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 LIMS
Markets
Chemical/Petroleum
Clinical
Commercial
Environmental
Food & Beverage
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Life
Sciences
Manufacturing
Public
Health
Water
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 Laboratory Management
System: Life
Sciences and
Pharmaceuticals
Laboratory Management System Introduction
All parts of the Pharmaceutical and Life Sciences
business are under pressure to perform more effectively. Factors such as
rising costs in bringing new drugs to market, limited patent time spans
and increasing competition exert pressure on R&D organizations (including
Clinical Research Organizations) to increase the rate and volume of new
compound development and marketing. To help make informed decisions about
the suitability of compounds throughout the development cycle,
organizations must have access to the accurate data. Many research
organizations also need to manage large-scale compound libraries used for
medium or high-throughput screening, which present their own issues of
sample and information management. At the same time, laboratories must
also ensure the efficacy and safety of drugs; that all work is carried out
in accordance with all relevant regulatory rules and regulations; and that
all the data and information required for regulatory submissions is
readily available.
Organizations responsible for performing the testing
associated with clinical trials face their own laboratory data and
information issues. This may include interfacing with clinical trial
software and clinical analyzers, issues of confidentiality and security of
information, the handling of kits used for testing (preparation, shipping,
receipt and handling within the laboratory), and the reporting of results
in the correct format to the sponsoring organization. Again this has to be
done within the strict regulatory framework imposed on the pharmaceutical
and life sciences business.
Nowhere are the strict regulations and regulatory
framework imposed on the pharmaceutical industry more evident than in the
manufacturing sector. In drug manufacturing, the QA/QC laboratory must not
only ensure that products meet the specified quality requirements, but
they must also ensure that the product, manufacturing process and their
own working practices adhere to the defined regulations. The laboratory
must also ensure that any informatics systems in place are able to
interface with other enterprise system such as Enterprise Resource
Planning systems (ERP) or Manufacturing Resource Planning Systems (MRP),
etc. What is more, the laboratory must work in such a way that it adds
value to the manufacturing process and is not seen as a bottleneck within
the manufacturing process.
Laboratory Management System Solutions
STARLIMS solutions for the pharmaceutical and life
sciences provide the features and functionality required to help
laboratory organizations involved in this area maximize their contribution
to the business. In addition to the standard functionality and modules
that support this industry, STARLIMS is also a fully web-based system that
allows for simplified global deployment of the solution. LIMS is a vital
component in helping both the R&D and manufacturing sectors of the
pharmaceutical and life sciences industry meet their business and
regulatory goals.
Pharmaceutical companies use GAMP guidelines for their
validation of system such as LIMS. STARLIMS is concurrently designed with
these guidelines. It is defined as a ‘Closed System” under 21 CFR Part 11,
and classified as a Category 4 - Configurable Software Package.
STARLIMS addresses the needs of Pharmaceutical and Life
Science organizations by providing functionalities such as:
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Ability to
model Pharmaceutical and Life Sciences workflow requirements including a
comprehensive module for defining and managing Stability Studies
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Advanced sample management, location and tracking functionality to support
Medium and High Throughput screening including Plate Management
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Ability to store, manage and control all documents through the integrated
Document Management systemFull support for regulatory requirements
including full Audit Trail and 21 CFR Part 11
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Full Lot and Batch Management facilities
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Support for complex and multi step testing processes such as Dissolution
testing
Full traceability of all data and information generated within the system
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Definition and management of multiple country or regional product
specifications
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Support for required regulations and accreditation
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Ability to record and manage analyst certification
Full equipment management and maintenance functionality
Resource planning and scheduling functionality
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Flexible reporting functions that meet the complex requirements of a wide
variety of internal and external customers
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Integration of analytical instruments and clinical analyzers to speed up
data entry and reduce transcription errors
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Integration with other best of breed automation and enterprise systems
including ERP/MRP systems, including a certified link to SAP, achieved
through the use of a Web Services approach
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In addition, the inherent flexibility of the system
means that changes to business needs and working practices can be readily
supported and implemented without losing existing functionality or data.
STARLIMS is fully web-based and uses familiar user interfaces, which
simplifies both user training and implementation in new sites or new parts
of the organization. Global and multi-site deployment is also facilitated
thanks to web-based technology.
To Learn More about STARLIMS LIMS
Solutions, see also:
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