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STARLIMS
Customers Discuss Enterprise
Traceability and Integration
Orlando 2005, Conference Notes
STARLIMS Corporation recently held their 2005 Users
Group Meeting in Orlando, Florida in conjunction with the PITTCON
Exposition. A highlight was the first public introduction of STARLIMS
Version 10 Web-based LIMS, utilizing the scalability of Web Services. The
conference focused on the importance of standardization, traceability and
integration across the enterprise.
A 2 day program attracted the largest attendance ever
with nearly 200 attendees from around the globe. The group was
significantly more diverse than previous years with attendees from the
government and public heath sector complementing the traditional attendees
from the manufacturing space. The fight against terrorism and disease is
spurring users to upgrade archaic manual reporting systems to enterprise
integrated LIMS to provide the right information to the right people and
systems when they need it.
Topic presentations were augmented with STARLIMS User
Presentations on anticipated, active, and completed implementations
covering a range of industries and business environments.
LIMS
ADOPTION WITHIN A GLOBAL ENTERPRISE
Dale Nordenberg, MD, from the National Center
for Infectious Diseases, CDC, and Office of the National Coordinator for
Health Information Technology at the HHS, discussed technology adoption
challenges within an enterprise with global boundaries such as the CDC and
affiliated programs across the globe. Dr. Nordenberg emphasized the need
to focus on sustainable information infrastructures and the role of the
STARLIMS community working together to provide a critical ‘laboratory’ to
identify and solve important informatics challenges.
MULTI-STAKEHOLDER
STANDARDIZATION
Wanda
Andrews from the Division of Consolidated Laboratory Services,
Commonwealth of Virginia revealed one of the largest LIMS-based
undertakings to-date aimed at creating common “out of the box”
configurable functionality to support a wide range of multidisciplinary
processes consistent with guidelines set forth by the Association of
Public Health Laboratories. The project (known as “Sunrise”) is based on
an ongoing collaboration of state and county public health agencies across
the US. Ms. Andrews’ presentation explored the key elements necessary for
a successful LIMS collaboration driven by multiple stakeholders including
the need for an agreed upon standard, a well-defined scope, good project
management, adequate funding and resources and last but not least
stakeholders that share common goals, a high level of commitment, a
willingness to compromise and the ability to look beyond today’s business
needs.
VERSION
10 AS A TECHNOLOGY ENABLER FOR CENTRALIZED DEPLOYMENT
Jeffrey
Allen at the US Air Force Petroleum Office’s (AFPET) announced the Air
Force’s decision to partner with STARLIMS in adapting the new Version 10
software to provide a fully functional LIMS system which supports a
worldwide customer and laboratory structure and a deployed laboratory
asset, all with centrally controlled architecture. The US Air Force
Petroleum Office offers world wide quality support to over 200 locations
using six area laboratories in the Ohio, Florida, California, the UK,
Japan and Qatar. Mr. Allen illustrated how the current reshaping of the
Air Force from a “cold war” stationary deterrent force to a mobile, rapid
deployment force has greatly influenced their decision to migrate to a
modern LIMS technology that is able to support the Air Force’s deployable
mission requirements and provide timely, worldwide customer access to
critical analysis results
THE
ROI OF A 2,500 USER STANDARD LIMS
Jerry
Telles, at the Global Downstream IT division of ChevronTexaco,
presented the ROI of a standardized 2,500 user STARLIMS implementation. As
a large organization with multi-laboratory facilities, ChevronTexaco
recognized the need and potential benefits of adapting an integrated
approach in selecting a LIMS. Since December 2003, the five refining
sites across North America run STARLIMS as an essential component of the
enterprise IT strategy. The standardization project covered the
development of consistent procedures, processes and methodologies.
Activities were aided by single detailed appropriation requests and
corporate licensing agreements. Notwithstanding the challenges associated
with establishing the standardized LIMS, the financial and operational
benefits are evident. Cost benefits increase as new sites are added with
STARLIMS being rolled out to ChevronTexaco international plants.
REGULATORY
CONCERNS IN A MULTI NATIONAL DEPLOYMENT
David
Dasso contractor to the Department of Defense, Medical Research
Information Technology System (MeRITS) outlined multi-cultural and
multi-lingual challenges in global LIMS deployments. The Department of
Defense plays an active role as a drug, vaccine & device developer. The
MeRITS office is currently involved in a major effort to address the
rapidly changing regulatory and technological environment which both the
biopharmaceutical industry and the Department of Defense are confronted.
