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Innovative
Automation’s Digital Laboratory Notebook (IA-DLN™)
software is designed to replace paper based
laboratory notebook currently used in a high throughput
production laboratories in support of drug discovery work.
The DLN is specifically designed to provide an effective
foundation for scientific information management by allowing
all study related data to be aggregated in a electronic
format complete with 21 CFR Part 11 compliant security
features, and according to a good laboratory notebook
practice and significantly aiding in the administration of a
study throughout each study's lifecycle or data retention
time period.
The
DLN™
system empowers scientists and knowledge
workers with a powerful new ways to capture, record,
archive, retrieve, share, and collaborate
regulated and controlled information -- study and protocol
information required to conduct studies, sample control
chain of custody records, sample extraction data, raw instrument
acquisition data, laboratory and field observations, study
and protocol addendums and deviations, etc. It
provides a common and consistent platform for information
sharing and collaboration resulting in improved
productivity. For QA (Quality
Assurance) and RCV (Regulatory Compliance and Validation)
managers, IA-DLN™ server's embedded version control system
ensures data integrity and it's task based user access mode
provides additional layer of data security and
authenticity.
The
IA-DLN™ system when used in conjunction with
Innovative Automation's FRMS™
replication and remote mirroring technologies completely eliminates data loss by
making current data available immediately at an alternate
location.
Finally, IA-DLN™
based information
will successfully sustain the rigors of any inspection,
including inspections from international regulatory
bodies. IA-DLN™
ensures authenticity and integrity of all study data
acquired, within its repository via a system of
user identification, audit trail, e-signature, encryption
and a unique XML based meta data storage repository.
Key Features
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Complete Study Management and an efficient
organization of all study-related information
IA-DLN makes study creation and modification easy
thanks to to its rich functioned and intuitive user
friendly interface.
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User definable templates and forms
User definable templates and forms provide a means
for standardizing procedures and increasing the accuracy
and efficiency of data input. A template library stores
all templates and forms that can be accessed by a simple
point and click. These customizable templates are
built around typical laboratory, user, and study/project
priorities and represent a typical workflow of a study
documentation in clinical and non-clinical studies or in
quality control processes managed by a CRO (contract
research organization).
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Web based user interface allows collaboration
A web based intuitive user interface allows
collaboration among study assigned personals in a secure
environment. The workflow within IA-DLN is
completely customizable and is designed to match both
good laboratory notebook practices, and the way
scientists actually enter records into their laboratory
notebooks.
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Flexible and efficient data entry and upload
IA-DLN allows users to enter data in ways that
provides maximum flexibility and efficiency -- type
directly into it, copy and paste from other data source
or attach data by uploading it in its native format. For
example, a results table, data acquisition method,
chromatographs from API-4000/5000 running Analyst
1.4 can be directly attached to notebook entry.
Similarly, data from entire run obtained from a GC/MS
system running MassLynx can be attached to IA-DLN.
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Create a variety of notebook types
IA-DLN system allows you to create an unlimited number
of notebook types for a given study.
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User definable export
Provision for exporting notebook entries into MS Word,
MS Excel and Adobe Acrobat formats.
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Audit trails
Records
all user actions from editing, signing, witnessing of
entries with date and time stamps while conserving
earlier version of the data. These extensive audit
trails give a permanent record of how and when
information were modified.
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Highly Secure
The IA-DLN
integrates with corporate security systems including
LDAP directories, PKI Tokens and Windows 2000/2003
domain servers. This allows the IA-DLN to
use current corporate security standards and policies in
place.
-
MS Office XP/2003 and Adobe Acrobat (ver. 6/7)
support
Allows for uploading Adobe Acrobat, MS Word,
EXCEL, and PowerPoint files in its native format as
direct attachment to IA-DLN notebook. The
PDF format allows for long-term storage, viewing reliability and
insertion of digital signatures. PDF is widely accepted
in both government and business as the standard
electronic format for documents. The MS Word, Excel and
PowerPoint viewers allows these files to be viewed
without having this application installed via a web
interface.
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User definable reporting
IA-DLN incorporates industry standard Crystal Reports
format reports. These reports can be easily modified and
custom reports can be easily added to the report
repository. The system comes with two groups of
pre-build reports - notebook reports and audit
reports. The notebook reports contain all the working information that you typically
record in a paper-based laboratory notebooks, i.e., the
information, administrative information about the user,
date and time of creation, version number, etc. audit
reports contain the history of all changes and
modifications made by the authorized users complete with
audit log and encrypted electronic signatures.
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