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Electronic Laboratory Notebooks in Pharmaceutical R&D: On the Road to Maturity

Sandeep patial

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Technology Review

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Electron
in Pharm
Technology Review

  For scientists who work in regulated areas, notebook pa-
ges are reviewed by a reviewer and sometimes approved
by a supervisor. The reviewer and approver must be
trained on the subject’s matter and, at a minimum, capa-
ble of determining the suitability, accuracy, and effective-
ness of the study.
  Tracking key information such as compound registration
number, project name, author, experimental method,
date, and other keywords.
  Ability to map key metadata, such as project names, from
discovery to development for data retrieval.
  Linking all pages related to a compound for easy retrieval

Road to
   After the notebooks are complete, they are archived. of chemical synthesis, stoichiometry, analysis, and spectra

Most companies aboratory

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activitie
also create m 2/9
 Most companies aboratory activitie
L
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
 
also create
Translate PDF
m
Keywords:
notebooks. planning, experim Technology Review

electronic
expected to stand up in a patent dispute.
collection, processing,
systems should at least meet the same standards if it is

Long-term data retention and accessibility is also a com-

mon requirement. The difference between non-GxP and
GxP user requirements primarily lies in the particular func-
continuum. Significant gains in record-keeping efficiency
and data quality may also be achieved by integrating ELNs
with data acquisition systems. Without integration, data
must be transcribed manually or imported with human inter-
vention, a step that is likely to introduce errors and slow

laboratory  systems significantly. N

tions and requires appropriate flexibility for each discipline.
Intellectual property (IP) protection is the primary concern
in a discovery lab. ELN data are required to be signed by
down data processing steps.

ELN AS AN INTEGRAL PART OF THE ELECTRONIC

the author and a knowledgeable witness within certain period LABORATORY

notebooks,
of time after the data are entered. GxP environment calls for

routinely implemented
ELN,WHY ELECTRONIC LABORATORY NO
quality of work in eve
electronic records,
Bound notebooksexception
have been used
is the as t
labor
electronic signature,
scientific discoveryslow
in the history
to ‘‘go of sci
electronic
data archiving,
successful, because most ofbegan
 technology the exp
to i
pharmaceutical
were recorded manually.
started However,
to implement w
R&D
mation and sophisticated instrumen
(ELNs). Because the la
branches of pharmaceutical R&D, p
evidence for the owne
books became anachronism. Scienti
concerns on whether
general categories, raw data and proc
evidence for invention
  mated laboratory environment, raw
adopters by
an instrument, recorded of ELN
datatech
co
processed by data entering datasoftware
analysis electron
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
specific,
Translate PDF
representprintouts.
typicallywell-defined However,
experimental
the conclusions oft
des
Technology
very Afew variations.
common Review
Adhering
concerns
practice today to
is atostan
as regulatory ha
dure is of paramount
and procedures in importance
the paper
 What is laborato
important is in
th
Such procedures analyze
the experiment, require
should be that
the ELNdata
raw
managed dapr
thor,
ware,reviewed
print thefor accuracydata,
processed by a review
 trustworthiness. and
There
approved
book next by to
a laboratory
the manager
conclusions.
ELNs, the bef
Thi
most signific
leased. Suchthat
limitations procedures
affect are put
scientists’ in
produ
records electronically.
pl
ment to ensure that data are accurat
1. Data in the paperincreases productivity
notebooks cann
a patient’s safety is not compromised
searched, andsupervisors
reanalyzed.in R&D. T
project to be successful, specific fun
2. Cut and pastesupport
is tedious.data in discov
and non-GxP areas must be met.
3. Paper record-keeping standards a
 
The ELN business process roles can
typical categories
Electronic (Table 1),
laboratory each
notebooks
*Correspondence: ofDu
Ping w
Technology Review

tasks
systemsto used
ensure Dr,
forthat Irvine, CA storing,
92612; Phon
the records
creating, enter
allergan.com
accurate, authentic,
fully electronic recordsandintrustworthy.
ways that m
1535-5535/$32.00
The starting
technical, and point
scientificof any ELN imp
requirement
Copyright  c  2007 by The
understanding
serve the purposeof the existing
of daily record
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keepi 4/9
5/19/23, 9:23 AM
g
se ve t e pu pose o da y eco g d eep
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Translate PDF doi:10.1016/j.jala.2007.01

