[N GENESIS SDMS] SDMS - Waters Corporation · 2014-04-29 · NuGenesis SDMS is an...
Transcript of [N GENESIS SDMS] SDMS - Waters Corporation · 2014-04-29 · NuGenesis SDMS is an...
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SDMS[ NUGENESIS SDMS ]
THERE’S NO LIMIT TO WHERE DATA CAN TAKE YOU
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CONVERTING SCIENTIFIC RESULTS INTO
BUSINESS SUCCESS
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[ NUGENESIS SDMS ]
USEto send selected data to
NuGenesis ELN and other software:MS Office, LIMS, ERP
FIND/VIEWcritical datain seconds
CATALOGaccording to yourprotocols/projects
MANAGEentire datalifecycle
CAPTUREall of your data from
instruments and scientists
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Waters® NuGenesis® Scientific Data Management System (SDMS), the automated data repository of the NuGenesis Lab Management System, has a proven track record of optimizing the management of scientific data for hundreds of companies around the world.
With NuGenesis SDMS, laboratories are able to automatically capture, secure, access, and disseminate information from a wide variety of analytical technologies.
The instant accessibility of this information has resulted in stronger collaboration, more efficient operations, better decision making, and ultimately, accelerated product development and delivery for these world-class organizations.
The ability to collect, process, and distribute
scientific information is fundamental to the
long-term success of science-driven organizations.
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UNITE YOUR LABORATORIES, RESEARCHERS, AND INSTRUMENTSThe amount of experimental data generated
by analytical laboratories is increasing
exponentially, given the technology
advances in instruments, column
chemistries, and hyphenated techniques.
Streamline how you capture and organize
your critical scientific data across its entire
lifecycle – so that it can be accessed,
intelligently aggregated, and stored for
the long term by workers in any laboratory
within your organization. Ensure adherence
to GxP-driven retention and retirement rules
through flexible data retention management
capabilities, including legal hold.
NuGenesis SDMS provides laboratories
with an effective foundation for scientific
information management by making data
easier to access, facilitating compliance
with regulatory requirements, and aiding in
the administration of intellectual property
throughout its lifecycle, from capture
to retirement.
It automatically imports diverse data
generated by instruments, scientists, and
outside sources into a centralized data
repository. This information can easily
be searched, communicated, and shared
among scientists and team members
collaboratively – delivering measurable
gains in time to market and employee
efficiency while reducing cost and risk.
An updated web-based interface makes
NuGenesis SDMS easier than ever to use and
integration with Paradigm™ Scientific Search
Software will improve scientific information
accessibility for your organization.
Add the NuGenesis Electronic Laboratory
Notebook (ELN) to provide you with
powerful means to access and publish
data as well as capabilities for laboratory
execution methods. It greatly enhances
your information management workflow,
allowing your teams to work more
intuitively and productively.
NuGenesis SDMS is a complete and
configurable solution for IT, laboratory,
regulatory, and business management
personnel. It is a powerful tool that converts
raw scientific results into valuable and
accessible corporate knowledge.
By integrating all scientific results,
NuGenesis SDMS is the foundation of
the NuGenesis Lab Management System –
enabling integration for the entire
laboratory IT landscape – from instrument
control software up to LIMS and ERP.
SDMS interoperability reduces IT complexity and expense
Many laboratories have a number of
different software packages, each designed
to serve specific lab purposes. These
software packages include LIMS and
electronic document management systems,
enterprise resource management systems,
departmental-level data systems for
specific instruments, and various desktop
products. These systems are typically
highly customized, and require significant
investments to ensure interoperability and
ongoing maintenance and support.
Vital to managing this “patchwork quilt”
of software is the interconnectivity of
data elements to allow further processing.
The NuGenesis Lab Management System
provides a base-layer infrastructure that
directly connects your raw data to your other
enterprise systems and software programs.
This eliminates the need for complex and
expensive point-to-point integration with
each data source.
