Innovations in Laboratory Data Management A Guide to ... › webassets › cms › events › docs...Innovations in Laboratory Data Management A Guide to Waters Informatics Future

2011 IETF Day 2 Tisdale 1

Innovations in Laboratory Data ManagementA Guide to Waters Informatics Future

© 2011 Waters Corporation | COMPANY CONFIDENTIAL 1©2010 Waters Corporation | COMPANY CONFIDENTIAL

Vern Tisdale

Director, Informatics Product Management

The Product Portfolio

MassLynxMass Spectrometry Software

EmpowerChromatography Software

NuGenesisSDMS, ELN, and LES Software

© 2011 Waters Corporation | COMPANY CONFIDENTIAL 2

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Portfolio Integration


What is UNIFI?

Single Platform for Chromatography, Mass Spectrometry, Data Management and Laboratory WorkflowData Management and Laboratory Workflow

Intuitive User Interface

Solution for Regulated or Non-Regulated Laboratory

Scalable Open Architecture


Scalable Open Architecture

Complete Application Solutions


Intuitive user interface adjusts to roles and capabilities of users


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Role


ReviewReview Quality Metrics inQuality Metrics inRegulatory or SOP DocumentsRegulatory or SOP Documents

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Industry leading security, compliance configurations; built in change control tools



System Solutions

CoreCompetencies

ProteomicsSystemSolution

SystemSolution

Chemistry

SeparationsScience

Application System Solutions

BiopharmaceuticalSystemSolution

ApplicationExpertise

ScreeningSystemSolution

LipidomicsSystem

Solution Solution

SystemSolution


Software

MassSpectrometry Regulated

BioanalysisSystemSolution

SystemSolution

Food SafetySystemSolutionSystem

Solution

SystemSolution

Biopharmaceutical System Solutionwith UNIFI

What is it?— An analytical platform for UPLC/UV and

UPLC/MS biotherapeutic analysis / p ydeployable across unregulated and GxP laboratories

System Description:— ACQUITY UPLC H-Class and H-Class BI— XEVO G2 Tof, TUV Optical Detector— BioSeparations Chemistries — UNIFI Scientific Information System

Applications:


Applications:— Intact protein analysis— Peptide mapping

Launched WCBP January 2011


Regulated Bioanalysis System Solutionwith UNIFI

What is it?— Next version of UNIFI to support our System

Solution for the Regulated Bio analysis market Solution for the Regulated Bio analysis market space

— Intuitive, streamline and secure workflows tailored specifically for the bioanalyst

Applications:— Regulated Bioanalysis


System Description:— ACQUITY UPLC, ACQUITY I-Class

— Xevo TQ-S and Xevo TQ Tandem Quadrupoles

— UNIFI Workgroup

Launched ASMS 2011

N-tier architecture

ReportingData Processing

Event CenterRegulatory Compliance

Document ApprovalSecurity

Audit Trails

Waters LCWaters MSMulti-Vendor LCMulti-Vendor GCOther Technologies

PORTAL CLIENT


DATABASE

APPLICATION LAYER ACQUISITION CONTROL

User AccountsContentAudit TrailsSystem Configuration


DeploymentWorkstation Scenario

Presentation LayerBusiness LayerDatabase Layer


Workstation Installation Instrument System

Instrument Control

DeploymentWorkgroup (Small Enterprise) Scenario

Presentation Layer

Presentation Layer

Client PC Client PC

InstrumentControl

Laboratory Network Device

Presentation LayerCapture Agent

Client PC

<< LABORATORY NETWORK >>

y y Capture Agent



InstrumentControl

Server

Business LayerDatabase Layer



Benefits— UNIFI Device Management enhancements

— Provides enhanced raw data security

— Remote access to instruments

— Data buffering

— Enhanced performance for instrument systems

— Hardware and Software Embedded Image preconfigured and tested by Waters

o End user does not need to understand the


o End-user does not need to understand the details of the operating system

o Designed to be very easy to operate and provide narrow selection of network services

o Leverages Microsoft Windows Embedded OS

InstrumentControl

Presentation Layer

Presentation Layer

DeploymentEnterprise Scenario

Client PC Client PCLaboratory Network

Device

ControlLayer Layer

<< CORPORATE NETWORK >>


InstrumentControl

Database ClusterApplication Cluster

Business Layer Database Layer



UNIFI Scientific Information System

Best of breed functionality of the entire Waters Informatics portfolio— CDS, MS, SDMS, ELN and LES, , ,

Provides for migration of NuGenesis content as well as Empower and MassLynx data and methods

