Enterprise Content Management

Enterprise

Content Management

for the Laboratory

Jim Miller Director of Informatics and Software Agilent Technologies Branden Humphrey Global Data Archive

Program Manager Pfizer Global Research

PETABYTES

The content explosion…

75% is unstructured

More data will be created over the next three years than in the previous 40,000 combined

…and the unfortunate truth

Validation Plans Research Data

Electronic Notebooks Corporate Records CDS Manufacturing Batch Records Project Management SOPs Marketing Collateral

Clinical Trials Instrument Data, Lab Reports Partners, Customers

LIMS Data

IP Records

Challenges in dealing with all this data

ƒ How can you logically organize this data?

ƒ How can you make all the data “safe” and secure?

ƒ How can you make all the different data searchable and shareable?

ƒ How can you make all the data viewable from different places?

ƒ How can you handle laboratory data as part of your company’s business processes?

ECM connects the disconnected enterprise

Validation Plans LIMS Data

Marketing Collateral Partners,

With instant, secure access to your data

Getting data into the ECM

Manual addition

Direct transfer from external database systems, e.g. LIMS

Automatically through Scheduled Import Services

“Print“ PDF files directly to the ECM

Hardcopy Printer

Organizing the ECM repository

Double Click to View

Double Click to View

Accessing, viewing and managing data

Right click to access common functions

Indexing data for easy retrieval

ƒ File imported

ƒ Metadata extracted and saved to the database Header Operator ID Run Date Method Method Revision Instrument Instrument ID Firmware version Make Model Sample Sample ID Sample Type Sample Source

Indexing data for easy retrieval

ƒ File imported

ƒ Metadata extracted and saved to the database

ƒ File placed in the secure repository

ƒ DB updated with file pointer Link Header Operator ID Run Date Method Method Revision Instrument Instrument ID Firmware version Make Model Sample Sample ID Sample Type Sample Source

Indexing data for easy retrieval

ƒ File imported

ƒ Metadata extracted and saved to the database

ƒ File placed in the secure repository

ƒ DB updated with file pointer

ƒ Index can be re-keyed

to add attributes Lin

k Header Operator ID Run Date Method Method Revision Instrument Instrument ID Firmware version Make Model Sample Sample ID Sample Type Sample Source

Search tools to mine heterogeneous data

Keeping your content secure & compliant

ƒ Login security

ƒ Audit trail

ƒ Electronic signatures

ƒ Secure (SSL) data transfer

ƒ Record version control

ƒ Check in / Check out

Managing Excel spreadsheets in a regulated

environment

ƒ Security access to cells consistent with the ECM security model

ƒ Complete cell-by-cell audit trail

ƒ Limited user interaction (data entry only)

Supporting SAFE

(Secure-Access-for-Everyone)

ƒ New global standard for legally binding electronic signatures from a consortium of bio-pharmaceutical companies

ƒ Used in lieu of wet signature and notarization for high security

applications and protection of intellectual property

ƒ Key components:

- Secure ECM repository

Managing laboratory business processes

ƒ Streamline, automate, and optimize laboratory business processes

ƒ Define, configure and deploy without programming

ƒ Applications:

-Compliance

-Core process and systems consolidation

-Six Sigma quality improvement

Managing the complete lifecycle of

electronic records

Preserving legacy data with TNF

ƒ Technology Neutral File Format: a new standard format based on XML

ƒ Convert proprietary chromatography records (raw data, results, meta data) to TNF for preservation and reuse

ƒ Converters available for HPLAS and Thermo MultiChrome*; next releases will be Beckmann Peak Pro, and PE Turbochrom

TNF Service Converter 1 Converter 2 Converter 3 Converter 4 SSIZip TNF SSIZip

ECM architecture that grows with you from

single laboratory…

3 things to remember about ECM…

ƒ Provides a secure, central repository and rich content services for capturing, managing, archiving, collaboration and re-use of

business critical information

ƒ Improves compliance with corporate and regulatory requirements for managing electronic records

ƒ Enhances productivity, increases operational efficiency and streamlines laboratory business processes

Agilent Laboratory Informatics

Agilent Cerity ECM Web Seminar

Data Archival Challenges

Discussion Topics

i

The problem

i

Scope of the project

i

Information Architecture

i

Types of data to manage

i

Implementation Overview

The problem

i

How many people use the Internet and find it

invaluable?

The problem

i

How many people use the Internet and find it

invaluable?

i

How many people get frustrated when trying to

find information on their own PCs or company

file shares?

The problem

i

Huge amounts of data to collect and catalog

i

Constant change in lab instruments

i

Data physically located everywhere

i

Limited knowledge that the data exists

i

Difficulty sharing data

i

Scientists distracted by data management

duties

The problem

The problem

…without creating

a huge

Data Landfill!

So, how do we collect all of this data…

Scope of the Project

i

Three countries, 2 languages

i

Deploy to Pfizer Global R&D for

4

Discovery

4

Safety Sciences

4

PDM (Drug Metabolism)

4

Pharmaceutical Sciences

i

Use ranges from real-time to true archival

Information Architecture

Visualization Tools

Types of Data to Manage

i

All types of laboratory data

i

Chromatography and Mass Spec to Differential

Scanning Calorimetry and Electron Scanning

Microscope

i

Text, graphics, raw and binary data files

i

Standard, custom and proprietary formats

i

Various Record Retention reasons

4

Regulatory,

4

Legal / Patent Defense

Implementation Overview

i

Deploy separate regulated and non-regulated

systems

i

Use Federated Architecture

4

Global file catalog

4

Site-based file storage (start @ 4.5 TB/Year)

i

Run agents on virtual machines

i

Leverage Agilent to perform system installation

Define Metadata Standards

How ECM met our needs

i

Automates File Cataloging

4

Can customize to any file format

i

Automates scheduling of data collection

i

Provides secure, highly scaleable platform

i

Permits global workload sharing

i

Supports integration with other applications

i

Off-loads scientist of data management duties

i

Enables centralized support model

Your moderator is

David Markovitz,

Institute for Effective Innovation

serving the FDA regulated industries

• World-class training, consulting and coaching

• Proven tools to equip your work groups and teams

• Innovation Boot Camp™

714-289-1233

info@GMPTrainingSystems.com

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sample - Go to

Thank You

ƒ

ƒ

All attendees for your attention

_{All attendees for your attention}

ƒ

ƒ

Our panel

_{Our panel}

-Branden Humphrey, Pfizer Global Research, for a very interesting case study

-Jim Miller, Agilent Technologies, Director of Software and Informatics

For more information on Cerity ECM visit:

www.agilent.com/chem/CerityECM

For more information on the Agilent’s

compliance program visit:

www.agilent.com/chem/regulated

Please join Agilent Technologies

for future webcasts later in 2005