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NuGenesis SDMS provides a single
interface to all of your instrument software
and data exporting sources. It can work
independently or in conjunction with
existing IT systems such as LIMS, ERP, ELNs,
specialized analytics applications, and
visualization programs. Fully configurable,
NuGenesis SDMS scales from a single
laboratory to a global enterprise without
any major modifications to your existing IT
infrastructure. NuGenesis SDMS uses the
Oracle® 11g database, which provides higher
performance, as well as added enterprise
management, backup, and recovery tools.
NuGenesis Connectors
NuGenesis Connectors are configurable
utilities that provide a bidirectional link
between the NuGenesis Lab Management
System and business system applications
such as SAP. This link facilitates seamless
communication of instructions and
information including test requests,
standard operating procedures (SOPs),
product specifications and test results.
By enabling the NuGenesis Lab Management
System to more readily bridge the
documentation and workflow gap between
the laboratory and business, NuGenesis
Connectors facilitate timely access to
sample results – supporting a more accurate
and rapid decision-making process.
Seamless integration with existing IT systems
BUSINESS SYSTEM APPLICATIONS NuGENESIS LAB MANAGEMENT SYSTEM
NuGENESIS CONNECTORSSAP, LIMS,
Workflow Manager, etc.Analytical Report,
COAComplex
Data SourcesSample
Result RouterSimple
Data Sources
NuGenesis Connectors provide a direct link between the NuGenesis Lab Management System and Multi-Vendor Business System Applications.
KEY BENEFITS OF NuGENESIS CONNECTORS INCLUDE:
■■ Reduction of paper processes
and manual transcription
■■ Comprehensive documentation
and data traceability
■■ Easier data sharing and collaboration
■■ Minimize waste and variability
during quality testing
■■ Ability to generate standard and
customized analytical reports
■■ Helps your scientists focus on science
■■ Faster release of in-spec products
[ NUGENESIS SDMS ]
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Build a data management foundation
NuGenesis SDMS helps you maintain data
throughout the entire information lifecycle
by integrating these attributes into a single
electronic information solution:
■■ Vendor-neutral data capture,
management, and re-utilization
■■ Consistent and secure
application environment
■■ Data administration and governance
that supports intellectual property
protection and compliance
■■ Long-term data retention,
retirement, and legal hold
NuGenesis SDMS is an application-
independent software and database
platform that you can use to create
a common electronic repository for
scientific information throughout your
company – from the raw data generated
by instruments to project documents and
electronic laboratory notebook reports,
spreadsheets, summary documents, and
presentations created by researchers.
This comprehensive software solution is
designed to integrate the collaborative
flow of information throughout a global
scientific organization. Analysts will
have more time to focus on analysis and
interpretation, enabling your organization
to make better decisions.
NuGenesis SDMS Technology allows
scientific data generated from the vast
array of data sources in your laboratory
to be accurately and automatically saved
immediately after its creation or change.
Print and file data can be captured,
indexed, securely stored, and made
available to authorized users according
to the appropriate data archival policies
for the organization and IT infrastructure.
What’s more, proprietary analytical data
formats can be automatically converted to
technology-neutral standard formats.
With NuGenesis SDMS, you can manage:
■■ Print data, which includes the actual
content of instrument generated reports
(not just a static image), such as
LC, GC, LC/MS, NMR, IR, and UV-VIS
data reports, as well as result reports
■■ Raw instrument data, such as spectra
and chromatograms
■■ Spreadsheets, presentations, and other
document files and printed reports from
scientific and business applications
■■ Content generated by a variety of
operating systems, including
Microsoft® Windows and UNIX
■■ Vendor-neutral and internationally
standardized data-exchange formats,
including IUPAC JCAMP-DX
Capture and archive data for long-term storage
NuGenesis SDMS offers a fresh new user interface with a wide array of flexible search capabilities.
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Find and retrieve data
First, NuGenesis SDMS scouts all of your
servers, projects, and data types for any
new content. Then it automatically extracts
metadata (data about data) during the
capture process. During this process, a
database catalog is built, which gives you
the ability to quickly and easily perform
searches across your servers, projects,
and data types.
