WATERS NuGENESIS LAB MANAGEMENT SYSTEM

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 provides a synergy of information management

technologies unlike anything available in the market today.

Capabilities such as sample management, workflow support,

integration of third party software and organizations, data

retention and legal hold, and stability testing allow NuGenesis

to connect the scientific data from your laboratories to the

business systems of your organization more effectively than

ever before.

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TABLE OF CONT ENT S

INTRODUCTION ..................................................................................................................................... 3

Platform Support ...................................................................................................................... 4

NuGENESIS SDMS – UPGRADES .......................................................................................................... 5

User Interface ......................................................................................................................... 5

Administrative Dashboard and Logging................................................................................. 5

Audit Trail ............................................................................................................................... 5

Data Retention ........................................................................................................................ 5

Paradigm Scientific Search .................................................................................................... 5

Language Support .................................................................................................................. 5

Example Projects .................................................................................................................... 5

Application Specific Data Adapters ....................................................................................... 5

NuGENESIS ELN – UPGRADES ............................................................................................................ 6

Empower/SDMS Interface ....................................................................................................... 6

Reporting Framework ............................................................................................................. 6

Template Management ........................................................................................................... 6

Menu Items for Custom Form Calls ......................................................................................... 6

Training Records ..................................................................................................................... 6

User Interface ......................................................................................................................... 6

NuGENESIS SAMPLE MANAGEMENT – NEW ....................................................................................... 6

NuGenesis Connectors ............................................................................................................ 6

NuGenesis SampleShare ........................................................................................................ 6

NuGenesis Stability ................................................................................................................ 6

Specification Management ..................................................................................................... 6

User Interface ......................................................................................................................... 6

Notice

The information in this document is subject to change without notice and should not be construed as a commitment by Waters Corporation.

Waters Corporation assumes no responsibility for any errors that may appear in this document. This document is believed to be complete

and accurate at the time of publication. In no event shall Waters Corporation be liable for incidental or consequential damages in connection

with, or arising from, the use of this document.

For updated information, please refer to the Release Notes.

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INT RODUCT ION

NuGenesis Lab Management System is the next significant milestone in the history of the

NuGenesis platform.

With further enhanced Data Retention Management and Legal Hold capabilities, integration of Waters

Paradigm Scientific Search, and an all new administrative dashboard, NuGenesis SDMS does not only

cover the entire scientific data lifecycle from beginning to end in a compliant, secure environment,

but also takes finding data and managing systems to a whole new level. NuGenesis ELN covers all

your lab execution, testing workflow, and integration needs with comprehensive features for tracking,

assigning, and managing samples, tests, and results; an easy to use web interface for submitting

samples; secure integration of data from external labs; and industry-leading stability testing support.

Together with a growing family of interfaces with popular lab IT systems, the lab and busy have never

been more connected.

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NuGenesis Component(s) Validated Operating Systems, Browsers, and Databases

Web application servers Windows 2008 Server R2 SP1 64 bit with IIS 7.5JBoss 5 (for ELN, included)Tomcat 6.0.29 (for SDMS, included)Java™ Runtime Environment Standard Edition 1.6/1.7 U 2 (included)

VISION web client, including Preview (print data viewer), and InSpector data viewer, Help Desk web client, Audit Trail viewer

Windows 8.1 Professional or Enterprise 64 bit (Internet Explorer 11 in Compatibility Mode) Windows 2008 Server R2 SP1 64 bit (Internet Explorer 8)Windows 7 Professional or Enterprise SP1 32 bit (Internet Explorer 8 + Internet Explorer 9 in Compatibility Mode)Windows 7 Professional or Enterprise SP1 64 bit (Internet Explorer 8 + Internet Explorer 9 in Compatibility Mode + Internet Explorer 10 in Compatibility Mode + Internet Explorer 11 in Compatibility Mode)Windows XP Professional SP3 32 bit (Internet Explorer 8)

Restore (file data restoration) Windows 2008 Server R2 SP1 64 bitWindows 7 Professional or Enterprise SP1 32 bit, 64 bit Windows XP Professional SP3 32 bit

NuGenesis ELN client Windows 8.1 Professional or Enterprise 64 bitWindows 7 Professional or Enterprise SP1 32 bit, 64 bit.NET 4.5 is required

UNIFY print capture modules, UNIFYps, SDMS administrator

Windows 8.1 Professional or Enterprise 64 bit Windows 2008 Server R2 SP1 64 bitWindows 7 Professional or Enterprise SP1 32 bit, 64 bit Windows Server 2003 R2 SP2 32 bit (Standard Edition; UNIFY only) Windows XP Professional SP3 32 bit

File capture modules, SCC Windows 2008 Server R2 SP1 64 bit, Windows 7 Professional or Enterprise SP1 64 bit Windows XP Professional SP3 32 bit

Oracle server Oracle 11.2.0.4 Server on Windows 2008 Server R2 SP1 64 bit,Sun Solaris UNIX Version 10, IBM AIX 6.1Red Hat Enterprise Linux AP 5.6 (64 bit) on x86-64Red Hat Enterprise Linux AP 6.2 (64 bit) on x86-64

Oracle client Oracle 11.2.0.4 Client on Windows 2008 Server R2 SP1 64 bitWindows 8.1 Professional or Enterprise 64 bitWindows 7 Professional or Enterprise SP1 32 bit, 64 bitWindows Server 2003 R2 SP2 (for use with Administrator only)Windows XP Professional SP3 32 bit

User identity servers supported for authentication

Microsoft Active Directory (Mixed Mode) on Windows 2008 Server R2 SP1 64 bit

Data source operating systems for file data

Windows 8.1 Professional or Enterprise 64 bitWindows 2008 Server R2 SP1 64 bitWindows 7 Professional or Enterprise SP1 32 bit, 64 bitWindows XP Professional SP3 32 bitPlease note that even though the file capture modules support all of the operating system entries above, data adapters that require a client application are restricted to those operating systems supported by that application as noted in section 5.c - Application-specific data adapters.

