unifi 1.5 scientific information system for regulated ... · 1.5 scientific information system for...

©2011 Waters Corporation 1

Waters Deminar

June 2012

UNIFI™ 1.5 Scientific Information System for Regulated Bioanalysis

©2011 Waters Corporation 2

Waters Regulated Bioanalysis System Solution

• Best in class

Sample Preparation Solutions

• The fastest and most resolving LC without compromise in robustness

ACQUITY UPLC® I-Class

• Different choices for best performance

ACQUITY UPLC Columns

• Most sensitive MS

® TQ-S

• Compliance-ready • Interactive workflow-driven data platform

UNIFI

• Installation, maintenance & training • Compliance services

Service

©2011 Waters Corporation 3

What is UNIFI?

A single software platform that unites our end-to-end system solutions; instrumentation, separations chemistry, methods, reporting templates, and support

A single informatics solution for chromatography and mass spectrometry that simplifies method transfer, minimizes training and improves collaboration

Elegant user interface adjusts to roles and capabilities of users; tailored to workflows and maximizes system usability

Industry leading security, compliance configurations; built in change control tools for the regulated or non-regulated laboratory

Scalable, open architecture provides a future proof system solution that can grow as your needs grow

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UNIFI Scientific Information System

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A task based, work-flow oriented application that unites our end-to-end system solutions

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N-tier architecture

DATABASE

APPLICATION LAYER ACQUISITION CONTROL

Reporting Data Processing

Event Center Audit Trails

Document Approval Security

Xevo TQ-S

PORTAL CLIENT

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N-Tier Deployment

Layers define logical not physical separation — Layers can be physically deployed as necessary to meet

system requirements o i.e. Workstation or Enterprise

Allows to scale UNIFI based on customer needs o No code changes required o Reduces evaluation effort

UNIFI Installation — Always has Single Logical

Database and Business Layer

Workstation Workgroup Enterprise

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Scalable, open architecture allows for future growth and sharing of information

Workstation Installation Instrument System

Instrument Control

Presentation Layer Business Layer Database Layer

All components on a single secure workstation

Purpose built Application Workflow and Configurable Security

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Scalable, open architecture allows for future growth and sharing of information

<< LABORATORY NETWORK >>

Laboratory Network Device

Instrument Control

Server

Presentation Layer

Presentation Layer

Client PC Client PC

Business Layer Database Layer

Instrument Control

Laboratory Network Device

Presentation Layer Capture Agent

Client PC

Secure Data Center

Enables Managed Information Sharing & Simplifies Compliance Efforts

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Portal Client Deployment

Minimize Client Footprint — Portal Client only

o Mostly graphical display — Reduce End User Software Validation concerns

o No Data Processing is performed within Portal Client o No settings or data stored locally

Portal Client software automatically deployed as needed –

— “Trickle Down” using tested executable — Built in check process

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Localized language support facilitates business globally

Scalable, open architecture allows for future growth and sharing of information

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Easily Fits Into and Guides Customers Processes

From Wikipedia, the free encyclopedia A workflow consists of a sequence of connected steps. It is a depiction of a sequence of operations, declared as work of a person, a group of persons,[1] an organization of staff, or one or more simple or complex mechanisms.

Step 1 Step 2 Step 3 Step 4 Step 5 Step 6

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Step 1 Step 2 Step 3 Step 4 Step 5 Step 6

Search for reference document

Review quality specifications

Develop validated method

Review batch results of validated method

Verify critical quality criteria

Review, sign & release

Simple Bioanalysis Workflow

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Step 1 Step 2 Step 3 Step 4 Step 5 Step 6

Search for Reference Document

Search

Role

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Review Quality Metrics in Regulatory or SOP Documents