Complex data mining becomes much
easier – search, retrieve, and view
information according to a variety of data
types, and restore your results to their
original applications. Then you can reuse
that information as necessary, whether for
manual review or calculations. Or you can
automate this process using other tools
and templates you can configure within
the software.
NuGenesis SDMS’s sophisticated search
filters and retrieval tools enable you to:
■■ Find any text included in printed
reports, graphs, tables, or charts
■■ Simultaneously view multiple reports
from disparate sources
■■ Instantly view analytical data in a
number of formats – without the
source applications
■■ Easily restore instrument data
for further analysis
NuGenesis SDMS also seamlessly
integrates with Waters Paradigm
Scientific Search Software. Launch
Paradigm right from SDMS to access
powerful new search capabilities in a
simple, modern user interface:
■■ Text/key word search■■ Search by document■■ Search by digital image■■ Chemical structure/reaction search■■ Search by analytical dataset■■ Biological content search
Paradigm Scientific Search breaks down the barriers to information accessibility by providing an easy-to-use interface along with fast and accurate text and science object-based searches. Users spend less time searching for information and more time using information to make better, evidence-based decisions.
Mine information in NuGenesis SDMS or upgrade to full Paradigm Scientific Search Software to enable fast, easy, high-value searches across multiple enterprise data sources.
[ NUGENESIS SDMS ]
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When following the typical path of
analytical data in the laboratory, many
scientists still work with printed reports
that are generated by otherwise highly
automated instruments and analytical
software packages.
In most cases, these printed reports and
documents are used to define success or
failure, and determine future experiments
within the laboratory.
The patented NuGenesis SDMS Print Capture
driver installed on a networked data source
workstation or PC, allows the systems to
capture the actual content of a report (not
just a static image). It saves your data in an
Oracle relational database, which stores all
pertinent metadata for subsequent searches.
Print capture: a universal format for viewing and extracting data
The NuGenesis SDMS electronic signature tool allows users to follow a compliant review process.
NuGenesis SDMS provides you with the tools to transform your data into highly accessible and reusable information, improving workflows, collaboration, and compliance.
All of your report contents are text-
searchable and vector-scalable. Now your
data can be mined and parsed into other
software applications, such as statistical
and visualization programs; Microsoft
Office (Excel, Word, PowerPoint); a LIMS
application environment; or a specific
laboratory data management tool,
such as NuGenesis ELN.
With automated parsing, transfer of
information from multiple source
reports into another application can
be accomplished in seconds without
transcription errors.
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With NuGenesis SDMS, researchers can quickly assemble and collaborate on documents that preserve a direct connection to the supporting data through hyperlinks.
Use valuable data – over and over again
The benefits of being able to repurpose data
are clear to any organization. NuGenesis
SDMS provides you with the tools to
transform your data into highly accessible
and reusable information, improving
workflow, collaboration, and compliance.
Using Preview, the software’s Print Data
Viewer, you can streamline the process of
finding and inserting data into electronic
documents. Create high-fidelity custom
reports from data or pieces of reports,
which can be inserted and re-sized as
necessary, while hyperlinks provide
source-data traceability.
With just a click of the mouse from a
newly-assembled report, you can retrieve
the original data; and depending on
security levels, you can review, restore, or
reprocess that information on the original
instrument acquisition software.
What NuGenesis SDMS essentially provides
is the ability to “copy and paste” the
highest quality vector-scalable graphics,
text, or table data directly into other
programs while maintaining continuous
references to the source data with
embedded, traceable hyperlinks.
Researchers thus gain the ability to mine
data and with that information, they can
communicate and report on that data
more easily.
The same automated parsing technology
that our customers have come to rely on
for print data can now be applied to PDF
files, making content available for easy
integration with other lab IT systems with
minimal human intervention.
Work compliantly with electronic signatures, sequencing, and annotations
The NuGenesis Lab Management System
addresses 21 CFR Part 11 and intellectual
property protection requirements
for electronic records, including
electronic signatures.