This effort will result in improved regulatory compliance and business
efficiencies to meet the challenges of the global enterprise for today and
tomorrow. Mr. Dasso outlined the phases that will enable standardized
deployment of STARLIMS in all subordinate organizations meeting the needs
of very different research areas. The Armed Forces Research Institute of
Medical Sciences (AFRIMS), based in Thailand was selected as the best
candidate site for conducting the STARLIMS Pilot implementation beginning
with the Virology Department and incrementally expanding capabilities and
functionality to other departments at AFRIMS. Unique process differences
are not the only concern MeRITS encounters, as language, physical
environment, technology infrastructure, local resources and cultural
idiosyncrasies are all factors that need to be addressed in order to
mitigate business and regulatory risk.
10
YEAR TRACK RECORD OF CHANGE
Joseph
Cerminaro and Mark Laney shared Baxter Healthcare Medication’s
10 year track record association with STARLIMS implemented over 5 plants
that manufacture IV bags and solutions. User requirements even among
facilities with very similar manufacturing and quality processes can
differ. This makes the design and ongoing maintenance of a standard system
a challenge. The multi-facility STARLIMS deployment is managed by a
central core team which leverages STARLIMS flexibility to accommodate
local differences configured in the system without having to design
separate systems for each plant. Baxter’s business is highly regulated by
the FDA. In such an environment, adherence to current business rules,
especially for systems used to make quality decisions on products is
critical to the business. Hence, Baxter places high value on the
development of systems which can automate the following of business rules
and help “mistake-proof” the laboratory environment.
ISO
17025 ACCREDITATION ACCELERATOR
Deborah-Ann
van Geelen of Anglo American Research Labs (AARL) described how
STARLIMS aided in automating the lab satisfying ISO 17025 certification
standards. AARL are a division of Anglo American plc, a global mining
company. AARL has 5 laboratories namely Geochemistry, Analytical, Ore
Characterization, Mineralogy and Environmental, which have distinctive but
different workflows. The laboratories analyze samples from various sources
and provide detailed reports on the composition of the samples. The
STARLIMS Project was initiated in 2001 to replace various standalone
solutions such as Microsoft Access and Excel Spreadsheets. STARLIMS
flexibility has been key to the success of the implementation. AARL are
able to accommodate the individual laboratories procedures and create an
overall streamlined process enhancing AARL’s competitiveness, reducing
operating costs and allowing productivity to be more efficiently and
effectively monitored.
EXTRACTING
DATA FROM WATER
Tom
Bushly of the USGS presented a detailed description of STARLIMS role
at National Water Quality Lab (NWQL) in changing water into data employing
STARLIMS traceability functionality. NWQL provides the USGS and the public
with high quality, reliable data to describe and understand the earth's
hydrology through the impartial application of science and technology to
physical, chemical, and biological analyses of water, sediments, and fish
tissue. The NWQL operates an integrated network of 22 servers and 319
workstations providing support to all sections of the laboratory including
lab instrumentation. STARLIMS provides personalized schedules and
worksheets to assist laboratory technicians in satisfying customer
requests for timely analysis. NWQL’s web interface provides customers
access to sample status and billing information anytime day or night, any
day of the week. The current STARLIMS database holds 12.5 million
results, 98% of the data creation is automated and all entries are
monitored by sophisticated error checking mechanisms and audit trails.
USGS is planning future system enhancements taking advantage of the
STARLIMS version 10 web based functionality.
FARM
TO FORK
Jay
Ross from the California Animal Health and Food Safety Labs (CAHFS) at
the University of California, Davis, enlightened the community, of
STARLIMS contribution in the goal to reach true farm to fork traceability.
STARLIMS first deployment at CAHFS is aimed at automating sample analysis
of Bovine Spongiform Encephalopathy (BSE). The mission of CAHFS is to
provide the citizens of California with the highest quality diagnostic
laboratory support service for livestock and poultry disease control,
enhancement of livestock and poultry health management and ensuring the
safety of foods of animal origin. CAHFS plays a pivotal role in the
protection from diseases common to animals and humans, equine health and
performance and the recognition and dissemination of new knowledge.
STARLIMS was selected by the CAHFS due to the fulfillment of automation
requirements, the flexibility in overall architecture, integrated
messaging capabilities, previous experience in a public health environment
and instrument integration features. Key IT issues being addressed are
standards based messaging (PHIN-MS, HL7) and adequate standardization of
data (LOINC, SNOMED). The BSE project is one of the first implementations
of a multi-organizational “program” and involves a combination of systems
and organizations. A Chain of Custody is established early in the process
as is the union of data to the sample. The BSE program further introduced
requirements for data integration using XML and the need for comprehensive
barcode technologies, all of which have been handled seamlessly by
STARLIMS. |