Data source operating systems for print data through the UNIFY print capture modules

Windows 8.1 Professional or Enterprise 64 bit Windows 2008 Server R2 SP1 64 bitWindows 7 Professional or Enterprise SP1 32 bit, 64 bit Windows XP Professional SP3 32 bit

Supported OS languages English, Japanese, Korean, Russian, Simplified Chinese For more details, please contact Waters Technical Support.

Platform Support

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User Interface

The VISION user interface has been redesigned for a more modern

look and feel as well as improved ease of use.

Administrative Dashboard and Logging

The NuGenesis Lab Management System brings extended logging

of events and metrics on the backend components (servers,

archive agent, data management, off-line storage management,

and transport engine). This rich information can now be processed

in the dashboard option (powered by SolarWinds) for near-real-

time insight into the system’s health.

Audit Trail

Easily find audit trail information on one or more records from

the VISION user interface.

Data Retention

Enhanced support for data retention policies and legal hold with

automatic application of legal holds and reports on configuration

and record status; SDK support.

Paradigm Scientific Search

Paradigm Scientific Search, an alternative searching mechanism

with unparalleled added capabilities, is integrated in the

Nugenesis Software.

Language Support

Supports English, Japanese, Korean, Russian, and Simplified

Chinese language environments.

NuGENESIS SDMS – UPGRADES

Application-Specific Data Adapters

Vendor Product / Version Data Element

Type

File

Pattern

Proxy

Enabled

JCAMP-DX

Conversion

Application

Client Required

Product

Technique

ABI-Sciex Analyst 1.2-1.6 File-based *.wiff, (*.wiff.scan), *.rdb

No No Yes LC/MS

Example Projects

NuGenesis comes with several example projects for use with:

■■ Waters Empower® Software■■ Archived Empower projects■■ Empower reports■■ AQT reports■■ SystemsQT™ reports

■■ Waters MassLynx® Software ■■ AB Sciex Analyst■■ Agilent ChemStation■■ Thermo Scientific Xcalibur

■■ Bruker BioSpin HyStar/Compass

These projects are also included on the NuGenesis installation

media and feature:

■■ File Capture templates for use with Empower and standard

mass spectrometry software

■■ Print Capture templates for default reports

■■ Predefined NuGenesis SDMS projects with tag values and views

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NuGENESIS SAMPLE MANAGMENT – NEW

The Sample Management functionality of the NuGenesis ELN

allows for more flexibility concerning the usage and visualization

of information (fields) on request, test and sample level.

NuGenesis Connectors

NuGenesis Connectors are configurable utilities that provide

a direct link between the NuGenesis Lab Management System

and business systems such as SAP. This link facilitates seamless

communication of instructions and information including

test requests, standard operating procedures (SOPs), product

specifications, and test results.

NuGenesis SampleShare

A web-based sample submission client enables users to securely

register samples in NuGenesis from any browser. This allows

a seamless transfer of sample data to and from any external

laboratory, business unit, or customer.

NuGenesis Stability

NuGenesis Stability is a complete stability protocol management

and testing solution integrated into the NuGenesis Laboratory

Management System. Developed in accordance with the current

GAMP and ICH guidelines, it is a fully validated and tested

software application that uses industry-recognized calculations.

Specification Management

The specification management module has been enhanced

to support the definition of product specifications including

products, tests, references to analytical procedures (methods) and

acceptance criteria on result level. Additionally it is possible to

define limits for multiple countries within one specification.

User Interface Updates

To improve the sample management user experience, various

improvements have been made for a better visual indication of

status information and exceptions that have occurred based on

entered results that are off-limit.

NuGENESIS ELN – UPGRADES

Empower/SDMS Interface

The Empower and SDMS interface of the NuGenesis ELN includes

new functionality and ergonomic enhancements. The functionality

reduces the number of mouse clicks required to transfer Sample

Set and Results Data to and from Empower and SDMS. This tool

helps you more easily leverage the data and information collected

in these two systems and repurpose it within your technical

worksheets and documentation. All while reducing transcription

errors and increasing the rate at which information is being

gathered and processed and strengthening your compliance with

regulations like 21 CFR Part 11 and Annex 11.

Reporting Framework

The enhanced reporting framework supports the definition of

report templates with configurable input parameters that a user

can enter at runtime to get the information they are looking for.

The reports can be exported into various formats (e.g., HTML,

CSV, TEXT, and EXCEL). Based on the new reporting framework

there is a variety of standardized out-of-the-box reports that

provide metrics and lab statistics information to the user.

Template Management

To reduce the number of overall templates and minimize

the validation efforts, it is now possible to manage a list of

parameters and multiple sets of values for the parameters that are

stored with the template definition. When a document is generated

based on a parameterized template, a set of parameter values is

used to initialize the document parameters.

Menu Items for Custom Form Calls

It is now possible to integrate menu items to call custom forms

and third party plug-ins. The plug-ins can be integrated into the

UI as menu entries/shortcuts or as additional actions in the

My Work pages or Document Editor.

Training Records

There is a new dedicated screen to track the training records for

users that control the access to a template.

User Interface Updates

To improve the sample management user experience, various

improvements have been made for a better visual indication of

status information and exceptions that have occurred based on

entered results that are off-limit.

Waters Corporation 34 Maple Street Milford, MA 01757 U.S.A. T: 1 508 478 2000 F: 1 508 872 1990 www.waters.com

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

©2014 Waters Corporation. Produced in the U.S.A.July 2014 720002315EN LM-PDF