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Centralized location of all study related
information, authenticity of associated data files
and attachments, and the elimination of manually
intensive data redundancy procedures are
just a few of the benefits of digitally recording
all study based information. In addition, a
digital laboratory notebook allows superior collaboration
and work sharing, and is ideally suited for electronic
archiving, backup and restore.
For legacy instrument data systems (that do not
meet 21 CFR Part 11 requirements), FRMS™
provides an additional layer of compliance, thereby
allowing these systems to be used in a fully
compliant mode.
- Lack of Compliance
Features (Paper based notebooks)
- Security: Laboratory
notebooks must securely stored to
avoid access by unauthorized individuals. Detail
records must be kept to document its usage.
- Audit
Trail: There are no audit trail of changes made to the
file,
even when made by authorized personnel for
legacy
instrument data systems.
-
eSignatures:
There is no provision of electronic signatures.
- Version Control: There is no provision
to create a controlled version
for each modification made to these files.
- File Folder Loss and
Aging
Files and folders lost due to incorrect filing or
as a result of paper aging can be eliminated by use of
IA-DLN™,
as data being acquired and all data entry are electronically
stored and indexed.
- Damaged reputation
Using a hybrid paper and electronic software and
other systems to acquire and
process clinical data that are not
completely validated, in a non-compliant mode can damage your
company's reputation and even delay FDA's
approval process.
- Productivity
Loss
Legal costs and fines, damaged reputation issues all
negatively affect your efficiency and the
productivity of your employees.
The information in paper lab notebook is
"Static" and can not be easily shared,
searched or reused.
Paper lab notebooks have a limited capacity to
handle multiple data streams that results from
advances in technology.
The method of entering data in paper lab
notebook is tedious and prone to errors due to
pagination, date time stamping, witnessing and
finally creating a complete study based
reports
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