Increased support for legacy and third party instruments


Deployable on a global enterprise scale

Workstation Workgroup Enterprise

General Time Line for Informatics

UNIFI Full Function Enterprise Version

2011UNIFI Workgroup

for Regulated Bioanalysis 2012

2006MassLynx 4.1

2007NuGenesisSDMS 7.1

2010Empower 3 2011

UNIFIWorkstation for BioPharm

2012NuGenesis 8

BioanalysisUNIFI Workgroup

other system solutions


Integrated ELN, CDS and SDMS

Designed for the Enterprise

Full Migration ofData and

Capabilities

Proof ofConcept

InitialScalability

SAP QM Integration,QC Application Package,

Sample Management

Multiple SolutionPlatform


Empower 3

Architecture

Web based licensing Web based licensing

ACQUITY improvements

Fraction Collection

Usability and Workflow

Mass Spectrometry

Method Validation Manager

D i d f h E i


Designed for the Enterprise

Post Empower 3 Projects

Service Feature Feature Service Release 1

•Released July 22, 2011• This release includes

addressing three critical defects including the data checks to identify channels which are impacted by the IEEE Data dropouts integrity issue during data acquisition.

•Released July 22, 2011• This release includes

addressing three critical defects including the data checks to identify channels which are impacted by the IEEE Data dropouts integrity issue during data acquisition.

Feature Release 1

•Target Release December 2011

• Oracle RAC • Oracle Data Guard • Web Services • Sun Solaris 10• 7890 Dual Tower support

•Target Release December 2011

• Oracle RAC • Oracle Data Guard • Web Services • Sun Solaris 10• 7890 Dual Tower support

Feature Release 2

•Target Release Dec 2012• Dissolution, 20 Bath Support

and USP Multi-Stage Protocol• Usability• Method Validation Manager• Relative acceptance criteria • Improvements to Stability,

Filter Validation, and Specificity T t t ll lid ti f

•Target Release Dec 2012• Dissolution, 20 Bath Support

and USP Multi-Stage Protocol• Usability• Method Validation Manager• Relative acceptance criteria • Improvements to Stability,

Filter Validation, and Specificity T t t ll lid ti f


Tests to allow validation of impurity methods

• Content uniformity• System Policies based on

Project Hierarchy• Workflow enhancements • Ease of use enhancements

Tests to allow validation of impurity methods

• Content uniformity• System Policies based on

Project Hierarchy• Workflow enhancements • Ease of use enhancements


NuGenesis 8

Technology Enhancements— Oracle and Windows operating systems

Web based licensing Web-based licensing— Based on same technology deployed with

Empower 2 FR5 and 3

Record Retention and Legal Hold

Ease-of-use improvements— User Interface Enhancement to improve software

navigation


Sample Management

Specification Management

Migration to next generation software

Architecture

Technology:— Oracle 11G R2 Database Oracle 11G R2 Database

— Windows 2008 R2 Server (64 bit)

— Windows 7 Professional (64 bit)

— Tomcat 6.0.29

— Java Runtime Environment 1.6

— Secure FTP for Managed Storage

— Internet Explorer 8+9


Streamlined User Administration— Basic VP user setup in SDMS Admin

— Import and export user names, groups, and their privileges


User Interface Enhancements


NuGenesis - SAP QM interface

NuGenesis - SAP QM interface is a framework for integrating of the Waters NuGenesis with SAP R/3 QM-IDI

The SAP QM supports quality processes for all industries and can be used as a Enterprise LIMS — Includes Quality Planning, Inspection,

Certificates, Notification, Control, Audit Management, Equipment Management and


Management, Equipment Management and Stability Study

Bidirectional interface to eliminate manual information transfer and improve laboratory productivity


NuGenesis 8 Forms

What are NuGenesis Forms?— Predefined forms to execute common laboratory testPredefined forms to execute common laboratory test

o Completely validated workflow

o Can be deployed as-is or with little configurations

— Re-usable sectionso Facilitates creation of new workflows/templates

What is the benefit of NuGenesis Forms— Reduce implementation and

lid ti ff t


validation effort

Market Specific Forms— Pharmaceutical QC

o USP Methods such as Dissolution, pH, Sterility, Content Uniformity, etc.

Services as Part of Your Projects

Capabilities— Planning & Consultation

Implementation Support— Implementation Support— Software Installation— Validation— Training— Maintenance & Support

Enhancing your Investments— Professional resources


— Efficient project management— Time savings— Cost effective use of resources— Partnership for success


Informatics Online Community

Exclusive community is where Waters customers can access the latest Empower Software and NuGenesis informationthe latest Empower Software and NuGenesis information— Post questions and get answers from your peers and Waters

software experts worldwide

— Read and comment on Blogs written by Waters scientists

— Access special material available only in the Community

Easily link to technical


— Easily link to technical documents, whitepapers, webcasts and support resources

— Get information about upcoming events and user meetings

Inform 2012Waters Informatics Users Conference

Where — May 7- 10, 2012

Barcelona Spain— Barcelona, Spain— Hilton Diagonal Mar Barcelona

Why Attend— Network with colleagues and share

experiences— Gain insight how to best deploy and

use Waters Informatics solutions — Discuss your future technology needs


y gywith Waters Product Managers

Program— Eight tracks that include workshops

and optional tutorials— Waters partner presentations — Plenary presentations

