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EnterpriseContent Management
for the Laboratory
Jim Miller
Director of Informatics and
Software
Agilent Technologies
Branden Humphrey
Global Data Archive Program Manager
Pfizer Global Research
Page 2
PETA
BYTE
S
The content explosion…
Source: UC Berkeley, School ofInformation Management & Systems,2003
75% is unstructured
More data will be created over the next three years than in theprevious 40,000 combined
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…and the unfortunate truth
Validation Plans Research Data
Electronic Notebooks
Corporate Records
CDS
ManufacturingBatch Records
Project Management
SOPs
Marketing Collateral
Clinical Trials Instrument Data,Lab Reports
Partners, Customers
LIMS Data
IP Records
Organizations store their content in too many separate locations
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Challenges in dealing with all this data
How can you logically organize this data?How can you make all the data “safe” and secure?How can you make all the different data searchable and shareable?How can you make all the data viewable from different places?How can you handle laboratory data as part of your company’s business processes?
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ECM connects the disconnected enterprise
CDS SOPs
ElectronicNotebooksResearch Data
ProjectManagementCorporate Records
Validation Plans LIMS Data
ManufacturingBatch Records
IP Records
Marketing Collateral
Partners,Customers
Instrument Data,Lab ReportsClinical Trials
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With instant, secure access to your data
IntranetIntranet
InternetInternet
GC
CE
LC
Lab-on-a Chip
GC/MS
LC/MS
ICP-MS
UV-vis
ELNPDF
Images
DrawingsLIMSResearch
MS Office LegacyData
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Getting data into the ECM
Manualaddition
Direct transfer fromexternal databasesystems, e.g. LIMS
Automatically throughScheduled Import Services
“Print“ PDF filesdirectly to the ECM
Hardcopy Printer
ECM Print Service
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Organizing the ECM repository
Intuitive hierarchy- Account- Locations- Cabinets- Drawers- Folders
Configure to fit your needs
Data organization byProject
Data organization byDepartment
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Double Click to View
Accessing, viewing and managing data
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Double Click to View
Accessing, viewing and managing data
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Accessing, viewing and managing data
Right click to accesscommon functions
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Indexing data for easy retrieval
File importedMetadata extracted and saved to the database
HeaderOperator ID Run DateMethodMethod Revision
InstrumentInstrument IDFirmware versionMakeModel
SampleSample IDSample TypeSample Source
Attribute Extraction Services available for many file types
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Indexing data for easy retrieval
File importedMetadata extracted and saved to the databaseFile placed in the secure repositoryDB updated with file pointer
Link
HeaderOperator ID Run DateMethodMethod Revision
InstrumentInstrument IDFirmware versionMakeModel
SampleSample IDSample TypeSample Source
Attribute Extraction Services available for many file types
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Indexing data for easy retrieval
File importedMetadata extracted and saved to the databaseFile placed in the secure repositoryDB updated with file pointerIndex can be re-keyed to add attributes
Link
HeaderOperator ID Run DateMethodMethod Revision
InstrumentInstrument IDFirmware versionMakeModel
SampleSample IDSample TypeSample Source
Attribute Extraction Services available for many file types
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Search tools to mine heterogeneous data
Find exactly what you need – fast!!
