enterprise content...

EnterpriseContent Management

for the Laboratory

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

…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

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?

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

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

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

Organizing the ECM repository

Intuitive hierarchy- Account- Locations- Cabinets- Drawers- Folders

Configure to fit your needs

Data organization byProject

Data organization byDepartment

Double Click to View

Accessing, viewing and managing data

Accessing, viewing and managing data

Right click to accesscommon functions

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


File importedMetadata extracted and saved to the databaseFile placed in the secure repositoryDB updated with file pointer

Link






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





Search tools to mine heterogeneous data

Find exactly what you need – fast!!

Keeping your content secure & compliant

Login securityAudit trailElectronic signaturesSecure (SSL) data transferRecord version controlCheck in / Check outAccess controlled through roles

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)

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

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

Managing the complete lifecycle of electronic records

ECM supports hierarchical storage management and multiple retention policies

Database

Retention Policy

Time

Metadata

File Server

Archive

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 long term preservation and reuseConverters available for HPLAS and VG MultichromTM*; next releases will be Beckman PeakProTM* and PE TurbochromTM

TNFService

Converter 1

Converter 2

Converter 3

Converter 4SSIZip SSIZipTNF

* VG MultichromTM and Beckman PeakProTM are properties of Thermo Electron Corpororation

ECM architecture that grows with you from single laboratory…

…to global deployment

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

Agilent Laboratory Informatics

www.agilent.com/chem/labinformatics

1

Agilent Cerity ECM Web SeminarData Archival Challenges

Branden HumphreyLab Data Archive Program Manager

2

Discussion Topics

i The problemi Scope of the projecti Information Architecturei Types of data to managei Implementation OverviewiHow ECM met our needs

3

The problem

iHow many people use the Internet and find it invaluable?

4

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?

5

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

6

The problem

So, how do we collect all of this data…

7

The problem

…without creating a huge

Data Landfill!

So, how do we collect all of this data…

8

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

9

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

10

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

11

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

12

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

13

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™

[email protected]

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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