SDMS[ NUGENESIS SDMS ]

THERE’S NO LIMIT TO WHERE DATA CAN TAKE YOU

CONVERTING SCIENTIFIC RESULTS INTO

BUSINESS SUCCESS

[ NUGENESIS SDMS ]

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FIND/VIEWcritical datain seconds

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MANAGEentire datalifecycle

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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.

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.

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 ]

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.

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 ]

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.

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.

[ NUGENESIS SDMS ]

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

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

Waters Corporation 34 Maple Street Milford, MA 01757 U.S.A. T: 508 478 2000 F: 508 872 1990 www.waters.com

www.waters.com/nugenesis