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Keeping your content secure & compliant
Login securityAudit trailElectronic signaturesSecure (SSL) data transferRecord version controlCheck in / Check outAccess controlled through roles
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Managing Excel spreadsheets in a regulated environment
Security access to cells consistent with the ECM security modelComplete cell-by-cellaudit trailLimited user interaction(data entry only)
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Supporting SAFE (Secure-Access-for-Everyone)
New global standard for legally binding electronic signatures from a consortium of bio-pharmaceutical companiesUsed in lieu of wet signature and notarization for high security applications and protection of intellectual propertyKey components:- Secure ECM repository - SAFE eSignature Plug-in- Kyberpass TrustPlatform- Trusted Third Party PKI Infrastructure
www.safe-biopharma.org
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Managing laboratory business processes
Streamline, automate, and optimize laboratory business processes Define, configure and deploy without programming Applications:- Compliance- Core process and systems consolidation
- Six Sigma quality improvement
Business Process Manager example
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Managing the complete lifecycle of electronic records
ECM supports hierarchical storage management and multiple retention policies
Database
Retention Policy
Time
Metadata
File Server
Archive
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Preserving legacy data with TNF
Technology Neutral File Format: a new standard format based on XMLConvert proprietary chromatography records (raw data, results, meta data) to TNF for preservation and reuseConverters available for HPLAS and Thermo MultiChrome*; next releases will be Beckmann Peak Pro, and PE Turbochrom
TNFService
Converter 1
Converter 2
Converter 3
Converter 4SSIZip SSIZipTNF
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ECM architecture that grows with you from single laboratory…
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…to global deployment
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3 things to remember about ECM…
Provides a secure, central repository and rich content services for capturing, managing, archiving, collaboration and re-use of business critical informationImproves compliance with corporate and regulatory requirements for managing electronic recordsEnhances productivity, increases operational efficiency and streamlines laboratory business processes
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Agilent Laboratory Informatics
www.agilent.com/chem/labinformatics
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Agilent Cerity ECM Web SeminarData Archival Challenges
Branden HumphreyLab Data Archive Program Manager
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Discussion Topics
i The problemi Scope of the projecti Information Architecturei Types of data to managei Implementation OverviewiHow ECM met our needs
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The problem
iHow many people use the Internet and find it invaluable?
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The problem
iHow many people use the Internet and find it invaluable?
iHow many people get frustrated when trying to find information on their own PCs or company file shares?
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The problem
i Huge amounts of data to collect and catalogi Constant change in lab instruments i Data physically located everywherei Limited knowledge that the data exists i Difficulty sharing datai Scientists distracted by data management
duties
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The problem
So, how do we collect all of this data…
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The problem
…without creating a huge
Data Landfill!
So, how do we collect all of this data…
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Scope of the Project
i Three countries, 2 languagesi Deploy to Pfizer Global R&D for 4 Discovery4 Safety Sciences4 PDM (Drug Metabolism)4 Pharmaceutical Sciences
i Use ranges from real-time to true archivali Global data sharing – search and retrieval
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Information Architecture
Data Warehouses:Locked downFinal Results
TransactionalDatabases:
LIMS, eNotebooks
Cerity ECM:Raw Data, Spectra
Processed Data Files
Dat
a Pu
blis
hing
Visualization Tools
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Types of Data to Manage
i All types of laboratory datai Chromatography and Mass Spec to Differential
Scanning Calorimetry and Electron Scanning Microscope
i Text, graphics, raw and binary data filesi Standard, custom and proprietary formatsi Various Record Retention reasons 4 Regulatory,4 Legal / Patent Defense4 Business value
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Implementation Overview
i Deploy separate regulated and non-regulated systems
i Use Federated Architecture4 Global file catalog 4 Site-based file storage (start @ 4.5 TB/Year)
i Run agents on virtual machinesi Leverage Agilent to perform system installationi Define Metadata Standardsi Develop Discovery Search and Link API
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How ECM met our needs
i Automates File Cataloging4 Can customize to any file format
i Automates scheduling of data collectioni Provides secure, highly scaleable platformi Permits global workload sharingi Supports integration with other applicationsi Off-loads scientist of data management dutiesi Enables centralized support modeli Enables hardware consolidation, tiered storage
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Questions
Your moderator isDavid Markovitz, Co-Founder and President
Institute for Effective Innovationserving the FDA regulated industries• World-class training, consulting and coaching • Proven tools to equip your work groups and teams• Innovation Boot Camp™
GMP Training SystemReady-to-Use Modules™Designed for Internal GMP Training
FREE sample - Go to www.GMPTrainingSystems.com
Thank You
All attendees for your attentionAll attendees for your attentionOur panelOur panel
-Branden Humphrey, Pfizer Global Research, for a very interesting case study
-Jim Miller, Agilent Technologies, Director of Software and Informatics
-David Markovitz, Institute for Effective Innovation, for moderation
For more information on Cerity ECM visit:www.agilent.com/chem/CerityECM
For more information on the Agilent’scompliance program visit:www.agilent.com/chem/regulated
Please join Agilent Technologies for future webcasts later in 2005
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