UGS Corp.. Copyright © 2004. All rights reserved.

Electronic Lab Notebooks (ELN)

PLM World 2006

Product Lifecycle Digital Transformation

UGS Vision for pharma research data management

Fragmented architecture, data and application silos

Need for an integration platform

Need for Generic templates for organizing experimental data

Need for data structure enabling quick access and navigation

Need for flexible way of managing data access rights

Need for new concepts related to Research knowledge management

Business Goals

Increase researcher productivity by 20%

Promote knowledge reapplication

Eliminate paper and paper based microfilming

Reduce legal response time

Early identification of patentable ideas

Streamline records management

Business Processes

Authoring and witnessing primary lab notebook records.Capturing instrument data as adjunct records and relating them to primary records.Record life cycle management.Identification of patentable ideas and initiation of patenting process.Litigation support

Key Roles

ELN AuthorWitnessResearch SupervisorInternal Records AdministratorRecords ManagerPatenting OfficeLegalSystem Administrator

Optimized Functional (vertical) Systems

Typical Environment - Fragmented Architecture

External DB

Project Management & PlanningPlanning, Allocation, & Tracking

LIM

SLI

MS

LIM

S

Clin

ical

Supp

lies

Non

-LIM

SN

on-L

IMS

TID

VAL

Team Space

LIMS Servers

Form

ulat

ion

Wor

ksta

tion

Oracle Documentum

Indi

vidu

alSy

stem

s

PaperNotebooks

ProductFocus?

Suppliers

Hard Drive

Ana

lytic

alW

orks

tatio

n

TCE Oracle

• • •

Pat

h/To

x

Key Concepts

Notebook

Primary Record

Adjunct Record

Microfilm

RMA Concepts (RMA Folder, File Plan, Audit Record, Disposition Phase, Disposition Schema)

Adjunctive NotebookPrimary Notebook

Solution Strategy: Typical ApproachC

ompo

und

Synt

hesi

s

Bio

Info

rmat

ics

Bio

Info

rmat

ics

In V

ivo

Bio

logi

stIn

Viv

o B

iolo

gist

In V

itro

Bio

logi

stIn

Vitr

o B

iolo

gist

Pha

rmac

olog

ist

Pha

rmac

olog

ist

Adj

unct

ive

Not

eboo

kN

ugen

esis

Adj

unct

ive

Not

eboo

kC

yber

labs

LIM

SLa

bVan

tage

Lab Instruments

U1

Slide 9

U1 Add Odyssey as a functional bar.

Add as "New" or "Existing Function"?UGS, 4/17/2006

ELN/LIMS Architecture

PLM Platform(Workflow, Multiple Data Contexts, Integration)

Project Management &Planning

Planning, Allocation, & Tracking

Product Area & FAProjects & FA Context and Data

References Records ManagementLong Term Storage, eSignature,

Format Conversion, Index Creation,Searching, Security

Ext

erna

lCol

labo

ratio

n

Adj

unct

ive

Not

eboo

k

Nugenesis

LIMS(GAIMS)

LabVantage

Lab Instruments

CyberLab

Adj

unct

ive

Not

eboo

k

Vertical Authoring ToolGeneral Authoring-

Microsoft Office

Primary Notebook

Form

ulat

ion

Wor

ksta

tion

Ana

lytic

al W

orks

tatio

n

Clin

ical

Sup

plie

s

• • •

In V

ivo

Bio

logi

st

Bio

stat

istic

s

Pha

rmac

olog

ist

In V

itro

Bio

logi

st

Records Management Perspective

Records – data/content to be managed (tax information)

Record Format (Form 1040)

Record Media (paper, electronic)

Record Folders – organizers for records

Folder Cutoff – collect and process annually

Disposition Schedule/phases

collect annually

file by April 15th

retain returns & supporting information for 4 yrs

retain returns for 10 yearsRecord Retention

Electronic NotebookDisposition Schedule

Phase 1 (< month)

Event

t

Publicize new knowledge reports

and notebook records in central

vaults

New Folders Created

Monthly Cutoff

Destroy knowledge reports and notebook records

Phase 2 (100 years)

Time

ELN Simplified Process Flow

ELN Website

Vertical Application

Data Screen

Data “Promoted”

to ELN

Template Chosen or Created

Data Entered and/or

Linked to Adjunctive

Data Data

Converted and

Transported via PLM Platform

e-Signature Processed

Data Archived and Indexed

Data Printed and Signed

Data Retrieved via PLM Platform

Project Data Views

Key Custom Features

Notebook and Record Concepts

Integration with adjunct data

Digital signatures

MS office Integration

Acrobat Server Extension integration

UI customization/configuration

Records Management Configuration

Research and PurposeResearch and Purpose

ELN/PLM R&D Platform

Notebooking, Records, Management, Process, Search/Index, Reports, RegulatoryIP

MS OfficeWordpptxl

ChemistryAuthoring

e.g., Gensys,ChemPro,

etc.

GeneticsApplication

InstrumentsNuGenesisLabVantagedirect print

Other

Objective Purpose

(See inset Below)

Logical Architecture

Notebook

Primary Record

Adjunct Record

Universal HierarchyProject/Product

IP Mgt

Function/Methods

Knowledge Push

Objective Purpose(Context) Exploration

ELN 2007 Features

Record AuthoringPrimary

Adjunctive

Digital Signature

Records Management / Retention

Reports

NuGenesis Integration

CyberLabs Integration

* See Speaker Notes for Amplification

Demo/AVI

Record AuthoringPrimary

Adjunctive

Digital Signature

Records Management / Retention

Reports

NuGenesis Integration

CyberLabs Integration

* See Speaker Notes for Amplification

In summary

UGS provides :A proven integration platform for all research applications

A system that is referencing and structuring all data

ELN capabilities integrated in this platform

An innovative approach validated in an industrial way