Toward Semantic Representation of Science in Electronic Laboratory Notebooks (ELNs)
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Transcript of Electronic Lab Notebooks (ELN) - · Electronic Lab Notebooks ... yRecords Management / Retention...
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