[ NuGENESIS LAB MANAGEMENT SYSTEM ]

THE LAB AND BUSINESS HAVE NEVER BEEN MORE CONNECTED

ENABLING RESULTS TO DRIVE BETTER BUSINESS DECISIONS

Waters® NuGenesis® Lab Management System uniquely combines synergistic data, workflow and

sample management capabilities to support the entire product lifecycle from discovery through

manufacturing. This user-centric platform encompasses NuGenesis SDMS, a compliance-ready

data repository, NuGenesis ELN, a flexible analytical electronic laboratory notebook, and

NuGenesis Sample Management.

NuGenesis seamlessly links data from

the lab to the business operations of the

enterprise with functionality such as sample

submission and results review, stability

testing, scientific search, multi-vendor

software connection, laboratory inventories,

data retention and legal hold, and

laboratory execution methods.

NuGenesis combines high impact

functionality with a high degree of

flexibility, readily adapting to your

organizations’ existing Informatics

environments – facilitate software

integration and standardization

without the complex, costly, and

time consuming deployments

often encountered with traditional

information management solutions.

With tens of thousands of licenses

sold around the world, NuGenesis is

enabling leading pharmaceutical,

chemical material, food and beverage,

and environmental companies

gain a deeper insight into scientific

challenges, accelerate decision-

making, and achieve better

business results.

[ NuGENESIS LAB MANAGEMENT SYSTEM ]

SAMPLE MANAGEMENT & STABILITY

TESTINGWORKFLOW

MANAGEMENT

SOFTWAREINTEGRATION

LABORATORYINVENTORIES

ELECTRONIC LABORATORY

NOTEBOOK

SCIENTIFIC DATA

MANAGEMENTSYSTEM

SCIENTIFIC SEARCH

REGULATORYCOMPLIANCE

SAMPLE MANAGEMENT

With NuGenesis Sample Management,

scientists can capture and manage

sample and result specifications,

assign samples to individuals or groups

for completion, and log in to determine

what analyses are required.

KEY FEATURES■■ Track, assign, and manage

samples, tests, and results

through their entire lifecycle

■■ NuGenesis SampleShare,™ an

optional web client, allows you

to electronically receive sample

submissions from and send PDF

reports back to labs that don’t

have NuGenesis

■■ Manage sample specifications

and product specifications with

country specific criteria

KEY BENEFITS■■ Shorten time from

sample submission

to result review

■■ Automate out of

specification result

identification

■■ Reduce transcription

errors

■■ Establish sample chain

of custody to meet

regulatory requirements

NuGenesis SampleShare dashboard for monitoring progress of current samples and reviewing completed sample requests.

STABILITY NuGenesis Stability allows you to

enforce a consistent, standardized

stability management

workflow and regimen across

all of your operations.

KEY FEATURES■■ Define study matrices including

time points, environmental

conditions, and test regimes

■■ Study review

■■ Sample pull overview across

all active studies that facilitates

the management of stability

groups workload

■■ Individual time point review

■■ Management and control

of the stability inventory

■■ Suite of stability reports

■■ Extensive statistical

results analysis

NuGenesis Stability facilitates the entire stability workflow, enhancing analytical effectiveness and delivering productivity improvements at every step of the process.

KEY BENEFITS■■ Flexible multi-dimensional

study design

■■ Ensure sample pulls are

performed on time

■■ Easily predict inventory

to complete your studies

■■ Compliant system reports

■■ Trace and view stability

results to the original

testing data

■■ Eliminate use of separate

statistical packages

■■ Proven statistical

reports for prediction

of product life

[ NuGENESIS LAB MANAGEMENT SYSTEM ]

NuGenesis SDMS

CENTRALIZED DATA REPOSITORY

The NuGenesis Scientific Data Management

System (SDMS) automatically captures and

catalogs diverse data generated by instruments,

scientists, and outside sources into

a centralized data repository.

CONTENT OF REPORTS

NuGENESIS SDMSELECTRONIC FILES

KEY FEATURES■■ Capture data from multiple

instrument techniques and vendors

■■ Fast search and retrieval with

automatic data capture and

indexing of results

■■ Extract and repurpose electronic data

into custom summary reports and

automated calculations

■■ Capture live, re-usable content

of reports in a compliance-ready,

secure environment

■■ Interfaces with LIMS, ERP,

and ELN solutions

■■ Tight integration with Waters’

Empower® and MassLynx®

Software solutions

■■ E-record lifecycle management from

data creation to retirement, including

data retention and legal hold

■■ Integration with Paradigm™

Scientific Search Software

KEY BENEFITS■■ Instant access to

scientific results

■■ Superior interpretation of

analytical information

■■ Supports regulatory

compliance efforts

and intellectual

property management

■■ Compliance-ready, secured

environment to manage

an organization’s entire

scientific data lifecycle

■■ Reduce time to process

data and generate reports

by up to 99%

■■ Reduce paper usage

by up to 90%

■■ Fast and accurate text

and science object-based

searches in all Waters’

