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