In addition, NuGenesis SDMS’s electronic
signature sequencing capability
automatically notifies others who are
waiting to view, approve or edit the data
being originally signed – providing
a compliant review process. With this
functionality, organizations can improve
collaboration among team members
and management. Each contributor is
able to provide technical insights and
observations while adding and associating
that knowledge directly with the raw data
entry. This simultaneously encourages
collaboration while capturing intellectual
property for each data element of any given
project or program in a controlled, recorded,
and accessible application environment.
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The InSpector Data Viewer provides full-fidelity display and review capabilities for analytical files, including metadata information.
Vendor-independent analytical data viewer
NuGenesis SDMS expands information
review capabilities by including Waters’
InSpector Software. This vendor-independent
data viewer provides additional report
review capabilities by enabling you to
review data using the real data points.
InSpector Software makes it easy to
visualize and share analytical information
clearly and consistently. It allows you to
view data from a variety of commonly used
techniques, including optical spectroscopy,
NMR, MS, chromatography, hyphenated
methods, and chemical structures – right
on your computer desktop, without having
a specific spectroscopy or chromatography
data system installed.
InSpector Software supports long-term
stable JCAMP-DX and -CS file formats,
MOL files, as well as several third-party
data formats. It simplifies the process of
exchanging information with coworkers,
especially for scientists needing a deeper
view into analytical data.
These advanced visualization tools
highlight key analytical features:
■■ View all kinds of analytical data,
from single spectra to 3D data
(not just images)
■■ Supported techniques include NMR,
MS, LC/MS, IR, UV/Vis, fluorescence,
chromatography and hyphenated
experiments, and chemical structures
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Customized integration with the Software Development Kit
NuGenesis SDMS features enhanced
integration with other Waters Laboratory
Informatics solutions, such as Empower®
and MassLynx® Software. Waters also offers
Software Development Kits that provide
additional tools you can use to create
custom workflows or data mining programs
that automate the process of extracting or
exchanging data between NuGenesis SDMS
and other systems and software.
These Software Development Kit programs
can, for example, extract specified
data from NuGenesis SDMS to populate
spreadsheets, databases, electronic
laboratory notebooks, and other analysis
tools, so that complex processing and
analyses can be performed. Operations in
NuGenesis SDMS can be scripted to trigger
activities in other applications, thereby
facilitating workflow processes
and improving data exchange.
Validation, Service, and Support
The long-term success of your use of
NuGenesis SDMS depends on how well you
plan, deploy, and maintain your systems
and the degree to which you keep your
users’ knowledge and training up to date.
The Waters’ Informatics Professional
Services team provides the programs
and services you need to maintain
the level of performance you expect
from your Waters’ products. Waters
offers a variety of solutions for Service
and Support, Training and Education,
and Regulatory Compliance.
Waters’ Informatics Professional
Services can develop and execute
the necessary qualification protocols,
as well as deliverables that define the
validation process for your NuGenesis
SDMS installation.
Our test documents are developed to
challenge critical regulatory requirements
as required for GMP (21 CFR Part 210, 211,
820), GLP (21 CFR Part 58), EU GMPs,
Annexes 11 and 15, EU Parliament –
E-Signatures (EU Directive 1999/93/EC),
ICH Q7A, and 21 CFR Part 11 guidelines,
as well as industry expectations.
Validation solutions include:
■■ Clearly defined project scoping,
including resources and deliverables
■■ Prepackaged Installation and
Operational Qualification
(IOQ) protocols
■■ Customized protocols based
on user requirements
■■ Validation plan design and deliverables
around the validation process in
accordance with GAMP and PIC/S
■■ Certified validation engineers
■■ Highly reduced timelines
to production use
NuGenesis SDMS provides single-platform enterprise technology that seamlessly integrates lab and business IT systems.
[ NUGENESIS SDMS ]
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Waters, T he Science of What’s Possible, NuGenesis, Empower, and MassLynx are registered trademarks of Waters Corporation. Paradigm is a trademark of Waters Corporation. All other trademarks are the property of their respective owners.
©2014 Waters Corporation. Printed in the U.S.A. April 2014 720000842EN LM-SIG
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