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File location independence, authenticity of data
files, and the elimination of data redundancy are
just a few of the benefits of file replication based
storage system. In addition, replication based
storage systems can be used effectively for
archiving, backup and restore, and disaster recovery
as well.
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 (Legacy IDS)
- Security: Instrument
data files are stored on local hard drives
may be easily accessible to
unauthorized
individuals.
- 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 file.
- Data Corruption
and/or Data System Failure
Data lost due to data acquisition system failure
or file corruption can be minimized by use of
FRMS™,
as data being acquired are mirrored and
replicated in real time.
- Damaged reputation
Using instrument data 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
efficiency of your employees.
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