with a Materials Resource
Planning (MRP) tool.The new rental solution is aimed principally at small
to medium enterprises (SMEs) that do not already have a MRP or Enterprise
Resource Planning (ERP) system. The QSI WinLims For Manufacturing Rental package
is a specially designed version of the company’s popular WinLims that
supports fully integrated MRP functionality to offer smaller enterprises significant
cost savings. Those enterprises opting for the rental solution are able to
conserve their capital and simply pay for the LIMS and MRP capabilities out
of their income revenues. The whole rental package is tax deductable. The
integrated solution offers SMEs the economic benefits of rental plus the cost
saving benefits of having a single data entry point for shared LIMS and MRP
data, reduced duplication of data and the prospect of fewer transcription
errors, increased flow of data between systems, plus overall increased efficiencies
in business processes and workflow. For details, visit http://www.qsiuk.com.
RTS Life Science Announces New Technical Paper
Discussing Volume and Precipitate Identification of Samples in Storage
RTS Life Science, 
a
worldwide supplier of automated sample management and drug delivery testing
systems, has announced the availability of a new free of charge technical
paper about the analysis of sample volumes in a store. Entitled "Applying
Vision Technology to Calculate the Volume of Sample in a Tube", the informative
poster discusses the benefits of RTS' innovative vision system technology.
Presented for the first time at the Drug Discovery 2008 conference in September,
2008, the technical poster describes how RTS partnered with a major pharmaceutical
company to upgrade its tube store with a vision system that routinely and
accurately audits tubes to calculate sample volumes and identify any particulate
matter. Calculating the precise volume of a residual sample in a tube has
always been an inexact science. Traditional methods include weighing, software
or manual analysis. All of these techniques can prove both time consuming
and inaccurate. RTS Life Science's technical paper demonstrates how a large
pharmaceutical company eliminated these lengthy approaches by incorporating
novel vision system technology into its sample store. Using a camera mounted
in the store, RTS implemented an image analysis stage between sample storage
and picking that allowed the volume of liquid in the tubes to be calculated
to an accuracy of +/- 10ul. By applying vision technology to its tube store,
the pharmaceutical company can now be confident about the volume of samples
in the tubes it receives. As well as eliminating previous lengthy manual steps,
the unique vision system technology also alerts the customer to tubes where
compounds have precipitated out of solution. The poster is available free
of charge in downloadable pdf format via http://www.rtslifescience.com.
Additional Changes to GMP Regulations Are Under
Development
Now that the FDA has completed the first part of changes to its GMP regulations,
work on more significant modifications is under way. The first phase of the
GMP revisions takes effect December 8, 2008 and includes changes in the requirements
for verifications of critical production steps and a mandate to validate aseptic
processes. Stricter GMP requirements for the pharmaceutical industry are likely
as large-scale recalls and compliance issues have prompted congressional investigations,
according to the FDA. For details, visit http://www.fda.gov.
FDA Issues Test Guidance for Cellular, Gene
Therapies
According to a new draft guidance, companies are advised to use an incremental
approach to developing product-characterization tests for investigational
cellular and gene therapies because they are complex and can present significant
challenges in establishing potency assays. The tests used as appropriate measurements
for potency will vary depending on the characteristics of a specific cellular
or gene therapy product. For details, visit http://www.fda.gov.
GAO Says FDA
Must Increase Inspections of Foreign Drug Firms
While the FDA's establishment of offices abroad may improve its oversight
of foreign drugmakers, it is too early to tell whether the move will be effective
or increase the number of overseas inspections, a new Government Accountability
Office (GAO) report says. The FDA does not take violations of good manufacturing
practices as seriously in foreign companies as it does in domestic companies,
according to the report, which recommends the agency increase its inspections
overseas to match the number of its U.S. inspections. For details, visit http://www.fda.gov.
FDA Is Considering REMS for Opiate Drugs
The FDA is considering implementing a risk evaluation and mitigation strategy
(REMS) for opiate drugs, but the issue is still in flux. Risk management plans
are in place for most of the potent opiates, such as surveillance programs
and distribution of educational materials, but implementing an overarching
REMS for such products is a difficult task that would take some time to complete,
Bob Rappaport, director of the FDA’s Division of Anesthesia and Rheumatology
Products, said. For details, visit http://www.fda.gov.
FDA
Reviews of Promotional Materials Grow With Hiring
The hiring of 12 new reviewers for the FDA’s Division of Drug Marketing,
Advertising and Communications is allowing the agency to beef up its scrutiny
of drugmakers’ promotional materials. There has been a marked increase
in the number of warning and untitled letters sent to drugmakers in the past
few months. The FDA said it has a greater capacity to review promotional pieces
because of staffing increases, but the agency did not say a recent spate of
regulatory letters was a direct result of taking on new staff. For details,
visit http://www.fda.gov.
State of Massachusetts Cuts $10 Million From
Biotech’s Billion
The state has cut $10 million from this year’s disbursement of its ambitious
$1 billion in biotech industry and research incentives, according to a spokesman
for the Massachusetts Life Sciences Center (MLSC), the agency that awards
the funds. The cut was confirmed this week and the enabling legislation is
now on Gov. Deval Patrick’s desk. Because it faced falling tax revenue,
the state Legislature included the reduction as part of an emergency budget
passed the first week of November 2008. Despite the economic downturn, Susan
Windham-Bannister, president and CEO of the MLSC, has affirmed publicly the
life sciences initiative will continue. As evidence, the center’s board
approved the first infrastructure disbursement on October 31,2008, awarding
the town of Framingham a $5.2 million grant to improve its water and sewer
system to support Genzyme Corporation’s planned expansion there. The
Massachusetts Life Sciences Act, a hodgepodge of grants, tax breaks, loans,
and other incentives designed to bolster the state’s biotech sector
over the next 10 years, was signed into law by Patrick on June 16, 2008. The
$1 billion will be distributed in a variety of ways: $500 million is slated
for capital improvements; $250 million is available in tax breaks, capped
at $25 million a year; and some $250 million is part of an investment fund
that will pay out $25 million a year, at the center’s discretion. With
the cut, that amount will be $15 million in 2008, and is expected to slow
the MLSC’s abilities to offer grants and loans. Not affected will be
the MLSC’s daily operations, the state’s tax incentive program
(which goes into effect January, 2009), or the infrastructure grants. For
details, visit
http://www.masslifesciences.com.
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