|
>>VALIDATOR
Core
to
any
pharmaceutical
process
is
compliance,
including
validation
and
21
CFR
Part
11.
Achieving
compliance
can
present
a
significant
demand
on
resources
to
an
organization.
Properly
planned
validation
can
enhance
benefits
in
productivity
and
process
improvements.
Validator
is a
software
solution
for
your
computerized
system
validation
needs
and
21
CFR
Part
11
compliance
requirements.
This
compliance
tool
provides
you:
•
With
a
standard
and
automated
methodology
of
qualifying
and
documenting
your
systems
to
meet
regulatory
scrutiny
•
A
framework
and
strategy
for
computer
system
validation
and
21 CFR
Part
11
•
A
walkthrough
approach
for
planning,
test
case
design,
development,
and
test
execution
to
dramatically
reduce
the
burden
on
resources
to
your
organization
•
The
required
documented
evidence
and
validation
approach
based
on
answers
to a number
of
questions
provided
by
the
user
through
an
intuitive
user
interface
It
makes
use
of
existing
internationally
recognized
standards,
guidelines,
and
industry
best
practices
and
also
can
be
used
to
qualify
all
software
applications
for
prospective
validation,
retrospective
validation,
and
revalidation.
Validator
incorporates
the
following
details
for
any
project:
•
Definition
of
Project
Scope
•
Generation
of
System
Validation
Plan
•
User,
functional,
and
design
requirements
specifications
•
Development
activities
audits
(Functional,
Design,
System
Implementation
Specification)
•
Development
,
approval,
and
execution
of
IQ/OQ/PQ/21
CFR
Part
11
•
Validation
Summary
Report
•
Incident
Review
•
Document
approval
process
(workflow)
Contact us for a demonstration or attend
one of our scheduled events for more information.
|
