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EtQ recognizes the enormous
task of FDA
Compliance, and has
optional services to help
regulated companies quickly
and confidently validate
their EtQ environment.
EtQ Validation Services
provides three optional
choices to assist the FDA
regulated customer to meet
the FDA's validation requirements.
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| Documentation
and Training |
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To leverage
the investment
of an organization's
internal validation
resources, EtQ
provides sample
documentation
and classroom
training on
the documentation
to assist the
customer with
their validation.
The documents
and training
dovetail with
EtQ's installation
service and
administration
training service,
providing the
customer with
a clear path
to follow in
validating their
implementation
of EtQ's
FDA Compliance
Software |
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| Documentation,
Training and Configuration |
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To maximize
the investment
of an organization's
internal validation
resources, EtQ
will provide
the documentation,
classroom training
on the documentation,
and will revise
the requirements
documents defining
the configuration
and test scripts
necessary to
validate the
core EtQ implementation
with the customer-specific
configurations.
EtQ will also
modify all other
associated documentation. |
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| Documentation,
Training, Configuration
& Execution |
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those organizations
without validation
resources, EtQ
will provide
the documentation,
classroom training
on the documentation,
configuration
services, will
execute the
test scripts,
and draft the
final reports
necessary to
document the
completed validation. |
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For
companies regulated
by the Food and Drug
Administration (FDA),
systems validation
is a necessary requirement
to ensure a secure
environment. The process
of validating an enterprise
system involves running
test scripts at the
installation level,
the process level
and the operational
level (called IQ,
PQ, and OQ, respectively).
These scripts are
often long and time
consuming, and can
take months, if not
a whole year to compile
and run.
Recognizing this incredible
task of validation,
EtQ has released the
eValidator utility,
which is designed
to automate the PQ
process. The eValidator
is a comprehensive
set of commands that,
when executed, will
run the test scripts
automatically, and
generate a full report
of the results of
this script.
The ramifications
of the eValidator
are staggering. Streamlining
the validation process
can have a tremendous
effect on both a company's
implementation time
and personnel resources.
Using eValidator to
automate the validation
process will cut a
company's validation
time by as much as
400% - a 4 day validation
project can be done
in less than a day
using EtQ's eValidator.
Furthermore, the eValidator
can be run by a single
employee, and can
eliminate the extensive
resources needed to
dedicate to a typical
validation project.
Finally, eValidator
is able to compile
a comprehensive report
library of all tests
and scripts run on
the system. When audited
by the FDA or other
governing body, the
validation reports
are immediately available
for review.
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