Search

Step 1 Step 2 Step 3 Step 4 Step 5 Step 6

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Measure and Optimize

Tools determined by Role

Develop a Validated Method ; In This Case the Matrix Effect Analysis

Step 1 Step 2 Step 3 Step 4 Step 5 Step 6

Sample list configured for a post column infusion matrix effect analysis

Start running samples

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Review Batch Results; Look for Quality Issues

Batch quality easily assessed

Step 1 Step 2 Step 3 Step 4 Step 5 Step 6

Tools determined by Role

Role

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Verify Critical Quality Criteria

Configure Tools to look at critical criteria such as LLOQ automatically

Step 1 Step 2 Step 3 Step 4 Step 5 Step 6

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Electronically Review, Sign and Release

Step 1 Step 2 Step 3 Step 4 Step 5 Step 6

Role

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Schematic Workflow for MassLynx 4.1 XML LIMS Interface

MassLynx

• QLD

Pull all data into memory

• XML

Push to Watson IM Integration Point

• XML

Converted by Watson IM

• LML

Watson LIMS

• Pull into Watson Study

Thermo Integration Manager

Wat

son M

assL

ynx

Filter

ML 4.1 XML LIMS Interface

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Integration with WATSON LIMS

Watson LIMS BioAnalyst

Use Thermo Integration Manager Will work with all Waters Software Should work with multiple Thermo LIMS Watson will provide validation of interface

UNIFI

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Thermo Integration Manager with UNIFI

UNIFI

Built in LIMS Interface Run and Process Sample Set

• UDF

Pull all data into memory

• XML

Create Sample List

Collects Results

• XML

Convert S List Converted Results

• LML

Watson LIMS

• Pull into Watson Study

Thermo Integration Manager

Wat

son U

NIF

I Fi

lter

UNIFI LIMS Interface UNIFI Database

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Step 1 Step 2 Step 3 Step 4 Step 5

Create Analysis from LIMS Sample List

Review Results and Verify Quality Measures

Electronically approve the batch result report

Select batch result analysis for export

Verify batch selection then export

UNIFI Workflow with Watson LIMS

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Step 1 Step 2 Step 3 Step 4 Step 5

Create Analysis Then Pick a Sample List

Click

Select

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Step 1 Step 2 Step 3 Step 4 Step 5

Review Results and Verify Quality Measures

Evaluate

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Step 1 Step 2 Step 3 Step 4 Step 5

Electronically Approve the Batch Result Report

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Select the Batch Result Analysis for Export

Export

Step 1 Step 2 Step 3 Step 4 Step 5

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Step 1 Step 2 Step 3 Step 4 Step 5

Verify Batch Selection Then Export

Click

Export

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How Does UNIFI Help the Customer with Productivity?

Scalable, open, enterprise architecture provides — protection of data, — sharing and re-use of information and — reduces the cost of change

Built in Oracle Database — Secures records — Permits storage of Office or PDF documents such as SOPs — Allows you to search and retrieve data quickly

Single software platform, easily learned once and expanded as desired

Purpose built work flows/tools for: — Secure connection to Watson LIMS

— Matrix Effect Analyses

— Batch Quality Analysis/Review

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Future of UNIFI and existing solutions

BioPharm System Solution

Software Unification: Prove model

Enterprise Implementation: Personalization More than 10 workgroups Global

Acquity/Xevo Tof

LC Software MS Software SDMS

EMPOWER

MASS LYNX

SDMS NuGenesis

Expansion of System Solutions Applications & Instruments

EMPOWER

MASS LYNX

SDMS NuGenesis

Business Continuity: Support Revenue

LC/MS configurations

LC Software MS Software SDMS

Expand Footprint/ Small Network Prove scalability & standards viability Open Architecture Instruments centraldata acquisition

Multi-vendor

LC Software MS Software SDMS

Current Portfolio

WorkStation

Workstation Workgroup

Enterprise System

Data migration to single platform

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What Will YOU Do With

No compromises. More Choices

Focus on Science

Partnering for the complete solution

Invest for today

and future

Leverage Technology in real time