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©2014 Waters Corporation 1 NuGenesis Lab Management System

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©2014 Waters Corporation 1

NuGenesis Lab Management System

©2014 Waters Corporation 2

The Changing Face of Industry

What we were hearing from customers:- – ‘The analysis is essential, but being able to manage the data is the

problem’

– ‘How to rationalize and centralize their business information systems?’

– ‘I need workflow and sample management capabilities but I don’t

require a full featured LIMS’ – ‘Manage tests and follow protocols with flexibility of working in both

structured and unstructured workflows’

©2014 Waters Corporation 3

Challenges in the Industry

Revenue at Stake • Patent Cliff • Competitive Solutions • Product Pipeline

Cost Control • Streamline

Development • Globalize Operations • Simplify Processes

Optimize Use of Assets • Standardisation • Flexible Use of

Employees • Outsourcing

©2014 Waters Corporation 4

Challenges at Lab and IT level

Simplify Lab Processes •Remove Non-Value Added

Steps •Right First Time •Flexible and Manageable

Standardization •Global Applications •Compliance •Easy Integration

©2014 Waters Corporation 5

Current Solutions

DISCOVERY DEVELOPMENT QC

ERP

LIMS B

LES

SDMS

CDS

Instrument

LIMS A

ELN B

SDMS

CDS

Instrument

SDMS

MS Software

Instrument

ELN A

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Current solutions driving Business Systems into the lab often… Leave significant gaps Frustrate the users Are difficult to deploy

and support Don’t deliver the expected

Return on Investment

The Challenge

ERP

LIMS

ELN

SDMS

CDS

Instrument

Business Systems

Laboratory Systems

©2014 Waters Corporation 7

Solution with NuGenesis LMS

DISCOVERY DEVELOPMENT QC

Business Systems

Instrument Instrument Instrument

Business Systems

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©2014 Waters Corporation 9

What is NuGenesis Lab Management System? NuGenesis LMS Data Management (SDMS)

o Bring together all the information from all instruments and analytical

techniques in a single database o Provide the tools to manage, repurpose, archive, protect and ensure

compliance in a single location

NuGenesis LMS Laboratory Notebook (ELN)

o Provide the tools to document experimental design and results, from free-form R&D environments to process-driven QA laboratories, in a single package

NuGenesis LMS Laboratory Management (LMS)

o Provide the tools to implement customised workflows, allowing data to

be taken from instruments and taken through the entire process to final disposal.

o Help eliminate the need for cumbersome, traditional mechanisms for workflow management

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NuGenesis Lab Management System

©2014 Waters Corporation 11

Capturing and Cataloging Scientific Data

Sampling Analytical Data Acquisition

Data Processing Results

File Data Printed Results

NuGenesis SDMS Long Term Archive

E-signature Project Auto

©2014 Waters Corporation 12

View Data Without Original Software

Gel Images

HPLC

Mass Spec NMR

©2014 Waters Corporation 13

View Data With InSpector

©2014 Waters Corporation 14

Data Management – Data Lifecycle

Data Retention can be Enabled on a Project

Flexible Retention Policies

Complete Manual or Automatic Deletion After Expiration

Legal Holds will Prevent Any Change or Deletion

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New Advanced Search

NuGenesis Lab Management System has a new search engine

Using Paradigm Scientific Search – Is a corporate scientific search – New and novel technology – Introduced 2013

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Integrated Paradigm™ Scientific Search

Search NuGenesis and Empower for the following:

Text/Key Words

Search-by-Document

Digital Image

Chemical Structure or Chemical Reaction

Analytical Dataset

Biological Content as Science Objects

©2014 Waters Corporation 17

NuGenesis Lab Management System

©2014 Waters Corporation 18

Major Types of Testing

Discovery, Investigative – Free-flow – Geared towards new

scientific discoveries – Seeks to protect

intellectual property rights

Process Driven, Investigative – Follows established methods – Geared towards repeat tasks – Often used to compare to

regulations e.g. DEFRA

Maze obtained from pbs.org

Test Test

?

©2014 Waters Corporation 19

NuGenesis 8 Freeflow Lab Notebook

Introduction Experimental

Results

Conclusions

©2014 Waters Corporation 20

Any Information Can Be Included

Text including tables, pictures etc. Images and drawings Chemical structures and reactions Analytical data such as spectra,

chromatograms, properties Biological data Reports Scans, movies ...

To a solution of dry methyl 1--D-ribofuranosyl-4,5-imidazoledicarbo xylate2 (2) (500 mg, 1.58 mmol) in dry pyridine (10 mL) was added 1,3-dichloro-1,1,3,3-

tetraisopropyldisiloxane7 (550 mg, 1.75 mmol), and the mixture was stirred for 4 h at ambient temperature with...

Analytical Data Yield 800 mg (91%) Rf 0.38 (chloroform/ methanol, 30:1)

O

O

O

NH3 NH

O

O

+

Acylation of Amines by Anhydrides: Amino-de-acyloxy-substitution

©2014 Waters Corporation 21

Combine Procedure and Data Entry Using Electronic Forms

Procedure

Data Entry

©2014 Waters Corporation 22

Simple Devices – Balance Integration

©2014 Waters Corporation 23

Test Preparation and Specifications – Test Documentation

Transferred from ERP Scanned Bar Codes

©2014 Waters Corporation 24

NuGenesis 8 - Workflow Management Defined Workflow & Easy Review

©2014 Waters Corporation 25

Integrated Supporting Inventory

Supporting Document

Instrument Standards Reagents

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Inventories

©2014 Waters Corporation 27

NuGenesis Lab Management System

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“My Work Portal” User Centric Access

Needs overview about the status of the work Assign tests to analysts Needs overview entire request context Review test documents Approve test requests

Find all pending tests that relevant for them Calibrate instruments Run and document the actual tests Check in/out samples Print sample labels

Lab Manager

Analyst

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NuGenesis 8 Sample Management (Requests)

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NuGenesis 8 Sample Management (Tests)

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NuGenesis 8 Sample Management (Samples)

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Review-By-Exception

Result correct?

Result not modified?

OOS?

Who is responsible?

Result signed?

Reagents fit-for-use?

Instruments fit-for-use?

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NuGenesis 8 available interfaces NuGenesis 8 SAP-QM interface Providing a bi-directional SAP certified interface to minimize transcription errors through automation of information transfer from SAP-QM NuGenesis 8 SDMS interface to ELN Support of external third party laboratories data and direct access to file and printed information within NuGenesis ELN and Sample Management Support of simple devices Direct interface to small laboratory devices such as balances and pH meters and LabX software NuGenesis 8 interface to Empower Create sample sets, access, review and process data within Empower data within NuGenesis

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NuGenesis Lab Management System

What’s New:

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Stability Workflow

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NuGenesis Lab Management System

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Integration with External Labs: Web Interface

Add samples one by one or import a list

Review status of all samples Quickly check for Notifications

Account settings

Top level view of the Dashboard

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NuGenesis Lab Management System

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Connecting the Laboratory to Business

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NuGenesis Lab Management System

LIMS Capabilities without the Complexities

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