ELN workflowsDiary’’
are presented in Figu


vide ‘‘Analyst functionality fo

providing the functionality
tist. Managing notebook data of the pa
electro
hances the organizational
the limitations efficiency
of bound notebooks.
transfer of scientific information and p
search, development, and manufactur
BASIC
the technology transfer process betw
USER REQUIREMENTS
work in different stages of the
Because ELNs significantly affect the
flow for an enterprise, it must meet the
 

Table
and 1.  Electronic
have laboratorybenefits
enough potential notebook t
Technology Review

must weigh the cost/benefit ratio car

D
areas, because the transition from pap
 Author Author has rights to
quire significant effort. Below are som
 with all sources of a
be considered in order for the ELNs
his or her own exp
tutes of paper-bound notebooks.

158 JALA
Table June 2007benefits
2 Measurable
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of electro
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158   JALA   June 2007benefits
(62) Electronic Laboratory Notebooks in Pharmaceutical R&D: On the Road to Maturity | Sandeep patial - Academia.edu
Table 2.   Measurable of electro
  Witness/reviewer
Translate PDF Witness is the person
experiment and pr
ownership of a stu
potential inventor.
Cloning experiment design
Experiment review and sign-off 
Reduced
Figure manual
1.   data transcription
Electronic laboratory
 Approver Not applicablenotebo
 Ability to search
and reviewing andata and avoidTasks
experiment. repetitions
for th
in performed
blue. Tasksalready 
for the Reviewer are highl
Eliminating the need to archive paper note
Integration with instrument and other appl
One access
Secure of the complicated aspect
to data
integration is multiple data standard
information exchanges between syste
maceutical industry needs a common
data
dates,repositories,
and names.which are required
The time vendor in
ing or such
data, reviewing of analytical
as synthetic instrum
procedures
f i M k L A IML
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 formation
for patent  M
Translate PDF arkup
filing, can L anguage, AnIML
be significantly r
ASTM
the timeInternational
needed to gatherSubcommittee
data requiE
4
analytical instrument
query, or an inspection. data. AnIML
cord dataELNs
Most from everyday
that are experimental
currently avai
5
tory
tools environment.
to compile the However,
special AnIML
reports whe
Figure 3.  Common workflow and data
most ELN vendors.
imentsdesigned, started, andcomplete
At period,
fined the database
can belevel, most ELN
summarized. Thp
tional
There
present databases,
are many
some such
statistics as Oracle
benefits
suchinas
using
numband
E
guage
scientific (SQL)
experiments Server. reviewed,
information,
pending As a result,
including inte
ease
and av
and other
data, systems
increased can in
quality berecord
achieved
keepu
Benefits
to IP andfor the Scientist
regulatory policy, and op
160   JALA
ELNs   June 2007
alsowould
enable better knowledge m
ELNs save valuable time by
late cultural changes
of repetitive tasks. for more open da
tion sharing among scientists. Therefo
of ELNs canExtra
Eliminating be grouped
Steps in as general
Notebook
the scientists,
regulated benefits forthe
environment, the use
witness
of po
fits for records
requires management.
scientists to follow through
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 requires scientists tog follow through
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steps, repetitively. These monotono

eliminated in the electronic setting. S
notebooks or collecting ‘‘wet’’ sign
Key Value Metrics
needed. Time spent in searching fo
The be
could benefits of ELNs
reduced due tocan be measur
ELNs’ link
culated for provide
which can return on
theinvestment
definition (RO
auto
here the complex financial compu
Simplified Record Keeping.  With ELN
itive steps can be avoided while mainta
cess. For example, there is no need to
from’’ and ‘‘continued to’’ fields tha
page of a paper notebook. The ‘‘cut an
will be eradicated. Writing a notebo
attachments, signing, and dating ev
an experiment would be eliminated.
initialing and dating across the edge
b d
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Although ELNs eliminate those st

that ELNs may be configured to ca
(such as experimental conditions) th
record in paper notebooks. Althoug

162   JALA   June 2007

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