Informatics software

(i.e., Empower, MassLynx)

ANALYTICAL DATA GENERATION

KEY FEATURES■■ Create predefined SOP templates

■■ Interfaces with balances, pH meters, CDS,

LIMS, and the NuGenesis SDMS repository

■■ Use for free flow (R&D) and prescribed

documentation (QC) workflows

■■ Track, assign, and manage samples,

tests, and results

■■ Integrated instrument and

consumable inventories

■■ Work with Microsoft® Excel and

other MS Office applications in a

compliance-ready environment

■■ A focal-point into laboratory databases;

orchestrates other software solutions

■■ Automate routine calculations

■■ Drag-and-drop PDFs or Microsoft

Office documents

■■ Certified to support the SAFE-BioPharma®

digital identity and signature standard

■■ Enables bidirectional communication with ERP

systems and is a certified interface to SAP-QM ®

■■ Empower interface for data review, sample set,

and result transfer

NuGenesis ELN

ANALYTICAL ELECTRONIC

LABORATORY NOTEBOOK

NuGenesis ELN is an analytical

electronic laboratory notebook that

allows laboratories to document

observations, control procedures,

exchange information with other

software solutions, and easily find

and collaborate on scientific results.

BALANCES

INVENTORY

NuGENESIS ELN

NuGENESIS SDMS

LIMS

SAMPLEMANAGEMENT

ANALYTICALCHEMIST

INSTRUMENTS

KEY BENEFITS■■ Transcription errors

reduced by nearly 100%

■■ Data review times

reduced by up to 75%

■■ More rapid final product

release and delivery

■■ Ensure analysts use

only valid/calibrated

instruments and

consumables

■■ Satisfy compliance

requirements

[ NuGENESIS LAB MANAGEMENT SYSTEM ]

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

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Australia 61 2 9933 1777

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Brazil 55 11 4134 3788

Canada 1 800 252 4752

China 86 21 6156 2666

Czech Republic 420 2 617 11384

Denmark 45 46 59 8080

Finland 358 9 5659 6288

France 33 1 30 48 72 00

Germany 49 6196 400 600

Hong Kong 852 2964 1800

Hungary 36 1 350 5086

India 91 080 49292200 03

Ireland 353 1 448 1500

Israel 9723 3731391

Italy 39 02 265 0983

Japan 81 3 3471 7191

Korea 82 2 6300 4800

Mexico 52 55 52 00 1860

The Netherlands 31 76 508 7200

Norway 47 6 384 6050

Poland 48 22 101 5900

Portugal 351 21 893 61 77

Puerto Rico 1 787 747 8445

Russia/CIS 7 495 727 4490 / 290 9737

Singapore 65 6593 7100

Spain 34 93 600 9300

Sweden 46 8 555 115 00

Switzerland 41 56 676 7000

Taiwan 886 2 2501 9928

UK 44 208 238 6100

US 1 800 252 4752

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

SALES OFFICES:

Austria 43 1 877 18 07

Australia 61 2 9933 1777

Belgium and Luxembourg 32 2 726 1000

Brazil 55 11 4134 3788

Canada 1 800 252 4752

China 86 21 6156 2666

Czech Republic 420 2 617 11384

Denmark 45 46 59 8080

Finland 358 9 5659 6288

France 33 1 30 48 72 00

Germany 49 6196 400 600

Hong Kong 852 2964 1800

Hungary 36 1 350 5086

India 91 080 49292200 03

Ireland 353 1 448 1500

Israel 9723 3731391

Italy 39 02 265 0983

Japan 81 3 3471 7191

Korea 82 2 6300 9200

Mexico 52 55 52 00 1860

The Netherlands 31 76 508 7200

Norway 47 6 384 6050

Poland 48 22 101 5900

Portugal 351 21 893 61 77

Puerto Rico 1 787 747 8445

Russia/CIS 7 495 727 4490 / 290 9737

Singapore 65 6593 7100

Spain 34 93 600 9300

Sweden 46 8 555 115 00

Switzerland 41 56 676 7000

Taiwan 886 2 2501 9928

UK 44 208 238 6100

US 1 800 252 4752

Waters, T he Science of What’s Possible, NuGenesis, MassLynx, and Empower are registered trademarks of Waters Corporation. Paradigm and NuGenesis SampleShare are trademarks of Waters Corporation. All other trademarks are the property of their respective owners.

SAFE-BioPharma is a registered trademark of the SAFE-BioPharma Association.

SAP-QM is a registered trademark of SAP.

NuGenesis SDMS is covered under a formal Quality Management System certified by Lloyd’s Register Quality Assurance. NuGenesis ELN is covered under a formal Quality Management System certified by the TÜv Rheinland Group.

©2014 Waters Corporation. Printed in the U.S.A.April 2014 720003597EN LM-SIG

www.waters.com/nugenesis